1  319 220 AN INTERVENTION WITH DANCE AND YOGA FOR GIRLS WITH FUNCTIONAL ABDOMINAL PAIN DISORDERS (JUST IN TIME): PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: FUNCTIONAL ABDOMINAL PAIN DISORDERS (FAPDS) AFFECT MANY CHILDREN WORLDWIDE, PREDOMINANTLY GIRLS, AND CAUSE CONSIDERABLE LONG-TERM NEGATIVE CONSEQUENCES FOR INDIVIDUALS AND SOCIETY. EVIDENCE-BASED AND COST-EFFECTIVE TREATMENTS ARE THEREFORE STRONGLY NEEDED. PHYSICAL ACTIVITY HAS SHOWN PROMISING EFFECTS IN THE PRACTICAL MANAGEMENT OF FAPDS. DANCE AND YOGA ARE BOTH POPULAR ACTIVITIES THAT HAVE BEEN SHOWN TO PROVIDE SIGNIFICANT PSYCHOLOGICAL AND PAIN-RELATED BENEFITS WITH MINIMAL RISK. THE ACTIVITIES COMPLEMENT EACH OTHER, IN THAT DANCE INVOLVES DYNAMIC, RHYTHMIC PHYSICAL ACTIVITY, WHILE YOGA ENHANCES RELAXATION AND FOCUS. OBJECTIVE: THIS STUDY AIMS TO EVALUATE THE EFFECTS OF A DANCE AND YOGA INTERVENTION AMONG GIRLS AGED 9 TO 13 YEARS WITH FAPDS. METHODS: THE STUDY IS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AMONG GIRLS AGED 9 TO 13 YEARS WITH FUNCTIONAL ABDOMINAL PAIN, IRRITABLE BOWEL SYNDROME, OR BOTH. THE TARGET SAMPLE SIZE WAS 150 GIRLS RANDOMIZED INTO 2 ARMS: AN INTERVENTION ARM THAT RECEIVES DANCE AND YOGA SESSIONS TWICE WEEKLY FOR 8 MONTHS AND A CONTROL ARM THAT RECEIVES STANDARD CARE. OUTCOMES WILL BE MEASURED AT BASELINE AND AFTER 4, 8, 12, AND 24 MONTHS, AND LONG-TERM FOLLOW-UP WILL BE CONDUCTED 5 YEARS FROM BASELINE. QUESTIONNAIRES, INTERVIEWS, AND BIOMARKER MEASURES, SUCH AS CORTISOL IN SALIVA AND FECAL MICROBIOTA, WILL BE USED. THE PRIMARY OUTCOME IS THE PROPORTION OF GIRLS IN EACH GROUP WITH REDUCED PAIN, AS MEASURED BY THE FACES PAIN SCALE-REVISED IN A PAIN DIARY, IMMEDIATELY AFTER THE INTERVENTION. SECONDARY OUTCOMES ARE GASTROINTESTINAL SYMPTOMS, GENERAL HEALTH, MENTAL HEALTH, STRESS, AND PHYSICAL ACTIVITY. THE STUDY ALSO INCLUDES QUALITATIVE EVALUATIONS AND HEALTH ECONOMIC ANALYSES. THIS STUDY WAS APPROVED BY THE REGIONAL ETHICAL REVIEW BOARD IN UPPSALA (NO. 2016/082 1-2). RESULTS: DATA COLLECTION BEGAN IN OCTOBER 2016. THE INTERVENTION HAS BEEN PERFORMED IN 3 PERIODS FROM 2016 THROUGH 2019. THE FINAL 5-YEAR FOLLOW-UP IS ANTICIPATED TO BE COMPLETED BY FALL 2023. CONCLUSIONS: COST-EFFECTIVE AND EASILY ACCESSIBLE INTERVENTIONS ARE WARRANTED TO REDUCE THE NEGATIVE CONSEQUENCES ARISING FROM FAPDS IN YOUNG GIRLS. PHYSICAL ACTIVITY IS AN EFFECTIVE STRATEGY, BUT INTERVENTION STUDIES ARE NEEDED TO BETTER UNDERSTAND WHAT TYPES OF ACTIVITIES FACILITATE REGULAR PARTICIPATION IN THIS TARGET GROUP. THE JUST IN TIME (TRY, IDENTIFY, MOVE, AND ENJOY) STUDY WILL PROVIDE INSIGHTS REGARDING THE EFFECTIVENESS OF DANCE AND YOGA AND IS ANTICIPATED TO CONTRIBUTE TO THE CHALLENGING WORK OF REDUCING THE BURDEN OF FAPDS FOR YOUNG GIRLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV (NCT02920268); HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT02920268. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19748.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
2 2039  67 TESTING THE EFFICACY OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION: DESIGN AND METHODS OF THE BREATHEASY TRIAL. INTRODUCTION: SMOKERS TRYING TO QUIT ENCOUNTER MANY CHALLENGES INCLUDING NICOTINE WITHDRAWAL SYMPTOMS, CIGARETTE CRAVING, INCREASED STRESS AND NEGATIVE MOOD AND CONCERN REGARDING WEIGHT GAIN. THESE PHENOMENA MAKE IT DIFFICULT TO SUCCESSFULLY QUIT SMOKING. STUDIES IN NON-SMOKING POPULATIONS SHOW THAT YOGA REDUCES STRESS AND NEGATIVE MOOD AND IMPROVES WEIGHT CONTROL. BY INCREASING MINDFULNESS WE ANTICIPATE THAT YOGA MAY ALSO IMPROVE SMOKERS' ABILITY TO COPE WITH THE NEGATIVE SYMPTOMS ASSOCIATED WITH QUITTING. YOGA MAY ALSO IMPROVE COGNITIVE DELIBERATION WHICH IS NEEDED TO MAKE EFFECTIVE CHOICES AND AVOID SMOKING IN TEMPTING SITUATIONS. METHODS/DESIGN: THE BREATHEASY STUDY IS A RIGOROUS, RANDOMIZED CONTROLLED CLINICAL TRIAL EXAMINING THE EFFICACY OF IYENGAR YOGA AS A COMPLEMENTARY THERAPY TO COGNITIVE-BEHAVIORAL THERAPY FOR SMOKING CESSATION. ALL PARTICIPANTS ARE GIVEN AN 8-WEEK PROGRAM OF SMOKING CESSATION CLASSES, AND ARE RANDOMIZED TO EITHER TWICE WEEKLY YOGA (YOGA) OR TWICE-WEEKLY HEALTH AND WELLNESS CLASSES WHICH SERVE AS A CONTROL FOR CONTACT AND PARTICIPANT BURDEN (CTL). ASSESSMENTS ARE CONDUCTED AT BASELINE, 8 WEEKS, 3, 6, AND 12 MONTHS OF FOLLOW-UP. THE PRIMARY OUTCOME IS PROLONGED ABSTINENCE USING AN INTENTION-TO-TREAT APPROACH. MULTIPLE INTERNAL AND EXTERNAL AUDITS USING BLIND DATA COLLECTION ARE EMPLOYED TO ENSURE TREATMENT FIDELITY AND RELIABILITY OF STUDY RESULTS. TO UNDERSTAND WHY YOGA MAY BE MORE EFFECTIVE THAN CTL, WE WILL EXAMINE THE MECHANISMS OF ACTION (I.E., MEDIATORS) UNDERLYING INTERVENTION EFFICACY. WE WILL EXAMINE THE MAINTENANCE OF YOGA PRACTICE AND SMOKING STATUS AT EACH FOLLOW-UP. FOCUS GROUPS AND INTERVIEWS WILL BE USED TO ENRICH OUR UNDERSTANDING OF THE RELATIONSHIP OF YOGA PRACTICE AND SMOKING ABSTINENCE. CONCLUSIONS: THIS STUDY WILL PROVIDE A STRINGENT TEST OF THE RELATIVE EFFICACY OF YOGA COMPARED TO A CONDITION THAT CONTROLS FOR CONTACT TIME AND ATTENTION. THE USE OF MIXED METHODOLOGY ALSO PROVIDES THE OPPORTUNITY TO VALIDATE EXISTING KNOWLEDGE ABOUT YOGA AND HELPS TO EXPLORE NEW THEMES FOR FUTURE MINDFULNESS AND YOGA RESEARCH.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
3 1941  69 SAFETY AND EFFICACY OF AYURVEDIC INTERVENTIONS AND YOGA ON LONG TERM EFFECTS OF COVID-19: A STRUCTURED SUMMARY OF A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: PRIMARY OBJECTIVE * TO ASSESS THE EFFICACY OF AYURVEDA INTERVENTIONS AND YOGA IN REHABILITATION OF COVID-19 CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 AS COMPARED TO WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19- RELATED ILLNESS. SECONDARY OBJECTIVE * TO ASSESS THE SAFETY OF AYURVEDIC INTERVENTIONS IN CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 TRIAL DESIGN: MULTI-CENTRIC, RANDOMIZED, CONTROLLED, PARALLEL GROUP, OPEN-LABEL, EXPLORATORY STUDY. THE STUDY DURATION IS 9 MONTHS AND THE INTERVENTION PERIOD IS 90 DAYS FROM THE DAY OF ENROLMENT OF THE PARTICIPANT. PARTICIPANTS: PATIENTS OF EITHER SEX BETWEEN 18 TO 60 YEARS, AMBULATORY, WILLING TO PARTICIPATE, WITH HISTORY (NOT MORE THAN 4 WEEKS) OF POSITIVE RT-PCR FOR COVID-19 OR IGM ANTIBODIES POSITIVITY FOR SARS COV-2, BUT HAVING NEGATIVE RT-PCR FOR COVID-19 AT THE TIME OF SCREENING WILL BE CONSIDERED ELIGIBLE FOR ENROLMENT IN THE STUDY. CRITICALLY ILL PATIENTS WITH ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME), REQUIRING INVASIVE RESPIRATORY SUPPORT IN THE INTENSIVE CARE UNIT, KNOWN CASE OF ANY MALIGNANCY, IMMUNE-COMPROMISED STATE (E.G. HIV), DIABETES MELLITUS, ACTIVE PULMONARY TUBERCULOSIS, PAST HISTORY OF ANY CHRONIC RESPIRATORY DISEASE, MOTOR NEURON DISEASE, MULTIPLE SCLEROSIS, STROKE, IMPAIRED COGNITION, ATRIAL FIBRILLATION, ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, SEVERE ARRHYTHMIA, CONCURRENT SERIOUS HEPATIC DISEASE OR RENAL DISEASE, PREGNANT OR LACTATING WOMEN, PATIENTS ON IMMUNOSUPPRESSIVE MEDICATIONS, HISTORY OF HYPERSENSITIVITY TO THE TRIAL DRUGS OR THEIR INGREDIENTS, DEPRESSIVE ILLNESS (BEFORE COVID-19), DIAGNOSED PSYCHOTIC ILLNESSES, SUBSTANCE DEPENDENCE OR ALCOHOLISM WILL BE EXCLUDED. THE TRIAL WILL BE CONDUCTED AT TWO MEDICAL COLLEGES IN MAHARASHTRA, INDIA. INTERVENTION AND COMPARATOR: INTERVENTION ARM (GROUP-I): AYURVEDA INTERVENTIONS INCLUDING AGASTYA HARITAKI SIX GRAM AND ASHWAGANDHA TABLET 500 MG TWICE DAILY ORALLY AFTER MEALS WITH WARM WATER AND TWO SESSIONS OF YOGA (MORNING 30 MINUTES AND EVENING 15 MINUTES) DAILY FOR 90 DAYS, AS PER THE POST-COVID-19 CARE PROTOCOL PROVIDED IN NATIONAL CLINICAL MANAGEMENT PROTOCOL BASED ON AYURVEDA AND YOGA FOR MANAGEMENT OF COVID-19 PUBLISHED BY MINISTRY OF AYUSH, GOVERNMENT OF INDIA. COMPARATOR ARM (GROUP-II): WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19 RELATED ILLNESS FOR 90 DAYS. THE TRIAL DRUGS ARE BEING PROCURED FROM A GMP CERTIFIED PHARMACEUTICAL COMPANY. MAIN OUTCOMES: PRIMARY OUTCOME: CHANGE IN RESPIRATORY FUNCTION TO BE ASSESSED BY SAN DIEGO SHORTNESS OF BREATH QUESTIONNAIRE, 6-MINUTES WALK TEST AND PULMONARY FUNCTION TEST. SECONDARY OUTCOMES: CHANGE IN HIGH-RESOLUTION COMPUTED TOMOGRAPHY (HRCT) CHEST CHANGE IN FATIGUE SCORE ASSESSED BY MODIFIED FATIGUE IMPACT SCALE CHANGE IN ANXIETY SCORE ASSESSED BY HOSPITAL ANXIETY AND DEPRESSION SCALE SCORE CHANGE IN SLEEP QUALITY ASSESSED BY PITTSBURGH SLEEP QUALITY INDEX CHANGE IN THE QUALITY OF LIFE ASSESSED BY COV19-QOL SCALE SAFETY OF THE INTERVENTIONS WILL BE ASSESSED BY COMPARING HEMATOLOGICAL AND BIOCHEMICAL INVESTIGATIONS BEFORE AND AFTER THE INTERVENTION PERIOD AND ADVERSE EVENT/ ADVERSE DRUG REACTION TIMELINES FOR OUTCOME ASSESSMENT: SUBJECTIVE PARAMETERS AND CLINICAL ASSESSMENT WILL BE ASSESSED AT BASELINE, 15(TH) DAY, 30(TH) DAY, 60(TH) DAY AND 90(TH) DAY. LABORATORY PARAMETERS (CBC, LFT, KFT, HBA1C, HS-CRP, D-DIMER), PULMONARY FUNCTION TEST AND HRCT CHEST WILL BE DONE AT BASELINE AND AFTER COMPLETION OF STUDY PERIOD I.E. 90(TH) DAY. RANDOMISATION: STATISTICAL PACKAGE FOR SOCIAL SCIENCES (SPSS) VERSION 15.0 IS USED TO GENERATE THE RANDOM NUMBER SEQUENCES. THE PARTICIPANTS WILL BE RANDOMIZED TO TWO STUDY GROUPS IN THE RATIO OF 1:1. BLINDING (MASKING): THE STUDY IS OPEN-LABEL DESIGN. HOWEVER, THE OUTCOME ASSESSOR WILL BE KEPT BLINDED REGARDING THE STUDY GROUP ALLOCATION OF THE PARTICIPANTS. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: THE SAMPLE SIZE FOR THE STUDY IS CALCULATED ASSUMING IMPROVEMENT IN 6-MINUTES WALK TEST BY 40 METER IN GROUP I AND A CHANGE OF 10 METER IN GROUP II WITH A STANDARD DEVIATION OF 50 METER BASED ON THE RESULTS OF THE PREVIOUS STUDIES, WITH 95% CONFIDENCE LEVEL (ALPHA = 0.05) AND 80% POWER AND EXPECTING A DROPOUT RATE OF 20%. THE NUMBER OF PARTICIPANTS TO BE ENROLLED IN THE STUDY SHOULD BE APPROXIMATELY 55 IN EACH GROUP. HENCE, A TOTAL OF 110 PARTICIPANTS WILL BE ENROLLED IN THE TRIAL AT EACH STUDY SITE. TRIAL STATUS: PARTICIPANTS' RECRUITMENT STARTED ON 1(ST) MAY 2021. ANTICIPATED END OF RECRUITMENT IS AUGUST 2021. PROTOCOL NUMBER: CCRAS-01 PROTOCOL VERSION NUMBER: 1.1, 13TH JANUARY 2021. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE CLINICAL TRIAL REGISTRY OF INDIA (CTRI) ON 03(RD) MARCH 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: THE FULL PROTOCOL IS ATTACHED AS AN ADDITIONAL FILE, ACCESSIBLE FROM THE JOURNAL WEBSITE (ADDITIONAL FILE 1). THIS COMMUNICATION SERVES AS A SUMMARY OF THE KEY ELEMENTS OF THE FULL PROTOCOL.	2021	

4 2344  43 USING A STANDARDIZED VINIYOGA PROTOCOL FOR LUNG CANCER SURVIVORS: A PILOT STUDY EXAMINING EFFECTS ON BREATHING EASE. ALTHOUGH LUNG CANCER IS PERCEIVED AS A DIRE DIAGNOSIS, INCREASES IN THE 5-YEAR SURVIVAL RATE OF INDIVIDUALS WITH NON-SMALL CELL LUNG CANCER (NSCLC) HAVE BEEN REPORTED. SURVIVORS, HOWEVER, CONTINUE TO BE EXCESSIVELY BURDENED WITH SYMPTOMS SUCH AS RESPIRATORY DISTRESS WHICH INTERFERE WITH FUNCTIONING AND QUALITY OF LIFE. WHILE EXERCISE AND PHYSICAL ACTIVITY ARE STRONGLY RECOMMENDED, NSCLC SURVIVORS MAY BE RELUCTANT TO PARTICIPATE DUE TO ACTUAL OR ANTICIPATED SHORTNESS OF BREATH EXACERBATED WITH MOVEMENT.THIS QUASI-EXPERIMENTAL, INTERVENTION-ONLY PILOT STUDY AIMED TO DETERMINE THE EFFECTS OF AN 8-WEEK STANDARDIZED YOGA PROTOCOL FOR STAGE I-IIIA NSCLC SURVIVORS (N=9). THE PROTOCOL WAS DEVELOPED WITHIN THE VINIYOGA (HATHA) TRADITION WITH RESPIRATORY EXPERTS. BREATHING EASE, DYSPNEA, OXYGEN SATURATION, AND RESPIRATORY FUNCTION WERE EXPLORED IN RELATIONSHIP TO YOGA PRACTICE (45-MINUTE SESSIONS ONCE PER WEEK AND HOME PRACTICE) USING REPEATED-MEASURES ANALYSIS. NUMBER OF PARTICIPANTS REPORTING DYSPNEA RANGED FROM 25 TO 50% PRIOR TO PRACTICE WITH NO SIGNIFICANT INCREASE DURING SESSIONS, AND MODERATE DECREASES NOTED AT TIMES. OXYGEN SATURATION REMAINED HIGH AND VITAL SIGNS STABLE; FORCED EXPIRATORY VOLUME IN 1 SECOND (FEV1) VALUES INCREASED SIGNIFICANTLY OVER THE 14-WEEK STUDY PERIOD (P<0.0001). YOGA, WITH AN EMPHASIS ON POSTURES COORDINATED WITH BREATHING AND MEDITATION PRACTICES, OFFERS A POTENTIALLY FEASIBLE AND BENEFICIAL OPTION THAT REQUIRES FURTHER STUDY IN THIS POPULATION.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
5 2843  46 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
6  888  76 EFFECT OF YOGA VERSUS LIGHT EXERCISE TO IMPROVE WELL-BEING AND PROMOTE HEALTHY AGING AMONG OLDER ADULTS IN CENTRAL INDIA: A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: AGING IS A NATURAL PROCESS ASSOCIATED WITH MANY FUNCTIONAL AND STRUCTURAL CHANGES. THESE CHANGES MAY INCLUDE IMPAIRED SELF-REGULATION, CHANGES IN TISSUES AND ORGANS. AGING ALSO AFFECTS MOOD, PHYSICAL STATUS AND SOCIAL ACTIVITY. THERE ARE ADVERSE CHANGES IN COGNITIVE BEHAVIOR, PERCEIVED SENSATION AND THINKING PROCESSES. REGULAR PHYSICAL ACTIVITY CAN ALLEVIATE MANY HEALTH PROBLEMS; YET, MANY OLDER ADULTS ARE INACTIVE. YOGA IS ONE OF THE SCIENTIFIC AND POPULAR LIFESTYLE PRACTICE CONSIDERED AS THE INTEGRATION OF MIND, BODY AND SOUL. RESULTS OF PREVIOUS STUDIES REPORTED POSITIVE EFFECTS OF YOGA ON MULTIPLE HEALTH OUTCOMES IN ELDERLY. HOWEVER, THERE IS SCARCITY OF SCIENTIFIC INFORMATION WHERE YOGA'S EFFECT IS EXAMINED ON OVER WELL-BEING AND ON MULTIPLE HEALTH OUTCOMES SIMULTANEOUSLY IN ELDERLY. THIS PROTOCOL DESCRIBES METHODS FOR A 12-WEEK YOGA-BASED INTERVENTION EXPLORING THE EFFECTS OF YOGA ON WELL-BEING IN PHYSICALLY INACTIVE ELDERLY LIVING IN COMMUNITY. METHODS AND ANALYSIS: THIS TWO GROUP PARALLEL SINGLE BLIND RANDOMIZED CONTROLLED TRIAL THAT WILL BE CONDUCTED AT A DESIGNATED FACILITY OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, MADHYA PRADESH, CENTRAL INDIA. A 12-WEEK 60-MIN YOGA INTERVENTION THREE TIMES WEEKLY IS DESIGNED. COMPARISON GROUP PARTICIPANTS WILL UNDERGO A 60-MIN PROGRAM COMPRISING LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING TO IMPROVE MOBILITY. AFTER SCREENING, 144 PARTICIPANTS AGED 60-80 YEARS WILL BE RECRUITED. THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE MOBILITY, FALL RISK, COGNITION, ANXIETY AND DEPRESSION, MOOD AND STRESS, SLEEP QUALITY, PAIN, PHYSICAL ACTIVITY/SEDENTARY BEHAVIOR AND CARDIO-METABOLIC RISK FACTORS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE (0 WEEK), AFTER THE INTERVENTION (12+1 WEEK) AND AT FOLLOW-UP (36+1 WEEK). INTENTION-TO-TREAT ANALYSES WITH MIXED LINEAR MODELING WILL BE APPLIED. DISCUSSION: THROUGH THIS TRIAL, WE AIM TO DETERMINE WHETHER ELDERLY PEOPLE IN THE INTERVENTION GROUP PRACTICING YOGA SHOW MORE FAVORABLE PRIMARY (WELL-BEING) AND SECONDARY OUTCOMES THAN THOSE IN THE LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING GROUP. WE ASSUME THAT YOGA MAY BE PRACTICED TO MAINTAIN HEALTH, REDUCE PARTICULAR SYMPTOMS COMMONLY ASSOCIATED WITH SKELETAL PAIN, ASSIST IN PAIN RELIEF AND ENHANCE WELL-BEING. WE ANTICIPATE THAT PRACTICING YOGA WILL IMPROVE WELL-BEING AND MENTAL HEALTH AND MAY LEAD TO SIGNIFICANT IMPROVEMENT IN DEPRESSION, PAIN AND SLEEP QUALITY.ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, IEC REF NO. 09/2018. ALL PARTICIPANTS WOULD BE PROVIDED WITH WRITTEN AND VERBAL INFORMATION ABOUT THE PURPOSE OF THE PROJECT AND WOULD BE FREE TO WITHDRAW FROM THE STUDY AT ANY TIME. REFUSAL TO PARTICIPATE IN THE STUDY WOULD NOT HAVE ANY NEGATIVE CONSEQUENCES. CONFIDENTIALITY OF THE INFORMATION OF EACH PARTICIPANT WOULD BE ENSURED. KNOWLEDGE OBTAINED WOULD BE DISSEMINATED TO STAKEHOLDERS THROUGH WORKSHOPS, MEETINGS AND RELEVANT SCIENTIFIC CONFERENCES. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE INDIAN COUNCIL OF MEDICAL RESEARCH TRIAL REGISTRY CTRI/2018/07/015051.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
7  566  82 DANCE AND YOGA REDUCED FUNCTIONAL ABDOMINAL PAIN IN YOUNG GIRLS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: FUNCTIONAL ABDOMINAL PAIN DISORDERS (FAPDS) AFFECT CHILDREN, ESPECIALLY GIRLS, ALL OVER THE WORLD. THE EVIDENCE FOR EXISTING TREATMENTS IS MIXED, AND EFFECTIVE ACCESSIBLE TREATMENTS ARE NEEDED. DANCE, A RHYTHMIC CARDIO-RESPIRATORY ACTIVITY, COMBINED WITH YOGA, WHICH ENHANCES RELAXATION AND FOCUS, MAY PROVIDE PHYSIOLOGICAL AND PSYCHOLOGICAL BENEFITS THAT COULD HELP TO EASE PAIN. OBJECTIVES: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF A DANCE AND YOGA INTERVENTION ON MAXIMUM ABDOMINAL PAIN IN 9- TO 13-YEAR- OLD GIRLS WITH FAPDS. METHODS: THIS STUDY WAS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL WITH 121 PARTICIPANTS RECRUITED FROM OUTPATIENT CLINICS AS WELL AS THE GENERAL PUBLIC. THE INTERVENTION GROUP PARTICIPATED IN DANCE AND YOGA TWICE WEEKLY FOR 8 MONTHS; CONTROLS RECEIVED STANDARD CARE. ABDOMINAL PAIN, AS SCORED ON THE FACES PAIN SCALE-REVISED, WAS RECORDED IN A PAIN DIARY. A LINEAR MIXED MODEL WAS USED TO ESTIMATE THE OUTCOMES AND EFFECT SIZES. RESULTS: DANCE AND YOGA WERE SUPERIOR TO STANDARD HEALTH CARE ALONE, WITH A MEDIUM TO HIGH BETWEEN-GROUP EFFECT SIZE AND SIGNIFICANTLY GREATER PAIN REDUCTION (B = -1.29, P = 0.002) AT THE END OF THE INTERVENTION. CONCLUSIONS: AN INTERVENTION USING DANCE AND YOGA IS LIKELY A FEASIBLE AND BENEFICIAL COMPLEMENTARY TREATMENT TO STANDARD HEALTH CARE FOR 9- TO 13-YEAR-OLD GIRLS WITH FAPDS. SIGNIFICANCE: FAPDS AFFECT CHILDREN, ESPECIALLY GIRLS, ALL OVER THE WORLD. THE NEGATIVE CONSEQUENCES SUCH AS ABSENCE FROM SCHOOL, HIGH CONSUMPTION OF MEDICAL CARE AND DEPRESSION POSE A CONSIDERABLE BURDEN ON CHILDREN AND THEIR FAMILIES AND EFFECTIVE TREATMENTS ARE NEEDED. THIS IS THE FIRST STUDY EXAMINING A COMBINED DANCE/YOGA INTERVENTION FOR YOUNG GIRLS WITH FAPDS AND THE RESULT SHOWED A REDUCTION OF ABDOMINAL PAIN. THESE FINDINGS CONTRIBUTE WITH NEW EVIDENCE IN THE FIELD OF MANAGING FAPDS IN A VULNERABLE TARGET GROUP.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
8 2831  57 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
9 2638  60 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
10 2389  83 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
11 1165  80 EVALUATING THE FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES IN PEOPLE LIVING WITH HIV: PROTOCOL FOR A RANDOMIZED PILOT TRIAL. BACKGROUND: DESPITE LOWER MORTALITY RATES DUE TO COMBINATION ANTIRETROVIRAL THERAPY, PEOPLE LIVING WITH HIV (PLWH) ARE GRAPPLING WITH INCREASINGLY COMPLEX HEALTH ISSUES, INCLUDING COGNITIVE IMPAIRMENTS IN AREAS SUCH AS MEMORY, ATTENTION, PROCESSING SPEED, AND MOTOR FUNCTION. YOGA HAS BEEN SHOWN TO BE AN EFFECTIVE FORM OF EXERCISE AND MINDFULNESS-BASED STRESS REDUCTION FOR MANY CLINICAL POPULATIONS. HOWEVER, NO RANDOMIZED TRIALS HAVE EVALUATED THE IMPACT OF YOGA ON COGNITIVE AND PHYSICAL FUNCTION AMONG PLWH. OBJECTIVE: THE AIM OF THIS PILOT RANDOMIZED TRIAL WAS TO DETERMINE THE FEASIBILITY OF A YOGA INTERVENTION TO LAY THE GROUNDWORK FOR A FULL-SCALE, MULTISITE, COMMUNITY-BASED TRIAL FOR PLWH. SPECIFIC OBJECTIVES ARE TO (1) ASSESS THE FEASIBILITY OF STUDY PROTOCOL AND PROCEDURES, (2) COMPARE COGNITION IN THE YOGA GROUP WITH THE USUAL CARE CONTROL GROUP AFTER 12 WEEKS OF THE INTERVENTION IN PLWH, AND (3) COMPARE THE EFFECTS OF THE 12-WEEK YOGA INTERVENTION VERSUS CONTROL ON BALANCE, WALKING SPEED, PHYSICAL ACTIVITY, MENTAL HEALTH, MEDICATION ADHERENCE, AND QUALITY OF LIFE AMONG PLWH. METHODS: WE PROPOSE A PILOT RANDOMIZED TRIAL WITH 2 PARALLEL GROUPS (YOGA VERSUS CONTROL). WE WILL RECRUIT 25 PLWH (>35 YEARS) FROM COMMUNITY AND HEALTH ORGANIZATIONS IN HALIFAX, CANADA. AFTER BASELINE ASSESSMENT WITH BLINDED ASSESSORS, PARTICIPANTS WILL BE RANDOMLY ASSIGNED TO THE YOGA OR CONTROL GROUP, USING A RANDOM COMPUTER GENERATOR. PARTICIPANTS IN THE YOGA GROUP WILL ENGAGE IN SUPERVISED 60-MIN GROUP-BASED YOGA SESSIONS 3 TIMES A WEEK FOR 12 WEEKS AT A YOGA STUDIO. PARTICIPANTS IN THE CONTROL GROUP WILL MAINTAIN THEIR CURRENT PHYSICAL ACTIVITY LEVELS THROUGHOUT THE STUDY. RESULTS: AS PER THE CONSOLIDATED STANDARDS OF REPORTING TRIALS EXTENSION FOR PILOT STUDIES, MEANS OF ALL OUTCOMES, MEAN CHANGE, AND 95% CIS WILL BE CALCULATED FOR EACH GROUP SEPARATELY. TWO-TAILED INDEPENDENT T TESTS AND FISHER EXACT TESTS WILL BE USED TO COMPARE GROUPS AT BASELINE. WE WILL ANALYZE QUANTITATIVE POSTINTERVENTION QUESTIONNAIRE RESPONSES USING CHI-SQUARE TESTS, AND OPEN-ENDED RESPONSES WILL BE ANALYZED THEMATICALLY. INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSES WILL BE USED TO ANALYZE SECONDARY VARIABLES. CHANGES IN OUTCOME VARIABLES WILL BE EXAMINED BETWEEN GROUPS AND WITHIN GROUPS. EFFECT SIZES WILL BE REPORTED FOR EACH OUTCOME. A PRIORI ADHERENCE AND SATISFACTION CRITERIA WILL BE MET IF PARTICIPANTS ATTEND >70% OF THE YOGA SESSIONS AND IF >70% OF THE PARTICIPANTS ARE SATISFIED WITH THE INTERVENTION AS DETERMINED BY A POSTPARTICIPATION QUESTIONNAIRE. STUDY ENROLLMENT BEGAN IN JANUARY 2018, WITH RESULTS EXPECTED FOR OCTOBER 2019. CONCLUSIONS: THIS PILOT RANDOMIZED TRIAL WILL BE THE FIRST TO INVESTIGATE THE FEASIBILITY AND EFFECT OF A YOGA INTERVENTION ON COGNITIVE AND PHYSICAL OUTCOMES AMONG PLWH. THIS WORK WILL INFORM THE FEASIBILITY OF FURTHER INVESTIGATIONS IN TERMS OF CAPACITY BUILDING, PARTICIPANT RECRUITMENT AND RETENTION, AND ASSESSMENT AND INTERVENTION PROTOCOLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03071562; HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03071562 (ARCHIVED BY WEBCITE AT HTTP://WWW.WEBCITATION.ORG/785SFHWKW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13818.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
12 1093  64 EFFECTS OF YOGA ON WELL-BEING AND HEALTHY AGEING: STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (FITFORAGE). INTRODUCTION: DUE TO AGEING POPULATIONS WORLDWIDE, THE BURDEN OF DISABILITY IS INCREASING. IT IS THEREFORE IMPORTANT TO DEVELOP INTERVENTIONS THAT IMPROVE HEALTHY AGEING, REDUCE DISABILITY ONSET AND ENHANCE LIFE QUALITY. PHYSICAL ACTIVITY CAN PROMOTE HEALTHY AGEING AND HELP MAINTAIN INDEPENDENCE, YET MANY OLDER ADULTS ARE INACTIVE. YOGA IS A FORM OF PHYSICAL ACTIVITY THAT AIMS TO IMPROVE HEALTH AND MAY BE PARTICULARLY SUITABLE FOR OLDER ADULTS. RESEARCH INDICATES POSITIVE EFFECTS OF YOGA ON SEVERAL HEALTH-RELATED OUTCOMES; HOWEVER, EMPIRICAL STUDIES EXAMINING THE BENEFITS OF YOGA ON WELL-BEING AMONG THE ELDERLY REMAIN SCARCE. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 12-WEEK YOGA PROGRAMME AIMED TO IMPROVE HEALTH AND WELL-BEING AMONG PHYSICALLY INACTIVE OLDER ADULTS. METHODS AND ANALYSIS: THREE GROUP PARALLEL, SINGLE-BLIND RANDOMISED CONTROLLED TRIAL. TWO COMPARISON GROUPS ARE INCLUDED: AEROBIC EXERCISE AND A NON-ACTIVE WAIT-LIST CONTROL. IN TOTAL, 180 PARTICIPANTS AGED 65-85 YEARS WILL BE RECRUITED. ASSESSMENTS WILL BE PERFORMED AT BASELINE AND POSTINTERVENTION (12-WEEK FOLLOW-UP). THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE PHYSICAL ACTIVITY/SEDENTARY BEHAVIOUR, MOBILITY/FALL RISK, COGNITION, DEPRESSION, ANXIETY, MOOD, STRESS, PAIN, SLEEP QUALITY, SOCIAL SUPPORT AND CARDIOMETABOLIC RISK FACTORS. DATA WILL BE ANALYSED USING INTENTION-TO-TREAT ANALYSES, WITH MIXED LINEAR MODELLING. ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE ETHICAL REVIEW BOARD IN STOCKHOLM (2017/1862-31/2). ALL PARTICIPANTS MUST VOLUNTARILY AGREE TO PARTICIPATE AND ARE FREE TO WITHDRAW FROM THE STUDY AT ANY POINT. WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. A SUMMARY OF KEY RESULTS WILL BE PUBLICLY AVAILABLE THROUGH NEWSPAPER ARTICLES. TRIAL REGISTRATION NUMBER: DRKS00015093, U1111-1217-4248.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
13  175  58 A RANDOMIZED CONTROLLED TRIAL EXAMINING IYENGAR YOGA FOR YOUNG ADULTS WITH RHEUMATOID ARTHRITIS: A STUDY PROTOCOL. BACKGROUND: RHEUMATOID ARTHRITIS IS A CHRONIC, DISABLING DISEASE THAT CAN COMPROMISE MOBILITY, DAILY FUNCTIONING, AND HEALTH-RELATED QUALITY OF LIFE, ESPECIALLY IN OLDER ADOLESCENTS AND YOUNG ADULTS. IN THIS PROJECT, WE WILL COMPARE A STANDARDIZED IYENGAR YOGA PROGRAM FOR YOUNG PEOPLE WITH RHEUMATOID ARTHRITIS TO A STANDARD CARE WAIT-LIST CONTROL CONDITION. METHODS/DESIGN: SEVENTY RHEUMATOID ARTHRITIS PATIENTS AGED 16-35 YEARS WILL BE RANDOMIZED INTO EITHER THE 6-WEEK IYENGAR YOGA PROGRAM (12 - 1.5 HOUR SESSIONS TWICE WEEKLY) OR THE 6-WEEK WAIT-LIST CONTROL CONDITION. A 20% ATTRITION RATE IS ANTICIPATED. THE WAIT-LIST GROUP WILL RECEIVE THE YOGA PROGRAM FOLLOWING COMPLETION OF THE FIRST ARM OF THE STUDY. WE WILL COLLECT DATA QUANTITATIVELY, USING QUESTIONNAIRES AND MARKERS OF DISEASE ACTIVITY, AND QUALITATIVELY USING SEMI-STRUCTURED INTERVIEWS. ASSESSMENTS INCLUDE STANDARDIZED MEASURES OF GENERAL AND ARTHRITIS-SPECIFIC FUNCTION, PAIN, MOOD, AND HEALTH-RELATED QUALITY OF LIFE, AS WELL AS QUALITATIVE INTERVIEWS, BLOOD PRESSURE/RESTING HEART RATE MEASUREMENTS, A MEDICAL EXAM AND THE ASSESSMENT OF PRO-INFLAMMATORY CYTOKINES. DATA WILL BE COLLECTED THREE TIMES: BEFORE TREATMENT, POST-TREATMENT, AND TWO MONTHS FOLLOWING THE TREATMENT. DISCUSSION: RESULTS FROM THIS STUDY WILL PROVIDE CRITICAL DATA ON NON-PHARMACOLOGIC METHODS FOR ENHANCING FUNCTION IN RHEUMATOID ARTHRITIS PATIENTS. IN PARTICULAR, RESULTS WILL SHED LIGHT ON THE FEASIBILITY AND POTENTIAL EFFICACY OF A NOVEL INTERVENTION FOR RHEUMATOID ARTHRITIS SYMPTOMS, PAVING THE WAY FOR A LARGER CLINICAL TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01096823.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
14  975  41 EFFECTS OF AN INTEGRATED YOGA PROGRAMME ON CHEMOTHERAPY-INDUCED NAUSEA AND EMESIS IN BREAST CANCER PATIENTS. THIS STUDY EXAMINED THE EFFECT OF AN INTEGRATED YOGA PROGRAMME ON CHEMOTHERAPY-RELATED NAUSEA AND EMESIS IN EARLY OPERABLE BREAST CANCER OUTPATIENTS. SIXTY-TWO SUBJECTS WERE RANDOMLY ALLOCATED TO RECEIVE YOGA (N = 28) OR SUPPORTIVE THERAPY INTERVENTION (N = 34) DURING THE COURSE OF THEIR CHEMOTHERAPY. BOTH GROUPS HAD SIMILAR SOCIO-DEMOGRAPHIC AND MEDICAL CHARACTERISTICS. INTERVENTION CONSISTED OF BOTH SUPERVISED AND HOME PRACTICE OF YOGA SESSIONS LASTING FOR 60 MIN DAILY, WHILE THE CONTROL GROUP RECEIVED SUPPORTIVE THERAPY AND COPING PREPARATION DURING THEIR HOSPITAL VISITS OVER A COMPLETE COURSE OF CHEMOTHERAPY. THE PRIMARY OUTCOME MEASURE WAS THE MORROW ASSESSMENT OF NAUSEA AND EMESIS (MANE) ASSESSED AFTER THE FOURTH CYCLE OF CHEMOTHERAPY. SECONDARY OUTCOMES INCLUDED MEASURES FOR ANXIETY, DEPRESSION, QUALITY OF LIFE, DISTRESSFUL SYMPTOMS AND TREATMENT-RELATED TOXICITY ASSESSED BEFORE AND DURING THE COURSE OF CHEMOTHERAPY. FOLLOWING YOGA, THERE WAS A SIGNIFICANT DECREASE IN POST-CHEMOTHERAPY-INDUCED NAUSEA FREQUENCY (P = 0.01) AND NAUSEA INTENSITY (P = 0.01), AND INTENSITY OF ANTICIPATORY NAUSEA (P = 0.01) AND ANTICIPATORY VOMITING (P = 0.05) AS COMPARED WITH THE CONTROL GROUP. THERE WAS A SIGNIFICANT POSITIVE CORRELATION BETWEEN MANE SCORES AND ANXIETY, DEPRESSION AND DISTRESSFUL SYMPTOMS. IN CONCLUSION, THE RESULTS SUGGEST A POSSIBLE USE FOR STRESS REDUCTION INTERVENTIONS SUCH AS YOGA IN COMPLEMENTING CONVENTIONAL ANTIEMETICS TO MANAGE CHEMOTHERAPY-RELATED NAUSEA AND EMESIS.	2007	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
15 1215  62 EXPLORING THE EFFECTS OF YOGA THERAPY ON HEART RATE VARIABILITY AND PATIENT-REPORTED OUTCOMES AFTER CANCER TREATMENT: A STUDY PROTOCOL. BACKGROUND: FOLLOWING CANCER TREATMENT, ADULTS COMMONLY REPORT WORSENED PATIENT-REPORTED OUTCOMES (PROS) SUCH AS ANXIETY, STRESS, DEPRESSION, PERSISTENT AND UPSETTING COGNITIVE COMPLAINTS, UNRELENTING FATIGUE, AND REDUCED QUALITY OF LIFE. POORER PROS ARE ASSOCIATED WITH DISRUPTED AUTONOMIC NERVOUS SYSTEM FUNCTIONING AS MEASURED BY HEART RATE VARIABILITY (HRV), BOTH OF WHICH HAVE BEEN ASSOCIATED WITH GREATER MORBIDITY AND MORTALITY. INTERVENTIONS TO IMPROVE HRV AND PROS AMONG ADULTS FOLLOWING CANCER TREATMENT ARE NEEDED. YOGA THERAPY HOLDS PROMISE AS AN INTERVENTION TO IMPROVE HRV AND PROS. THEREFORE, WE CONDUCTED A SINGLE-SUBJECT EXPLORATORY EXPERIMENTAL STUDY TO INVESTIGATE THE EFFECTS OF YOGA THERAPY ON HRV AND SPECIFIC PROS (IE, CANCER-RELATED FATIGUE, ANXIETY, COGNITIVE FUNCTION, DEPRESSION, STRESS, QUALITY OF LIFE) IN ADULTS TREATED FOR CANCER. TO REDUCE PUBLICATION BIAS, IMPROVE REPRODUCIBILITY, AND SERVE AS A REFERENCE FOR FORTHCOMING REPORTING OF STUDY RESULTS, WE PRESENT THE STUDY PROTOCOL FOR THIS STUDY HEREIN. METHODS: PARTICIPANTS WERE ADULTS WHO COMPLETED CANCER TREATMENT THAT WERE RECRUITED FROM THE OTTAWA INTEGRATIVE CANCER CENTRE. CONSENTING AND ELIGIBLE PARTICIPANTS RECEIVED ONE 1:1 YOGA THERAPY SESSION (IE, 1 PARTICIPANT, 1 YOGA THERAPIST) AND 6 WEEKLY GROUP-BASED YOGA THERAPY SESSIONS (IE, 2-3 PARTICIPANTS, 1 YOGA THERAPIST). PARTICIPANTS COMPLETED ASSESSMENTS 7 TIMES: 3 TIMES PRIOR TO THE PROGRAM (IE, -6 WEEKS, -3 WEEKS, IMMEDIATELY PRIOR TO THE 1:1 YOGA THERAPY SESSION), IMMEDIATELY FOLLOWING THE 1:1 YOGA THERAPY SESSION, PRIOR TO THE FIRST GROUP-BASED YOGA THERAPY SESSION, AFTER THE LAST GROUP-BASED YOGA THERAPY SESSION, AND AT A 6-WEEK FOLLOW-UP. HIERARCHICAL LINEAR MODELING WILL BE USED TO TEST THE AVERAGE EFFECTS OF THE YOGA THERAPY PROGRAM ACROSS PARTICIPANTS. DISCUSSION: THIS STUDY WILL EXPLORE SEVERAL NOVEL HYPOTHESES, INCLUDING WHETHER YOGA THERAPY CAN IMPROVE HRV AND/OR SPECIFIC PROS AMONG ADULTS TREATED FOR CANCER ACUTELY (IE, DURING A 1:1 YOGA THERAPY SESSION) AND/OR THROUGH REPEATED EXPOSURE (IE, AFTER COMPLETING 6 WEEKS OF GROUP-BASED YOGA THERAPY). ALTHOUGH THE FINDINGS WILL REQUIRE CONFIRMATION OR REFUTATION IN FUTURE TRIALS, THEY MAY PROVIDE INITIAL EVIDENCE THAT YT MAY BENEFIT ADULTS TREATED FOR CANCER. TRIAL REGISTRATION: ISRCTN REGISTRY, ISRCTN64763228. REGISTERED ON DECEMBER 12, 2021. THIS TRIAL WAS REGISTERED RETROSPECTIVELY. URL OF TRIAL REGISTRY RECORD: HTTPS://WWW.ISRCTN.COM/ISRCTN64763228.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
16 2824  61 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
17 2577  55 YOGA FOR GENERALIZED ANXIETY DISORDER: DESIGN OF A RANDOMIZED CONTROLLED CLINICAL TRIAL. GENERALIZED ANXIETY DISORDER (GAD) IS A COMMON DISORDER ASSOCIATED WITH SIGNIFICANT DISTRESS AND INTERFERENCE. ALTHOUGH COGNITIVE BEHAVIORAL THERAPY (CBT) HAS BEEN SHOWN TO BE THE MOST EFFECTIVE FORM OF PSYCHOTHERAPY, FEW PATIENTS RECEIVE OR HAVE ACCESS TO THIS INTERVENTION. YOGA THERAPY OFFERS ANOTHER PROMISING, YET UNDER-RESEARCHED, INTERVENTION THAT IS GAINING INCREASING POPULARITY IN THE GENERAL PUBLIC, AS AN ANXIETY REDUCTION INTERVENTION. THE PURPOSE OF THIS INNOVATIVE CLINICAL TRIAL PROTOCOL IS TO INVESTIGATE THE EFFICACY OF A KUNDALINI YOGA INTERVENTION, RELATIVE TO CBT AND A CONTROL CONDITION. KUNDALINI YOGA AND CBT ARE COMPARED WITH EACH OTHER IN A NONINFERIORITY TEST AND BOTH TREATMENTS ARE COMPARED TO STRESS EDUCATION TRAINING, AN ATTENTION CONTROL INTERVENTION, IN SUPERIORITY TESTS. THE SAMPLE WILL CONSIST OF 230 INDIVIDUALS WITH A PRIMARY DSM-5 DIAGNOSIS OF GAD. THIS RANDOMIZED CONTROLLED TRIAL WILL COMPARE YOGA (N=95) TO BOTH CBT FOR GAD (N=95) AND STRESS EDUCATION (N=40), A COMMONLY USED CONTROL CONDITION. ALL THREE TREATMENTS WILL BE ADMINISTERED BY TWO INSTRUCTORS IN A GROUP FORMAT OVER 12 WEEKLY SESSIONS WITH FOUR TO SIX PATIENTS PER GROUP. GROUPS WILL BE RANDOMIZED USING PERMUTED BLOCK RANDOMIZATION, WHICH WILL BE STRATIFIED BY SITE. TREATMENT OUTCOME WILL BE EVALUATED BI-WEEKLY AND AT 6MONTH FOLLOW-UP. FURTHERMORE, POTENTIAL MEDIATORS OF TREATMENT OUTCOME WILL BE INVESTIGATED. GIVEN THE INDIVIDUAL AND ECONOMIC BURDEN ASSOCIATED WITH GAD, IDENTIFYING ACCESSIBLE ALTERNATIVE BEHAVIORAL TREATMENTS WILL HAVE SUBSTANTIVE PUBLIC HEALTH IMPLICATIONS.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
18 1617  66 MINDFUL YOGA FOR WOMEN WITH METASTATIC BREAST CANCER: DESIGN OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: WOMEN WITH METASTATIC BREAST CANCER (MBC) HAVE AVERAGE LIFE EXPECTANCIES OF ABOUT 2 YEARS, AND REPORT HIGH LEVELS OF DISEASE-RELATED SYMPTOMS INCLUDING PAIN, FATIGUE, SLEEP DISTURBANCE, PSYCHOLOGICAL DISTRESS, AND FUNCTIONAL IMPAIRMENT. THERE IS GROWING RECOGNITION OF THE LIMITATIONS OF MEDICAL APPROACHES TO MANAGING SUCH SYMPTOMS. YOGA IS A MIND-BODY DISCIPLINE THAT HAS DEMONSTRATED A POSITIVE IMPACT ON PSYCHOLOGICAL AND FUNCTIONAL HEALTH IN EARLY STAGE BREAST CANCER PATIENTS AND SURVIVORS, BUT HAS NOT BEEN RIGOROUSLY STUDIED IN ADVANCED CANCER SAMPLES. METHODS: THIS RANDOMIZED CONTROLLED TRIAL EXAMINES THE FEASIBILITY AND INITIAL EFFICACY OF A MINDFUL YOGA PROGRAM, COMPARED WITH A SOCIAL SUPPORT CONDITION THAT CONTROLS FOR ATTENTION, ON MEASURES OF DISEASE-RELATED SYMPTOMS SUCH AS PAIN AND FATIGUE. THE STUDY WILL BE COMPLETED BY DECEMBER 2017. SIXTY-FIVE WOMEN WITH MBC AGE >/= 18 ARE BEING IDENTIFIED AND RANDOMIZED WITH A 2:1 ALLOCATION TO MINDFUL YOGA OR A SUPPORT GROUP CONTROL INTERVENTION. THE 120-MIN INTERVENTION SESSIONS TAKE PLACE WEEKLY FOR 8 WEEKS. THE STUDY IS CONDUCTED AT AN URBAN TERTIARY CARE ACADEMIC MEDICAL CENTER LOCATED IN DURHAM, NORTH CAROLINA. THE PRIMARY FEASIBILITY OUTCOME IS ATTENDANCE AT INTERVENTION SESSIONS. EFFICACY OUTCOMES INCLUDE PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS AND FUNCTIONAL CAPACITY AT POST-INTERVENTION, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. DISCUSSION: IN THIS ARTICLE, WE PRESENT THE CHALLENGES OF DESIGNING A RANDOMIZED CONTROLLED TRIAL WITH LONG-TERM FOLLOW-UP AMONG WOMEN WITH MBC. THESE CHALLENGES INCLUDE ENSURING ADEQUATE RECRUITMENT INCLUDING OF MINORITIES, LIMITING AND CONTROLLING FOR SELECTION BIAS, TAILORING OF THE YOGA INTERVENTION TO ADDRESS SPECIAL NEEDS, AND MAXIMIZING ADHERENCE AND RETENTION. THIS PROJECT WILL PROVIDE IMPORTANT INFORMATION REGARDING YOGA AS AN INTERVENTION FOR WOMEN WITH ADVANCED CANCER, INCLUDING PRELIMINARY DATA ON THE PSYCHOLOGICAL AND FUNCTIONAL EFFECTS OF YOGA FOR MBC PATIENTS. THIS INVESTIGATION WILL ALSO ESTABLISH RIGOROUS METHODS FOR FUTURE RESEARCH INTO YOGA AS AN INTERVENTION FOR THIS POPULATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFER: NCT01927081 , REGISTERED AUGUST 16, 2013.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
19 1953  61 SECONDARY OUTCOMES FROM A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR VETERANS WITH CHRONIC LOW-BACK PAIN. CHRONIC LOW-BACK PAIN (CLBP) IS A PREVALENT CONDITION, AND RATES ARE HIGHER AMONG MILITARY VETERANS. CLBP IS A PERSISTENT CONDITION, AND TREATMENT OPTIONS HAVE EITHER MODEST EFFECTS OR A SIGNIFICANT RISK OF SIDE-EFFECTS, WHICH HAS LED TO RECENT EFFORTS TO EXPLORE MIND-BODY INTERVENTION OPTIONS AND REDUCE OPIOID MEDICATION USE. PRIOR STUDIES OF YOGA FOR CLBP IN COMMUNITY SAMPLES, AND THE MAIN RESULTS OF A RECENT TRIAL WITH MILITARY VETERANS, INDICATE THAT YOGA CAN REDUCE BACK-RELATED DISABILITY AND PAIN INTENSITY. SECONDARY OUTCOMES FROM THE TRIAL OF YOGA WITH MILITARY VETERANS ARE PRESENTED HERE. IN THE STUDY, 150 MILITARY VETERANS (VETERANS ADMINISTRATION PATIENTS) WITH CLBP WERE RANDOMIZED TO EITHER YOGA OR A DELAYED-TREATMENT GROUP RECEIVING USUAL CARE BETWEEN 2013 AND 2015. ASSESSMENTS OCCURRED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENT-TO-TREAT ANALYSES WERE CONDUCTED. YOGA CLASSES LASTING 60 MINUTES EACH WERE OFFERED TWICE WEEKLY FOR 12 WEEKS. YOGA SESSIONS CONSISTED OF PHYSICAL POSTURES, MOVEMENT, FOCUSED ATTENTION, AND BREATHING TECHNIQUES. HOME PRACTICE GUIDED BY A MANUAL WAS STRONGLY RECOMMENDED. THE PRIMARY OUTCOME MEASURE WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. SECONDARY OUTCOMES INCLUDED PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, FATIGUE, QUALITY OF LIFE, SELF-EFFICACY, AND MEDICATION USAGE. YOGA PARTICIPANTS IMPROVED MORE THAN DELAYED-TREATMENT PARTICIPANTS ON PAIN INTERFERENCE, FATIGUE, QUALITY OF LIFE, AND SELF-EFFICACY AT 12 WEEKS AND/OR 6 MONTHS. YOGA PARTICIPANTS HAD GREATER IMPROVEMENTS ACROSS A NUMBER OF IMPORTANT SECONDARY HEALTH OUTCOMES COMPARED TO CONTROLS. BENEFITS EMERGED DESPITE SOME VETERANS FACING CHALLENGES WITH ATTENDING YOGA SESSIONS IN PERSON. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS, WITH ATTENTION TO INCREASING ACCESSIBILITY OF YOGA PROGRAMS IN THIS POPULATION.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
20 1495  45 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE.	2016