1 1941 357 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 2 2843 45 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 3 258 62 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 4 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 5 2389 77 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 6 2036 62 TELE-YOGA IN LONG TERM ILLNESS-PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL INCLUDING A PROCESS EVALUATION AND RESULTS FROM A PILOT STUDY. BACKGROUND: FOR PEOPLE WITH LONG-TERM ILLNESS, DEBILITATED BY SEVERE SYMPTOMS, IT CAN BE DIFFICULT TO ATTEND REGULAR YOGA CLASSES. WE HAVE THEREFORE DEVELOPED A TELE-HEALTH FORMAT OF YOGA THAT CAN BE DELIVERED IN THE HOME. THE TELE-YOGA WAS CO-DESIGNED WITH MEMBERS OF A PATIENT-ORGANISATION, YOGA-INSTRUCTOR, AND IT-TECHNICIAN. IT INCLUDES LIVE-STREAMED GROUP-YOGA SESSIONS TWICE A WEEK AND AN APP WITH INSTRUCTIONS ON HOW TO SELF-PERFORM YOGA. AIM: TO DESCRIBE A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (RCT) INCLUDING A PROCESS EVALUATION AND REPORT ON A PILOT STUDY EVALUATING METHOD- AND INTERVENTION-RELATED COMPONENTS INCLUDING FEASIBILITY, SAFETY, AND EFFICACY. METHODS: TEN PARTICIPANTS WITH HEART FAILURE AGED BETWEEN 41-76 YEARS WERE RANDOMISED TO TELE-YOGA (N = 5) OR TO THE CONTROL GROUP (N = 5). IN THE PILOT STUDY RECRUITMENT, ENROLMENT, RANDOMISATION, AND DATA COLLECTION OF ALL OUTCOMES INCLUDING PRIMARY, SECONDARY AND PROCESS EVALUATION MEASURES WERE TESTED ACCORDING TO THE STUDY PROTOCOL. FIDELITY, ADHERENCE AND ACCEPTABILITY TO THE TELE-YOGA GROUP TRAINING AND APP USE WAS DETERMINED. SAFETY WAS ASSESSED BY ADVERSE EVENTS. RESULTS: THE PILOT REVEALED THAT THE METHODOLOGICAL ASPECT OF THE PROTOCOL WORKED SUFFICIENTLY IN ALL ASPECTS EXCEPT FOR MISSING DATA IN THE PHYSICAL TEST OF TWO PARTICIPANTS AND ONE PARTICIPANT IN THE CONTROL-GROUP THAT DROPPED OUT OF THE STUDY AT THREE MONTHS FOLLOW-UP. THE TELE-YOGA TRAINING DID NOT LEAD TO ANY ADVERSE EVENTS OR INJURIES, ADHERENCE OF TELE-YOGA WAS SUFFICIENT ACCORDING TO PRESET LIMITS. THE TELE-YOGA INTERVENTION ALSO SHOWED SOME FAVOURABLE TRENDS OF IMPROVEMENTS IN THE COMPOSITE-END POINT COMPARED TO THE ACTIVE CONTROL GROUP. HOWEVER, SINCE DATA ONLY WAS PRESENTED DESCRIPTIVELY DUE TO THE SMALL SAMPLE SIZE, THE IMPACT OF THESE TRENDS SHOULD BE INTERPRETED CAREFULLY. CONCLUSION: OUR PILOT STUDY SHOWED PROMISING RESULTS IN FEASIBILITY, SAFETY, AND ACCEPTABILITY OF THE TELE-YOGA INTERVENTION. SOME CHANGES IN THE PROTOCOL HAVE BEEN MADE TO DECREASE THE RISK OF MISSING DATA IN THE MEASURES OF PHYSICAL FUNCTION AND IN THE FULL-SCALE RCT NOW ONGOING THE RESULTS OF THE SAMPLE SIZE CALCULATION FOR 300 PARTICIPANTS HAVE INCLUDED THE ESTIMATED LEVEL OF DROP OUTS AND MISSING DATA. 2021 7 1165 79 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 8 2852 58 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH. 2017 9 1632 53 MIYOGA: A RANDOMISED CONTROLLED TRIAL OF A MINDFULNESS MOVEMENT PROGRAMME BASED ON HATHA YOGA PRINCIPLES FOR CHILDREN WITH CEREBRAL PALSY: A STUDY PROTOCOL. INTRODUCTION: CEREBRAL PALSY (CP) IS THE MOST COMMON CHILDHOOD PHYSICAL DISABILITY, WITH LIFE-LONG IMPACTS FOR 1.77 IN 1000 CHILDREN. ALTHOUGH CP IS PRIMARILY A PHYSICAL DISABILITY, CHILDREN WITH CP HAVE AN INCREASED RISK OF EXPERIENCING COGNITIVE DIFFICULTIES, PARTICULARLY ATTENTION AND EXECUTIVE FUNCTION DEFICITS. IMPAIRMENT IN COGNITIVE ABILITIES CAN LEAD TO SUBSEQUENT IMPAIRMENT IN INDEPENDENT FUNCTIONING, EDUCATION, EMPLOYMENT AND INTERPERSONAL RELATIONSHIPS. THIS PAPER REPORTS THE PROTOCOL OF A RANDOMISED CONTROLLED TRIAL OF A NOVEL FAMILY-CENTRED LIFESTYLE INTERVENTION BASED ON MINDFULNESS AND HATHA YOGA PRINCIPLES (MIYOGA). MIYOGA AIMS TO ENHANCE CHILD AND PARENT OUTCOMES FOR CHILDREN WITH CP. METHODS AND ANALYSIS: THE AIM IS TO RECRUIT 36 CHILD-PARENT DYADS (CHILDREN AGED 6-16 YEARS; BILATERAL OR UNILATERAL CP; GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM I-III), WHO WILL BE RANDOMLY ASSIGNED TO TWO GROUPS: MIYOGA ANDWAITLISTT CONTROL. THE MIYOGA PROGRAMME WILL BE FACILITATED IN A GROUP FORMAT FOR 8 WEEKS. ASSESSMENTS WILL BE ADMINISTERED AT BASELINE, PRIOR TO MIYOGA, FOLLOWING COMPLETION OF MIYOGA, AND AT 6-MONTH FOLLOW-UP (RETENTION). THE PRIMARY OUTCOME WILL BE THE CHILD'S SUSTAINED ATTENTIONAL ABILITY AS MEASURED BY THE CONNER'S CONTINUOUS PERFORMANCE TEST II. OTHER OUTCOMES OF INTEREST FOR CHILDREN WITH CP CONSISTS OF ATTENTIONAL CONTROL, PHYSICAL FUNCTIONING, BEHAVIOURAL AND WELL-BEING. FOR PARENTS, THE OUTCOMES OF INTEREST ARE MINDFULNESS, PSYCHOLOGICAL FLEXIBILITY AND WELL-BEING. DATA WILL BE ANALYSED USING GENERAL LINEAR MODELS, SPECIFICALLY ANALYSIS OF COVARIANCE AND ANALYSIS OF VARIANCE. ETHICS AND DISSEMINATION: FULL ETHICAL APPROVAL FOR THIS STUDY HAS BEEN OBTAINED BY THE CHILDREN'S HEALTH QUEENSLAND HOSPITAL AND HEALTH SERVICE RESEARCH ETHICS COMMITTEE (HREC/12/QRCH/120) AND THE UNIVERSITY OF QUEENSLAND (2012000993). IF MIYOGA IS PROVEN EFFECTIVE, ITS DISSEMINATION WOULD ASSIST CHILDREN WITH CP AND COMPLEMENT THEIR ONGOING THERAPY BY IMPROVING THE ABILITY OF THE CHILD TO PAY ATTENTION AT SCHOOL AND IN THERAPY, AND ALLEVIATING ENVIRONMENTALSTRESSORSS FOR BOTH THE CHILD AND HIS/HER PARENTS. TRIAL REGISTRATION NUMBER: ACTRN12613000729729; PRE-RESULTS.HTTP://WWW.ANZCTR.ORG.AU/ACTRN12613000729729.ASPX DATE OF TRIAL REGISTRATION: PROSPECTIVELY REGISTERED ON 2 JULY 2013-PRESENT (ONGOING). FINDINGS TO DATE: RECRUITMENT IS COMPLETE. DATA ARE STILL BEING COLLECTED AT PRESENT. WE AIM TO COMPLETE DATA COLLECTION BY FEBRUARY 2017. 2017 10 518 49 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013 11 2829 77 YOGA VERSUS STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT SPIRITUAL PRACTICE THAT ORIGINATED IN INDIA AND IS CURRENTLY ACCEPTED IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA TO DETERMINE ITS EFFICACY AS AN ADJUNCT TO STANDARD-CARE TREATMENT. OBJECTIVES: TO EXAMINE THE EFFECTS OF YOGA VERSUS STANDARD CARE FOR PEOPLE WITH SCHIZOPHRENIA. SEARCH METHODS: WE SEARCHED THE COCHRANE SCHIZOPHRENIA GROUP TRIALS REGISTER (NOVEMBER 2012 AND JANUARY 29, 2015), WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSIS, AMED, PSYCINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE WERE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA COMPARING YOGA TO STANDARD-CARE CONTROL. DATA COLLECTION AND ANALYSIS: THE REVIEW TEAM INDEPENDENTLY SELECTED STUDIES, QUALITY RATED THESE, AND EXTRACTED DATA. FOR BINARY OUTCOMES, WE CALCULATED RISK RATIO (RR) AND ITS 95% CONFIDENCE INTERVAL (CI), ON AN INTENTION-TO-TREAT BASIS. FOR CONTINUOUS DATA, WE ESTIMATED THE MEAN DIFFERENCE (MD) BETWEEN GROUPS AND ITS 95% CI. WE EMPLOYED MIXED-EFFECT AND FIXED-EFFECT MODELS FOR ANALYSES. WE EXAMINED DATA FOR HETEROGENEITY (I(2) TECHNIQUE), ASSESSED RISK OF BIAS FOR INCLUDED STUDIES, AND CREATED 'SUMMARY OF FINDINGS' TABLES USING GRADE (GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT AND EVALUATION). MAIN RESULTS: WE INCLUDED EIGHT STUDIES IN THE REVIEW. ALL OUTCOMES WERE SHORT TERM (LESS THAN SIX MONTHS). THERE WERE CLEAR DIFFERENCES IN A NUMBER OF OUTCOMES IN FAVOUR OF THE YOGA GROUP, ALTHOUGH THESE WERE BASED ON ONE STUDY EACH, WITH THE EXCEPTION OF LEAVING THE STUDY EARLY. THESE INCLUDED MENTAL STATE (IMPROVEMENT IN POSITIVE AND NEGATIVE SYNDROME SCALE, 1 RCT, N = 83, RR 0.70 CI 0.55 TO 0.88, MEDIUM-QUALITY EVIDENCE), SOCIAL FUNCTIONING (IMPROVEMENT IN SOCIAL OCCUPATIONAL FUNCTIONING SCALE, 1 RCT, N = 83, RR 0.88 CI 0.77 TO 1, MEDIUM-QUALITY EVIDENCE), QUALITY OF LIFE (AVERAGE CHANGE 36-ITEM SHORT FORM SURVEY (SF-36) QUALITY-OF-LIFE SUBSCALE, 1 RCT, N = 60, MD 15.50, 95% CI 4.27 TO 26.73, LOW-QUALITY EVIDENCE), AND LEAVING THE STUDY EARLY (8 RCTS, N = 457, RR 0.91 CI 0.6 TO 1.37, MEDIUM-QUALITY EVIDENCE). FOR THE OUTCOME OF PHYSICAL HEALTH, THERE WAS NOT A CLEAR DIFFERENCE BETWEEN GROUPS (AVERAGE CHANGE SF-36 PHYSICAL-HEALTH SUBSCALE, 1 RCT, N = 60, MD 6.60, 95% CI -2.44 TO 15.64, LOW-QUALITY EVIDENCE). ONLY ONE STUDY REPORTED ADVERSE EFFECTS, FINDING NO INCIDENCE OF ADVERSE EVENTS IN EITHER TREATMENT GROUP. THIS REVIEW WAS SUBJECT TO A CONSIDERABLE NUMBER OF MISSING OUTCOMES, WHICH INCLUDED GLOBAL STATE, CHANGE IN COGNITION, COSTS OF CARE, EFFECT ON STANDARD CARE, SERVICE INTERVENTION, DISABILITY, AND ACTIVITIES OF DAILY LIVING. AUTHORS' CONCLUSIONS: EVEN THOUGH WE FOUND SOME POSITIVE EVIDENCE IN FAVOUR OF YOGA OVER STANDARD-CARE CONTROL, THIS SHOULD BE INTERPRETED CAUTIOUSLY IN VIEW OF OUTCOMES LARGELY BASED EACH ON ONE STUDY WITH LIMITED SAMPLE SIZES AND SHORT-TERM FOLLOW-UP. OVERALL, MANY OUTCOMES WERE NOT REPORTED AND EVIDENCE PRESENTED IN THIS REVIEW IS OF LOW TO MODERATE QUALITY - -TOO WEAK TO INDICATE THAT YOGA IS SUPERIOR TO STANDARD-CARE CONTROL FOR THE MANAGEMENT OF SCHIZOPHRENIA. 2015 12 2657 82 YOGA IN ADDITION TO STANDARD CARE FOR PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES. BACKGROUND: HAEMATOLOGICAL MALIGNANCIES ARE MALIGNANT NEOPLASMS OF THE MYELOID OR LYMPHATIC CELL LINES INCLUDING LEUKAEMIA, LYMPHOMA AND MYELOMA. IN ORDER TO MANAGE PHYSICAL AND PSYCHOLOGICAL ASPECTS OF THE DISEASE AND ITS TREATMENT, COMPLEMENTARY THERAPIES LIKE YOGA ARE COMING INCREASINGLY INTO FOCUS. HOWEVER, THE EFFECTIVENESS OF YOGA PRACTICE FOR PEOPLE SUFFERING FROM HAEMATOLOGICAL MALIGNANCIES REMAINS UNCLEAR. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA PRACTICE IN ADDITION TO STANDARD CANCER TREATMENT FOR PEOPLE WITH HAEMATOLOGICAL MALIGNANCIES. SEARCH METHODS: OUR SEARCH STRATEGY INCLUDED THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL), MEDLINE (1950 TO 4TH FEBRUARY 2014), DATABASES OF ONGOING TRIALS (CONTROLLED-TRIALS.COM; CLINICALTRIALS.GOV), CONFERENCE PROCEEDINGS OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY, THE AMERICAN SOCIETY OF HEMATOLOGY, THE EUROPEAN HAEMATOLOGY ASSOCIATION, THE EUROPEAN CONGRESS FOR INTEGRATIVE MEDICINE, AND GLOBAL ADVANCES IN HEALTH AND MEDICINE. WE HANDSEARCHED REFERENCES OF THESE STUDIES FROM IDENTIFIED TRIALS AND RELEVANT REVIEW ARTICLES. TWO REVIEW AUTHORS INDEPENDENTLY SCREENED THE SEARCH RESULTS. SELECTION CRITERIA: WE INCLUDED RANDOMISED CONTROLLED TRIALS (RCTS) OF YOGA IN ADDITION TO STANDARD CARE FOR HAEMATOLOGICAL MALIGNANCIES COMPARED WITH STANDARD CARE ONLY. WE DID NOT RESTRICT THIS TO ANY SPECIFIC STYLE OF YOGA. DATA COLLECTION AND ANALYSIS: TWO REVIEW AUTHORS INDEPENDENTLY EXTRACTED DATA FOR ELIGIBLE STUDIES AND ASSESSED THE RISK OF BIAS ACCORDING TO PREDEFINED CRITERIA. WE EVALUATED DISTRESS, FATIGUE, ANXIETY, DEPRESSION AND QUALITY OF SLEEP. FURTHER OUTCOMES WE PLANNED TO ASSESS WERE HEALTH-RELATED QUALITY OF LIFE (HRQOL), OVERALL SURVIVAL (OS) AND ADVERSE EVENTS (AE), BUT DATA ON THESE WERE NOT AVAILABLE. MAIN RESULTS: OUR SEARCH STRATEGIES LED TO 149 POTENTIALLY RELEVANT REFERENCES, BUT ONLY A SINGLE SMALL STUDY MET OUR INCLUSION CRITERIA. THE INCLUDED STUDY WAS PUBLISHED AS A FULL TEXT ARTICLE AND INVESTIGATED THE FEASIBILITY AND EFFECT OF TIBETAN YOGA ADDITIONAL TO STANDARD CARE (N = 20; 1 PERSON DROPPED OUT BEFORE ATTENDING ANY CLASSES AND NO DATA WERE COLLECTED) COMPARED TO STANDARD CARE ONLY (N = 19). THE STUDY INCLUDED PEOPLE WITH ALL STAGES OF HODGKIN AND NON-HODGKIN'S LYMPHOMA, WITH AND WITHOUT CURRENT CANCER TREATMENT. THE MEAN AGE WAS 51 YEARS.WE JUDGED THE OVERALL RISK OF BIAS AS HIGH AS WE FOUND A HIGH RISK FOR PERFORMANCE, DETECTION AND ATTRITION BIAS. ADDITIONALLY, POTENTIAL OUTCOME REPORTING BIAS COULD NOT BE COMPLETELY RULED OUT. FOLLOWING THE RECOMMENDATIONS OF GRADE, WE JUDGED THE OVERALL QUALITY OF THE BODY OF EVIDENCE FOR ALL PREDEFINED OUTCOMES AS 'VERY LOW', DUE TO THE METHODICAL LIMITATIONS AND THE VERY SMALL SAMPLE SIZE.THE INFLUENCE OF YOGA ON HRQOL AND OS WAS NOT REPORTED. THERE IS NO EVIDENCE THAT YOGA IN ADDITION TO STANDARD CARE COMPARED WITH STANDARD CARE ONLY CAN IMPROVE DISTRESS IN PEOPLE WITH HAEMATOLOGICAL MALIGNANCIES (MEAN DIFFERENCE (MD) -0.30, 95% CONFIDENCE INTERVAL (CI) -5.55 TO 4.95; P = 0.91). SIMILARLY, THERE IS NO EVIDENCE OF A DIFFERENCE BETWEEN EITHER GROUP FOR FATIGUE (MD 0.00, 95% CI -0.94 TO 0.94; P = 1.00), ANXIETY (MD 0.30, 95% CI -5.01 TO 5.61; P = 0.91) OR DEPRESSION (MD -0.70, 95% CI -3.21 TO 1.81; P = 0.58).THERE IS VERY LOW QUALITY EVIDENCE THAT YOGA IMPROVES THE OVERALL QUALITY OF SLEEP (MD -2.30, 95% CI -3.78 TO -0.82; P = 0.002). THE YOGA GROUPS' TOTAL SCORE FOR THE PITTSBURGH SLEEP QUALITY INDEX (PSQI) WAS 5.8 (+/- 2.3 SD) AND BETTER THAN THE TOTAL SCORE (8.1 (+/- 2.4 SD)) OF THE CONTROL GROUP. A PSQI TOTAL SCORE OF 0 TO 5 INDICATES GOOD SLEEP WHEREAS PSQI TOTAL SCORE 6 TO 21 POINTS TOWARDS SIGNIFICANT SLEEP DISTURBANCES. THE OCCURRENCE OF AES WAS NOT REPORTED. AUTHORS' CONCLUSIONS: THE CURRENTLY AVAILABLE DATA PROVIDE LITTLE INFORMATION ABOUT THE EFFECTIVENESS OF YOGA INTERVENTIONS FOR PEOPLE SUFFERING FROM HAEMATOLOGICAL MALIGNANCIES. THE FINDING THAT YOGA MAY BE BENEFICIAL FOR THE PATIENTS' QUALITY OF SLEEP IS BASED ON A VERY SMALL BODY OF EVIDENCE. THEREFORE, THE ROLE OF YOGA AS AN ADDITIONAL THERAPY FOR HAEMATOLOGICAL MALIGNANCIES REMAINS UNCLEAR. FURTHER HIGH-QUALITY RANDOMISED CONTROLLED TRIALS WITH LARGER NUMBERS OF PARTICIPANTS ARE NEEDED TO MAKE A DEFINITIVE STATEMENT. 2014 13 162 69 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 14 2861 57 YOGA-BASED EXERCISE TO PREVENT FALLS IN COMMUNITY-DWELLING PEOPLE AGED 60 YEARS AND OVER: STUDY PROTOCOL FOR THE SUCCESSFUL AGEING (SAGE) YOGA RANDOMISED CONTROLLED TRIAL. INTRODUCTION: FALLS SIGNIFICANTLY REDUCE INDEPENDENCE AND QUALITY OF LIFE IN OLDER AGE. BALANCE-SPECIFIC EXERCISE PREVENTS FALLS IN PEOPLE AGED 60+ YEARS. YOGA IS GROWING IN POPULARITY AND CAN PROVIDE A HIGH CHALLENGE TO BALANCE; HOWEVER, THE EFFECT OF YOGA ON FALLS HAS NOT BEEN EVALUATED. THIS TRIAL AIMS TO ESTABLISH THE EFFECT ON FALLS OF A YOGA EXERCISE PROGRAMME COMPARED WITH A YOGA RELAXATION PROGRAMME IN COMMUNITY-DWELLERS AGED 60+ YEARS. METHOD AND ANALYSIS: THIS RANDOMISED CONTROLLED TRIAL WILL INVOLVE 560 COMMUNITY-DWELLING PEOPLE AGED 60+ YEARS. PARTICIPANTS WILL BE RANDOMISED TO EITHER: (1) THE SUCCESSFUL AGEING (SAGE) YOGA EXERCISE PROGRAMME OR (2) A YOGA RELAXATION PROGRAMME. PRIMARY OUTCOME IS RATE OF FALLS IN THE 12 MONTHS POST RANDOMISATION. SECONDARY OUTCOMES INCLUDE MENTAL WELL-BEING, PHYSICAL ACTIVITY, HEALTH-RELATED QUALITY OF LIFE, BALANCE SELF-CONFIDENCE, PHYSICAL FUNCTION, PAIN, GOAL ATTAINMENT AND SLEEP QUALITY AT 12 MONTHS AFTER RANDOMISATION. THE NUMBER OF FALLS PER PERSON-YEAR WILL BE ANALYSED USING NEGATIVE BINOMIAL REGRESSION MODELS TO ESTIMATE BETWEEN-GROUP DIFFERENCE IN FALL RATES. GENERALISED LINEAR MODELS WILL ASSESS THE EFFECT OF GROUP ALLOCATION ON THE CONTINUOUSLY SCORED SECONDARY OUTCOMES, ADJUSTING FOR BASELINE SCORES. AN ECONOMIC ANALYSIS WILL COMPARE THE COST-EFFECTIVENESS AND COST-UTILITY OF THE TWO YOGA PROGRAMMES. ETHICS AND DISSEMINATION: PROTOCOL WAS APPROVED BY THE HUMAN RESEARCH ETHICS COMMITTEE AT THE UNIVERSITY OF SYDNEY, AUSTRALIA (APPROVAL 2019/604). TRIAL RESULTS WILL BE DISSEMINATED VIA PEER-REVIEWED ARTICLES, CONFERENCE PRESENTATIONS, LAY SUMMARIES. TRIAL REGISTRATION NUMBER: THE PROTOCOL FOR THIS TRIAL IS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY (ACTRN12619001183178). 2020 15 2857 60 YOGA-BASED CARDIAC REHABILITATION AFTER ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL. BACKGROUND: GIVEN THE SHORTAGE OF CARDIAC REHABILITATION (CR) PROGRAMS IN INDIA AND POOR UPTAKE WORLDWIDE, THERE IS AN URGENT NEED TO FIND ALTERNATIVE MODELS OF CR THAT ARE INEXPENSIVE AND MAY OFFER CHOICE TO SUBGROUPS WITH POOR UPTAKE (E.G., WOMEN AND ELDERLY). OBJECTIVES: THIS STUDY SOUGHT TO EVALUATE THE EFFECTS OF YOGA-BASED CR (YOGA-CARE) ON MAJOR CARDIOVASCULAR EVENTS AND SELF-RATED HEALTH IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL. METHODS: THE TRIAL WAS CONDUCTED IN 24 MEDICAL CENTERS ACROSS INDIA. THIS STUDY RECRUITED 3,959 PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITH A MEDIAN AND MINIMUM FOLLOW-UP OF 22 AND 6 MONTHS. PATIENTS WERE INDIVIDUALLY RANDOMIZED TO RECEIVE EITHER A YOGA-CARE PROGRAM (N = 1,970) OR ENHANCED STANDARD CARE INVOLVING EDUCATIONAL ADVICE (N = 1,989). THE CO-PRIMARY OUTCOMES WERE: 1) FIRST OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) (COMPOSITE OF ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, STROKE, OR EMERGENCY CARDIOVASCULAR HOSPITALIZATION); AND 2) SELF-RATED HEALTH ON THE EUROPEAN QUALITY OF LIFE-5 DIMENSIONS-5 LEVEL VISUAL ANALOGUE SCALE AT 12 WEEKS. RESULTS: MACE OCCURRED IN 131 (6.7%) PATIENTS IN THE YOGA-CARE GROUP AND 146 (7.4%) PATIENTS IN THE ENHANCED STANDARD CARE GROUP (HAZARD RATIO WITH YOGA-CARE: 0.90; 95% CONFIDENCE INTERVAL [CI]: 0.71 TO 1.15; P = 0.41). SELF-RATED HEALTH WAS 77 IN YOGA-CARE AND 75.7 IN THE ENHANCED STANDARD CARE GROUP (BASELINE-ADJUSTED MEAN DIFFERENCE IN FAVOR OF YOGA-CARE: 1.5; 95% CI: 0.5 TO 2.5; P = 0.002). THE YOGA-CARE GROUP HAD GREATER RETURN TO PRE-INFARCT ACTIVITIES, BUT THERE WAS NO DIFFERENCE IN TOBACCO CESSATION OR MEDICATION ADHERENCE BETWEEN THE TREATMENT GROUPS (SECONDARY OUTCOMES). CONCLUSIONS: YOGA-CARE IMPROVED SELF-RATED HEALTH AND RETURN TO PRE-INFARCT ACTIVITIES AFTER ACUTE MYOCARDIAL INFARCTION, BUT THE TRIAL LACKED STATISTICAL POWER TO SHOW A DIFFERENCE IN MACE. YOGA-CARE MAY BE AN OPTION WHEN CONVENTIONAL CR IS UNAVAILABLE OR UNACCEPTABLE TO INDIVIDUALS. (A STUDY ON EFFECTIVENESS OF YOGA BASED CARDIAC REHABILITATION PROGRAMME IN INDIA AND UNITED KINGDOM; CTRI/2012/02/002408). 2020 16 199 51 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349. 2019 17 2638 54 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 18 2543 87 YOGA FOR ASTHMA. BACKGROUND: ASTHMA IS A COMMON CHRONIC INFLAMMATORY DISORDER AFFECTING ABOUT 300 MILLION PEOPLE WORLDWIDE. AS A HOLISTIC THERAPY, YOGA HAS THE POTENTIAL TO RELIEVE BOTH THE PHYSICAL AND PSYCHOLOGICAL SUFFERING OF PEOPLE WITH ASTHMA, AND ITS POPULARITY HAS EXPANDED GLOBALLY. A NUMBER OF CLINICAL TRIALS HAVE BEEN CARRIED OUT TO EVALUATE THE EFFECTS OF YOGA PRACTICE, WITH INCONSISTENT RESULTS. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA IN PEOPLE WITH ASTHMA. SEARCH METHODS: WE SYSTEMATICALLY SEARCHED THE COCHRANE AIRWAYS GROUP REGISTER OF TRIALS, WHICH IS DERIVED FROM SYSTEMATIC SEARCHES OF BIBLIOGRAPHIC DATABASES INCLUDING THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL), MEDLINE, EMBASE, CINAHL, AMED, AND PSYCINFO, AND HANDSEARCHING OF RESPIRATORY JOURNALS AND MEETING ABSTRACTS. WE ALSO SEARCHED PEDRO. WE SEARCHED CLINICALTRIALS.GOV AND THE WHO ICTRP SEARCH PORTAL. WE SEARCHED ALL DATABASES FROM THEIR INCEPTION TO 22 JULY 2015, AND USED NO RESTRICTION ON LANGUAGE OF PUBLICATION. WE CHECKED THE REFERENCE LISTS OF ELIGIBLE STUDIES AND RELEVANT REVIEW ARTICLES FOR ADDITIONAL STUDIES. WE ATTEMPTED TO CONTACT INVESTIGATORS OF ELIGIBLE STUDIES AND EXPERTS IN THE FIELD TO LEARN OF OTHER PUBLISHED AND UNPUBLISHED STUDIES. SELECTION CRITERIA: WE INCLUDED RANDOMISED CONTROLLED TRIALS (RCTS) THAT COMPARED YOGA WITH USUAL CARE (OR NO INTERVENTION) OR SHAM INTERVENTION IN PEOPLE WITH ASTHMA AND REPORTED AT LEAST ONE OF THE FOLLOWING OUTCOMES: QUALITY OF LIFE, ASTHMA SYMPTOM SCORE, ASTHMA CONTROL, LUNG FUNCTION MEASURES, ASTHMA MEDICATION USAGE, AND ADVERSE EVENTS. DATA COLLECTION AND ANALYSIS: WE EXTRACTED BIBLIOGRAPHIC INFORMATION, CHARACTERISTICS OF PARTICIPANTS, CHARACTERISTICS OF INTERVENTIONS AND CONTROLS, CHARACTERISTICS OF METHODOLOGY, AND RESULTS FOR THE OUTCOMES OF OUR INTEREST FROM ELIGIBLE STUDIES. FOR CONTINUOUS OUTCOMES, WE USED MEAN DIFFERENCE (MD) WITH 95% CONFIDENCE INTERVAL (CI) TO DENOTE THE TREATMENT EFFECTS, IF THE OUTCOMES WERE MEASURED BY THE SAME SCALE ACROSS STUDIES. ALTERNATIVELY, IF THE OUTCOMES WERE MEASURED BY DIFFERENT SCALES ACROSS STUDIES, WE USED STANDARDISED MEAN DIFFERENCE (SMD) WITH 95% CI. FOR DICHOTOMOUS OUTCOMES, WE USED RISK RATIO (RR) WITH 95% CI TO MEASURE THE TREATMENT EFFECTS. WE PERFORMED META-ANALYSIS WITH REVIEW MANAGER 5.3. WE USED THE FIXED-EFFECT MODEL TO POOL THE DATA, UNLESS THERE WAS SUBSTANTIAL HETEROGENEITY AMONG STUDIES, IN WHICH CASE WE USED THE RANDOM-EFFECTS MODEL INSTEAD. FOR OUTCOMES INAPPROPRIATE OR IMPOSSIBLE TO POOL QUANTITATIVELY, WE CONDUCTED A DESCRIPTIVE ANALYSIS AND SUMMARISED THE FINDINGS NARRATIVELY. MAIN RESULTS: WE INCLUDED 15 RCTS WITH A TOTAL OF 1048 PARTICIPANTS. MOST OF THE TRIALS WERE CONDUCTED IN INDIA, FOLLOWED BY EUROPE AND THE UNITED STATES. THE MAJORITY OF PARTICIPANTS WERE ADULTS OF BOTH SEXES WITH MILD TO MODERATE ASTHMA FOR SIX MONTHS TO MORE THAN 23 YEARS. FIVE STUDIES INCLUDED YOGA BREATHING ALONE, WHILE THE OTHER STUDIES ASSESSED YOGA INTERVENTIONS THAT INCLUDED BREATHING, POSTURE, AND MEDITATION. INTERVENTIONS LASTED FROM TWO WEEKS TO 54 MONTHS, FOR NO MORE THAN SIX MONTHS IN THE MAJORITY OF STUDIES. THE RISK OF BIAS WAS LOW ACROSS ALL DOMAINS IN ONE STUDY AND UNCLEAR OR HIGH IN AT LEAST ONE DOMAIN FOR THE REMAINDER.THERE WAS SOME EVIDENCE THAT YOGA MAY IMPROVE QUALITY OF LIFE (MD IN ASTHMA QUALITY OF LIFE QUESTIONNAIRE (AQLQ) SCORE PER ITEM 0.57 UNITS ON A 7-POINT SCALE, 95% CI 0.37 TO 0.77; 5 STUDIES; 375 PARTICIPANTS), IMPROVE SYMPTOMS (SMD 0.37, 95% CI 0.09 TO 0.65; 3 STUDIES; 243 PARTICIPANTS), AND REDUCE MEDICATION USAGE (RR 5.35, 95% CI 1.29 TO 22.11; 2 STUDIES) IN PEOPLE WITH ASTHMA. THE MD FOR AQLQ SCORE EXCEEDED THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE (MCID) OF 0.5, BUT WHETHER THE MEAN CHANGES EXCEEDED THE MCID FOR ASTHMA SYMPTOMS IS UNCERTAIN DUE TO THE LACK OF AN ESTABLISHED MCID IN THE SEVERITY SCORES USED IN THE INCLUDED STUDIES. THE EFFECTS OF YOGA ON CHANGE FROM BASELINE FORCED EXPIRATORY VOLUME IN ONE SECOND (MD 0.04 LITRES, 95% CI -0.10 TO 0.19; 7 STUDIES; 340 PARTICIPANTS; I(2) = 68%) WERE NOT STATISTICALLY SIGNIFICANT. TWO STUDIES INDICATED IMPROVED ASTHMA CONTROL, BUT DUE TO VERY SIGNIFICANT HETEROGENEITY (I(2) = 98%) WE DID NOT POOL DATA. NO SERIOUS ADVERSE EVENTS ASSOCIATED WITH YOGA WERE REPORTED, BUT THE DATA ON THIS OUTCOME WAS LIMITED. AUTHORS' CONCLUSIONS: WE FOUND MODERATE-QUALITY EVIDENCE THAT YOGA PROBABLY LEADS TO SMALL IMPROVEMENTS IN QUALITY OF LIFE AND SYMPTOMS IN PEOPLE WITH ASTHMA. THERE IS MORE UNCERTAINTY ABOUT POTENTIAL ADVERSE EFFECTS OF YOGA AND ITS IMPACT ON LUNG FUNCTION AND MEDICATION USAGE. RCTS WITH A LARGE SAMPLE SIZE AND HIGH METHODOLOGICAL AND REPORTING QUALITY ARE NEEDED TO CONFIRM THE EFFECTS OF YOGA FOR ASTHMA. 2016 19 2827 79 YOGA VERSUS NON-STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT SPIRITUAL PRACTICE THAT ORIGINATED IN INDIA AND IS CURRENTLY ACCEPTED IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA AS AN ALTERNATIVE OR ADJUNCTIVE TREATMENT. OBJECTIVES: TO SYSTEMATICALLY ASSESS THE EFFECTS OF YOGA VERSUS NON-STANDARD CARE FOR PEOPLE WITH SCHIZOPHRENIA. SEARCH METHODS: THE INFORMATION SPECIALIST OF THE COCHRANE SCHIZOPHRENIA GROUP SEARCHED THEIR SPECIALISED TRIALS REGISTER (LATEST 30 MARCH 2017), WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSIS, AMED, PSYCINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE ARE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA AND COMPARING YOGA WITH NON-STANDARD CARE. WE INCLUDED TRIALS THAT MET OUR SELECTION CRITERIA AND REPORTED USEABLE DATA. DATA COLLECTION AND ANALYSIS: THE REVIEW TEAM INDEPENDENTLY SELECTED STUDIES, ASSESSED QUALITY, AND EXTRACTED DATA. FOR BINARY OUTCOMES, WE CALCULATED RISK RATIO (RR) AND ITS 95% CONFIDENCE INTERVAL (CI), ON AN INTENTION-TO-TREAT BASIS. FOR CONTINUOUS DATA, WE ESTIMATED THE MEAN DIFFERENCE (MD) BETWEEN GROUPS AND ITS 95% CI. WE EMPLOYED A FIXED-EFFECT MODELS FOR ANALYSES. WE EXAMINED DATA FOR HETEROGENEITY (I(2) TECHNIQUE), ASSESSED RISK OF BIAS FOR INCLUDED STUDIES, AND CREATED A 'SUMMARY OF FINDINGS' TABLE FOR SEVEN MAIN OUTCOMES OF INTEREST USING GRADE (GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT AND EVALUATION). MAIN RESULTS: WE WERE ABLE TO INCLUDE SIX STUDIES (586 PARTICIPANTS). NON-STANDARD CARE CONSISTED SOLELY OF ANOTHER TYPE OF EXERCISE PROGRAMME. ALL OUTCOMES WERE SHORT TERM (LESS THAN SIX MONTHS). THERE WAS A CLEAR DIFFERENCE IN THE OUTCOME LEAVING THE STUDY EARLY (6 RCTS, N=586, RR 0.64 CI 0.49 TO 0.83, MEDIUM QUALITY EVIDENCE) IN FAVOUR OF THE YOGA GROUP. THERE WERE NO CLEAR DIFFERENCES BETWEEN GROUPS FOR THE REMAINING OUTCOMES. THESE INCLUDED MENTAL STATE (IMPROVEMENT IN POSITIVE AND NEGATIVE SYNDROME SCALE, 1 RCT, N=84, RR 0.81 CI 0.62 TO 1.07, LOW QUALITY EVIDENCE), SOCIAL FUNCTIONING (IMPROVEMENT IN SOCIAL OCCUPATIONAL FUNCTIONING SCALE, 1 RCT, N=84, RR 0.90 CI 0.78 TO 1.04, LOW QUALITY EVIDENCE), QUALITY OF LIFE (MENTAL HEALTH) (AVERAGE CHANGE 36-ITEM SHORT FORM SURVEY (SF-36) QUALITY-OF-LIFE SUB-SCALE, 1 RCT, N=69, MD -5.30 CI -17.78 TO 7.18, LOW QUALITY EVIDENCE), PHYSICAL HEALTH, (AVERAGE CHANGE WHOQOL-BREF PHYSICAL-HEALTH SUB-SCALE, 1 RCT, N=69, MD 9.22 CI -0.42 TO 18.86, LOW QUALITY EVIDENCE). ONLY ONE STUDY REPORTED ADVERSE EFFECTS, FINDING NO INCIDENCE OF ADVERSE EVENTS IN EITHER TREATMENT GROUP. THERE WERE A CONSIDERABLE NUMBER OF MISSING OUTCOMES, WHICH INCLUDED RELAPSE, CHANGE IN COGNITION, COSTS OF CARE, EFFECT ON STANDARD CARE, SERVICE INTERVENTION, DISABILITY, AND ACTIVITIES OF DAILY LIVING. AUTHORS' CONCLUSIONS: WE FOUND MINIMAL DIFFERENCES BETWEEN YOGA AND NON-STANDARD CARE, THE LATTER CONSISTING OF ANOTHER EXERCISE COMPARATOR, WHICH COULD BE BROADLY CONSIDERED AEROBIC EXERCISE. OUTCOMES WERE LARGELY BASED ON SINGLE STUDIES WITH LIMITED SAMPLE SIZES AND SHORT-TERM FOLLOW-UP. OVERALL, MANY OUTCOMES WERE NOT REPORTED AND EVIDENCE PRESENTED IN THIS REVIEW IS OF LOW TO MODERATE QUALITY - TOO WEAK TO INDICATE THAT YOGA IS SUPERIOR OR INFERIOR TO NON-STANDARD CARE CONTROL FOR MANAGEMENT OF PEOPLE WITH SCHIZOPHRENIA. 2017 20 2121 50 THE EFFECTIVENESS AND CHARACTERISTICS OF PREGNANCY YOGA INTERVENTIONS: A SYSTEMATIC REVIEW PROTOCOL. BACKGROUND: THE PURPOSE OF THIS REVIEW IS TO SYSTEMATICALLY EXAMINE THE REPORTED CLINICAL EFFECTIVENESS OF PREGNANCY YOGA. THE REVIEW WILL USE THE FITT (FREQUENCY, INTENSITY, TIME/DURATION AND TYPE) PRINCIPLE OF PHYSICAL ACTIVITY TO CHARACTERISE THE DIFFERENT TYPES OF YOGA INTERVENTIONS THAT HAVE BEEN EVALUATED IN THE INCLUDED STUDIES. STUDIES WILL BE CATEGORISED AS EFFECTIVENESS OR EFFICACY STUDIES AND THIS CONTINUUM OF EFFICACY VERSUS EFFECTIVENESS WILL BE INCORPORATED INTO THE FULL REVIEW. METHODS/DESIGN: THE FOLLOWING ELECTRONIC DATABASES WILL BE SEARCHED USING A DETAILED SEARCH STRATEGY: MEDLINE, PSYCINFO, EMBASE, CINAHL, WHOLIS, AMED, SCIELO, ASSIA AND WEB OF SCIENCE. RANDOMISED CONTROL TRIALS AND QUASI-EXPERIMENTAL STUDIES EXAMINING PREGNANCY YOGA AND REPORTING ON EFFECT WILL BE INCLUDED. TITLES, ABSTRACTS AND FULL ARTICLES WILL BE SCREENED BY TWO INVESTIGATORS INDEPENDENTLY TO IDENTIFY ELIGIBLE STUDIES. THE COCHRANE COLLABORATION'S RISK OF BIAS ASSESSMENT TOOL WILL BE USED TO ASSESS STUDY QUALITY. QUALITY OF THE EVIDENCE WILL BE EVALUATED USING THE GRADE CRITERIA. A STANDARDISED DATA EXTRACTION FORM WILL BE USED TO EXTRACT DATA. EFFECT SIZES WILL BE ESTIMATED USING MEAN DIFFERENCES FOR CONTINUOUS OUTCOMES, AND RELATIVE RISKS FOR DICHOTOMOUS OUTCOME. WHERE POSSIBLE, POOLING OF EFFECT ESTIMATES WILL BE DONE USING A RANDOM EFFECT MODEL. THE OUTCOMES OF INTEREST ARE QUALITY OF LIFE, STRESS, ANXIETY, DEPRESSION, MODE OF BIRTH, LABOUR DURATION AND PAIN MANAGEMENT IN LABOUR. DISCUSSION: THIS REVIEW WILL SYNTHESISE THE BEST AVAILABLE EVIDENCE ON THE EFFECTIVENESS OF YOGA DURING PREGNANCY AND PROVIDE VALUABLE HIGH-QUALITY INFORMATION FOR CLINICIANS AND HEALTH POLICYMAKERS. FINDINGS WILL BE DISSEMINATED THROUGH PUBLICATION IN A PEER-REVIEWED JOURNAL AND PRESENTATION AT RELEVANT CONFERENCE PROCEEDINGS. THE REVIEW WILL MAKE RECOMMENDATIONS FOR THE APPROPRIATE VOLUME, INTENSITY AND TYPE OF PREGNANCY YOGA FOR MAXIMUM EFFECT AND MAY HAVE IMPLICATIONS FOR POLICY AND PRACTICE RELATING TO PREGNANCY YOGA AS AN INTERVENTION. REGISTRATION: PROSPERO, CRD42019119916. REGISTERED ON 11TH JANUARY 2019. 2019