1 888 245 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 2 1204 54 EXPERIENCE OF ELDERLY PEOPLE REGARDING THE EFFECT OF YOGA/LIGHT EXERCISE ON SEDENTARY BEHAVIOR: A LONGITUDINAL QUALITATIVE STUDY IN MADHYA PRADESH, INDIA. THIS STUDY IS SET ON THE BACKGROUND OF A RANDOMIZED CONTROL TRIAL (RCT) IN WHICH INTERVENTION WAS CARRIED TO OBSERVE THE EFFECTS OF YOGA/LIGHT EXERCISE ON THE IMPROVEMENT IN HEALTH AND WELL-BEING AMONG THE ELDERLY POPULATION. A LONGITUDINAL QUALITATIVE STUDY WAS CONDUCTED AS PART OF RCT INTERVENTIONS TO EXPLORE THE EXPERIENCE OF THE ELDERLY PRACTICING YOGA/LIGHT EXERCISE IN RELATION TO SEDENTARY BEHAVIOR IN THE UJJAIN DISTRICT OF MADHYA PRADESH, INDIA. PARTICIPANTS OF THE RCT WERE SELECTED FOR THIS STUDY. EIGHTEEN FOCUS GROUP DISCUSSIONS WERE CONDUCTED-SIX DURING EACH PHASE OF RCT INTERVENTIONS (BEFORE, DURING, AND AFTER). THE FINDINGS REGARDING MOTIVATING AND DEMOTIVATING FACTORS IN VARIOUS PHASES OF INTERVENTION WERE PRESENTED IN THREE CATEGORIES: EXPERIENCE AND PERCEPTION OF THE EFFECTS OF YOGA/LIGHT EXERCISE ON SEDENTARY BEHAVIOR (1) BEFORE, (2) DURING, AND (3) AFTER INTERVENTION. THIS STUDY EXPLORES THE POSITIVE EFFECT OF YOGA/LIGHT EXERCISE ON SEDENTARY BEHAVIOR AND SUBJECTIVE WELL-BEING ON THE ELDERLY POPULATION. THEY WERE RECOGNIZED TO HAVE UNDERGONE CHANGES IN THEIR PHYSICAL AND EMOTIONAL WELL-BEING BY CONSISTENTLY PRACTICING YOGA/LIGHT EXERCISE. THE MAIN DRIVING FACTORS WERE PERIODIC HEALTH CHECK-UPS AND THE ENCOURAGEMENT OF QUALIFIED TRAINERS WITHOUT ANY COST. THIS STUDY CONCLUDES WITH THE NOTION THAT THESE INTERVENTIONS SHOULD BE ENCOURAGED IN THE COMMUNITY TO USE PHYSICAL EXERCISE AS A METHOD TO BETTER CONTROL THE PHYSICAL AND SOCIAL EFFECTS OF AGING. 2020 3 1093 102 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 4 2843 51 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 5 2861 67 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 6 2121 53 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 7 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 8 536 58 COMPARISON OF YOGA VERSUS STRETCHING FOR CHRONIC LOW BACK PAIN: PROTOCOL FOR THE YOGA EXERCISE SELF-CARE (YES) TRIAL. BACKGROUND: BACK PAIN, ONE OF THE MOST PREVALENT CONDITIONS AFFLICTING AMERICAN ADULTS, IS THE LEADING REASON FOR USING COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES. YOGA IS AN INCREASINGLY POPULAR "MIND-BODY" CAM THERAPY OFTEN USED FOR RELIEVING BACK PAIN AND SEVERAL SMALL STUDIES HAVE FOUND YOGA EFFECTIVE FOR THIS CONDITION. THIS STUDY WILL ASSESS WHETHER YOGA IS EFFECTIVE FOR TREATING CHRONIC LOW BACK PAIN COMPARED WITH SELF CARE AND EXERCISE AND WILL EXPLORE THE MECHANISMS RESPONSIBLE FOR ANY OBSERVED BENEFITS. METHODS/DESIGN: A TOTAL OF 210 PARTICIPANTS WITH LOW BACK PAIN LASTING AT LEAST 3 MONTHS WILL BE RECRUITED FROM PRIMARY CARE CLINICS OF A LARGE HEALTHCARE SYSTEM BASED IN SEATTLE. THEY WILL BE RANDOMIZED IN A 2:2:1 RATIO TO RECEIVE 12 WEEKLY YOGA CLASSES, 12 WEEKLY CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OF COMPARABLE PHYSICAL EXERTION, OR A SELF-CARE BOOK. INTERVIEWERS MASKED TO PARTICIPANTS' TREATMENT GROUP WILL ASSESS OUTCOMES AT BASELINE AND 6, 12 AND 26 WEEKS AFTER RANDOMIZATION. PRIMARY OUTCOMES WILL BE BACK-RELATED DYSFUNCTION AND SYMPTOM BOTHERSOMENESS. IN ADDITION, DATA WILL BE COLLECTED ON PHYSICAL MEASUREMENTS (E.G., FLEXION) AT BASELINE AND 12 WEEKS AND SALIVA SAMPLES WILL BE OBTAINED AT BASELINE, 6 AND 12 WEEKS. INFORMATION WILL BE COLLECTED ON SPECIFIC PHYSICAL, PSYCHOLOGICAL, AND PHYSIOLOGICAL FACTORS TO ALLOW EXPLORATION OF POSSIBLE MECHANISMS OF ACTION THROUGH WHICH YOGA COULD RELIEVE BACK PAIN AND DYSFUNCTION. THE EFFECTIVENESS OF YOGA WILL BE ASSESSED USING ANALYSIS OF COVARIANCE (USING GENERAL ESTIMATING EQUATIONS - GEE) WITHIN AN INTENTION-TO-TREAT CONTEXT. IF YOGA IS FOUND EFFECTIVE, FURTHER ANALYSES WILL EXPLORE WHETHER YOGA'S BENEFITS ARE ATTRIBUTABLE TO PHYSICAL, PSYCHOLOGICAL AND/OR PHYSIOLOGICAL FACTORS. CONCLUSIONS: THIS STUDY WILL PROVIDE THE CLEAREST EVIDENCE TO DATE ABOUT THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR TREATING CHRONIC BACK PAIN, AND IF THE RESULTS ARE POSITIVE, WILL HELP FOCUS FUTURE, MORE IN-DEPTH, RESEARCH ON THE MOST PROMISING POTENTIAL MECHANISMS OF ACTION IDENTIFIED BY THIS STUDY. 2010 9 491 34 CO-DESIGNING A NEW YOGA-BASED MINDFULNESS INTERVENTION FOR SURVIVORS OF STROKE: A FORMATIVE EVALUATION. MOVEMENT-BASED MINDFULNESS INTERVENTIONS (MBI) ARE COMPLEX, MULTI-COMPONENT INTERVENTIONS FOR WHICH THE DESIGN PROCESS IS RARELY REPORTED. FOR PEOPLE WITH STROKE, EMERGING EVIDENCE SUGGESTS BENEFITS, BUT MAINSTREAM PROGRAMS ARE GENERALLY UNSUITABLE. WE AIMED TO DESCRIBE THE PROCESSES INVOLVED AND TO CONDUCT A FORMATIVE EVALUATION OF THE DEVELOPMENT OF A NOVEL YOGA-BASED MBI DESIGNED FOR SURVIVORS OF STROKE. WE USED THE MEDICAL RESEARCH COUNCIL COMPLEX INTERVENTIONS FRAMEWORK AND PRINCIPLES OF CO-DESIGN. WE PURPOSEFULLY APPROACHED HEALTH PROFESSIONALS AND CONSUMERS TO ESTABLISH AN ADVISORY COMMITTEE FOR DEVELOPING THE INTERVENTION. MEMBERS COLLABORATED AND ITERATIVELY REVIEWED THE DESIGN AND CONTENT OF THE PROGRAM, FORMATTED INTO A TRAINING MANUAL. FOUR EXTERNAL YOGA TEACHERS INDEPENDENTLY REVIEWED THE PROGRAM. FORMATIVE EVALUATION INCLUDED REVIEW OF MULTIPLE DATA SOURCES AND DOCUMENTATION (E.G., FORMAL MEETING MINUTES, FOCUS GROUP DISCUSSIONS, RESEARCHER OBSERVATIONS). THE DATA WERE SYNTHESIZED USING INDUCTIVE THEMATIC ANALYSIS. THREE BROAD THEMES EMERGED: (A) MBI CONTENT AND TERMINOLOGY; (B) MANUAL DESIGN AND READABILITY; AND (C) BARRIERS AND ENABLERS TO DELIVER THE INTERVENTION. VARIOUS PERSPECTIVES AND FEEDBACK ON ESSENTIAL COMPONENTS GUIDED FINALIZING THE PROGRAM. THE DESIGN PHASE OF A NOVEL YOGA-BASED MBI WAS STRENGTHENED BY INTERDISCIPLINARY, CONSUMER CONTRIBUTIONS AND PEER REVIEW. THE 12-WEEK INTERVENTION IS READY FOR TESTING AMONG SURVIVORS OF STROKE. 2021 10 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 11 156 45 A QUALITATIVE STUDY OF LOVEYOURBRAIN YOGA: A GROUP-BASED YOGA WITH PSYCHOEDUCATION INTERVENTION TO FACILITATE COMMUNITY INTEGRATION FOR PEOPLE WITH TRAUMATIC BRAIN INJURY AND THEIR CAREGIVERS. PURPOSE: TO EXPLORE PARTICIPANTS' EXPERIENCES IN A GROUP-BASED YOGA WITH PSYCHOEDUCATION INTERVENTION DESIGNED TO FACILITATE COMMUNITY INTEGRATION FOR PEOPLE WITH TRAUMATIC BRAIN INJURY AND THEIR CAREGIVERS.MATERIALS AND METHODS: WE CONDUCTED SEMI-STRUCTURED INTERVIEWS WITH 13 PEOPLE WITH TRAUMATIC BRAIN INJURY AND THREE CAREGIVERS WHO HAD COMPLETED LOVEYOURBRAIN YOGA, A 6-SESSION, MANUALIZED, GROUP-BASED YOGA INTERVENTION THAT INCORPORATES BREATHING EXERCISES, YOGA, MEDITATION, AND PSYCHOEDUCATION. INTERVIEWS WERE ANALYZED USING CONTENT ANALYSIS.RESULTS: WE IDENTIFIED SEVEN THEMES: EASE OF PARTICIPATION, BELONGING, SUSTAINING COMMUNITY CONNECTION, PHYSICAL HEALTH, SELF-REGULATION, SELF-EFFICACY, AND RESILIENCE. ALL PARTICIPANTS VALUED THE COMMUNITY-BASED YOGA STUDIO ENVIRONMENT AND MULTIFACETED STRUCTURE OF THE PROGRAM. PARTICIPANTS REPORTED IMPROVEMENTS IN STRENGTH, BALANCE, FLEXIBILITY, AND ATTENTION CONTROL, AND A GREATER SENSE OF BELONGING, COMMUNITY CONNECTION, AND ABILITY TO MOVE FORWARD WITH THEIR LIVES. PARTICIPANTS REPORTED ONGOING USE OF TOOLS (E.G., BREATHING EXERCISES) TO COPE WITH NEGATIVE EMOTIONS AND STRESS. ABOUT HALF OF PARTICIPANTS SUSTAINED RELATIONSHIPS BUILT DURING LOVEYOURBRAIN YOGA AND FELT MORE CAPABLE OF ACCESSING OTHER ACTIVITIES IN THEIR COMMUNITY.CONCLUSIONS: LOVEYOURBRAIN YOGA SUCCESSFULLY PROMOTED COMMUNITY INTEGRATION FOR PEOPLE WITH TRAUMATIC BRAIN INJURY. IT ALSO FACILITATED DIVERSE AND MEANINGFUL PHYSICAL, PSYCHOLOGICAL, AND SOCIAL HEALTH BENEFITS, WHICH SUGGEST THAT IT MAY BE AN EFFECTIVE MODE OF COMMUNITY-BASED REHABILITATION.IMPLICATIONS FOR REHABILITATIONTRAUMATIC BRAIN INJURY SURVIVORS OFTEN STRUGGLE TO PARTICIPATE IN THEIR COMMUNITY, THE ULTIMATE GOAL OF REHABILITATIONYOGA IS A HOLISTIC THERAPY WITH MANY BENEFITS, YET IS NOT ACCESSIBLE TO THE TRAUMATIC BRAIN INJURY POPULATION AT THE COMMUNITY LEVELPARTICIPANTS IN A COMMUNITY-BASED YOGA WITH PSYCHOEDUCATION INTERVENTION IN SIX STATES EXPERIENCED DIVERSE AND MEANINGFUL PHYSICAL, PSYCHOLOGICAL, AND SOCIAL HEALTH BENEFITSGROUP-BASED YOGA WITH PSYCHOEDUCATION MAY BE AN EFFECTIVE MODE OF COMMUNITY INTEGRATION AND COMMUNITY-BASED REHABILITATION FOR TRAUMATIC BRAIN INJURY SURVIVORS. 2020 12 2763 42 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893. 2021 13 2638 63 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 14 1165 76 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 15 2831 49 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 16 2035 30 TELE-YOGA FOR CHRONIC PAIN: CURRENT STATUS AND FUTURE DIRECTIONS. PAIN IS A PERVASIVE, DEBILITATING DISORDER THAT IS RESISTANT TO LONG-TERM PHARMACOLOGICAL INTERVENTIONS. ALTHOUGH PSYCHOLOGICAL THERAPIES SUCH AS COGNITIVE BEHAVIOR THERAPY DEMONSTRATE MODERATE EFFICACY, MANY INDIVIDUALS CONTINUE TO HAVE ONGOING DIFFICULTIES FOLLOWING TREATMENT. THERE IS A CURRENT TREND TO ESTABLISH COMPLEMENTARY AND INTEGRATIVE HEALTH INTERVENTIONS FOR CHRONIC PAIN, FOR WHICH YOGA HAS BEEN FOUND TO HAVE EXCITING POTENTIAL. NEVERTHELESS, AN IMPORTANT CONSIDERATION WITHIN THE FIELD IS ACCESSIBILITY TO ADEQUATE CARE. TELEHEALTH CAN BE USED TO PROVIDE REAL-TIME INTERACTIVE VIDEO CONFERENCING LEADING TO INCREASED ACCESS TO HEALTH CARE FOR INDIVIDUALS LOCATED REMOTELY OR WHO OTHERWISE HAVE DIFFICULTY ACCESSING SERVICES, PERHAPS THROUGH ISSUES OF MOBILITY OR PROXIMITY OF ADEQUATE SERVICES. THIS ARTICLE ASSESSES THE CURRENT STATUS AND FEASIBILITY OF IMPLEMENTING TELE-YOGA FOR CHRONIC PAIN. METHODOLOGICAL LIMITATIONS AND RECOMMENDATIONS FOR FUTURE RESEARCH ARE DISCUSSED. 2018 17 1161 57 EVALUATING A GROUP-BASED YOGA OF STRESS RESILIENCE PROGRAMME: A PRAGMATIC BEFORE-AFTER INTERVENTIONAL STUDY PROTOCOL. INTRODUCTION: RATES OF MENTAL HEALTH ILLNESSES AND BURNOUT ARE INCREASING INTERNATIONALLY. THERAPEUTIC YOGA IS INCREASINGLY USED TO IMPROVE AND MAINTAIN PHYSICAL, MENTAL AND EMOTIONAL WELL-BEING AND GENERAL HEALTH. THIS PROTOCOL DESCRIBES A STUDY TO EVALUATE THE EFFECTIVENESS OF AN EXISTING PRIMARY CARE GROUP-BASED THERAPEUTIC YOGA PROGRAMME, THE YOGA OF STRESS RESILIENCE PROGRAMME, WHICH COMBINES YOGA AND PSYCHOTHERAPEUTIC TECHNIQUES, IN IMPROVING MENTAL HEALTH AND DECREASING BURNOUT. IMPLEMENTATION FACTORS WILL ALSO BE EVALUATED FOR POTENTIAL SCALE-UP. METHODS AND ANALYSIS: A PRAGMATIC BEFORE-AFTER INTERVENTIONAL TRIAL DESIGN WILL BE USED TO STUDY CHANGES IN OCCUPATIONAL PARTICIPATION AND MENTAL HEALTH OUTCOMES, INCLUDING ANXIETY, DEPRESSION, BURNOUT, FUNCTIONAL IMPAIRMENT, INSOMNIA, PERCEIVED STRESS, LONELINESS, SELF-COMPASSION AND READINESS FOR CHANGE IN ADULTS EXPERIENCING ANXIETY AND BURNOUT. REPEATED MEASURES ANALYSIS OF VARIANCE WILL BE USED TO DETERMINE CHANGES IN OUTCOME MEASURES OVER TIME. REGRESSION AND MULTIVARIATE ANALYSES WILL BE CONDUCTED TO EXAMINE RELATIONSHIPS BETWEEN PARTICIPANT CHARACTERISTICS AND OUTCOMES AND AMONG VARIOUS OUTCOMES. THE REACH, EFFECTIVENESS, ADOPTION, IMPLEMENTATION, AND MAINTENANCE FRAMEWORK WILL BE USED TO GUIDE THE ANALYSES. ETHICS AND DISSEMINATION: APPROVAL FROM THE HAMILTON INTEGRATED RESEARCH ETHICS BOARD HAS BEEN WAIVED: PROJECT NUMBER 7082 (FULL REVIEW WAIVED). INFORMED CONSENT WILL BE OBTAINED PRIOR TO ENROLLING ANY PARTICIPANT INTO THE STUDY. ALL DATA WILL BE KEPT CONFIDENTIAL. PEER-REVIEWED PUBLICATIONS AND PRESENTATIONS WILL TARGET RESEARCHERS AND HEALTH PROFESSIONALS. TRIAL REGISTRATION NUMBER: THE CLINICALTRIALS.GOV REGISTRY (NCT03973216). 2020 18 258 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 19 2130 48 THE EFFECTIVENESS OF YOGA TO PREVENT DIABETES MELLITUS TYPE 2: A PROTOCOL FOR SYSTEMATIC REVIEW AND META-ANALYSIS. BACKGROUND: TYPE 2 DIABETES MELLITUS (T2DM) IS BECOMING A LEADING PROBLEM WORLDWIDE. EMERGING REPORTS REVEAL ALARMING EVIDENCE OF INCREASING PREVALENCE OF T2DM THAT HAS REACHED PANDEMIC LEVELS. DESPITE THE SIGNIFICANT INCIDENCE, THERE ARE LIMITED RELIABLE DATA RESOURCES AND COMPREHENSIVE SYSTEMATIC REVIEW AND META-ANALYSIS ON THE EFFECTS OF YOGA ON PEOPLE WHO ARE A PREDIABETIC OR HIGH RISK FOR DEVELOPING T2DM. OBJECTIVE: THE OBJECTIVE OF THIS PROTOCOL IS TO CONDUCT A FULL-SCALE SYSTEMATIC REVIEW AND META-ANALYSES ON THE EFFECTS OF YOGA ON PEOPLE WHO ARE PREDIABETES OR HIGH RISK OF DEVELOPING T2DM. METHODS: THE ARTICLES ENROLLED IN THE STUDY WILL BE RETRIEVED FROM THE ONLINE DATABASES BETWEEN 2002 AND THE DATE THE SEARCHES ARE EXECUTED. THE SEARCHES WILL BE REPEATED JUST BEFORE THE FINAL ANALYSES AND FURTHER RELEVANT STUDIES FOR INCLUSION. WE WILL CONDUCT A BIBLIOGRAPHIC SEARCH IN DATABASES: MEDLINE/PUBMED, SCOPUS, COCHRANE LIBRARY, EBSCO, AND INDMED USING KEYWORDS INCLUDING PREDIABETES STATE, HIGH RISK FOR DIABETES, METABOLIC SYNDROME, AND YOGA. A DEFINED SEARCH STRATEGY WILL BE IMPLEMENTED ALONG WITH SELECTION CRITERIA TO OBTAIN FULL-TEXT ARTICLES OF RELEVANT STUDIES. THIS STUDY PROTOCOL WAS PREPARED ACCORDING TO THE PREFERRED REPORTING ITEMS FOR SYSTEMATIC REVIEWS AND META-ANALYSIS FOR PROTOCOLS 2015 GUIDELINES. THERE WILL BE NO LANGUAGE RESTRICTIONS. ETHICS AND DISSEMINATION: THE PROPOSED STUDY WILL BE BASED ON PUBLISHED STUDIES AND PUBLICLY AVAILABLE ANONYMIZED DATA WITHOUT DIRECTLY INVOLVING HUMAN PARTICIPANTS AND THEREFORE REQUIRES NEITHER FORMAL HUMAN ETHICAL REVIEW NOR APPROVAL BY A HUMAN RESEARCH ETHICS COMMITTEE. WE PUBLISHED AN OUTLINE OF THE PROTOCOL IN THE INTERNATIONAL PROSPECTIVE REGISTER OF SYSTEMATIC REVIEWS (PROSPERO) IN 2018. WE PLAN TO DISSEMINATE THE FINDINGS OF THIS SYSTEMATIC REVIEW AND META-ANALYSIS THROUGH PUBLICATION IN A PEER-REVIEWED JOURNAL AND PRESENTATION AT RELEVANT CONFERENCE PROCEEDINGS. IN ADDITION, WE BELIEVE THE RESULTS OF THE SYSTEMATIC REVIEW WILL HAVE IMPLICATIONS FOR POLICY AND PRACTICE. WE WILL PREPARE POLICYMAKER SUMMARY USING A VALIDATED FORMAT, DISSEMINATE THROUGH SOCIAL MEDIA AND EMAIL DISCUSSION GROUPS. REVIEW REGISTRATION NUMBER: PROSPERO REGISTRATION NUMBER CRD 42018106657. 2019 20 1404 51 IMPACT OF YOGA ON COGNITION AND MENTAL HEALTH AMONG ELDERLY: A SYSTEMATIC REVIEW. BACKGROUND: COGNITIVE DECLINE AND PSYCHOLOGICAL HEALTH PROBLEMS ARE THE MOST FREQUENTLY OBSERVED AND UNDER-TREATED ISSUES AMONG THE ELDERLY. MANY STUDIES HAVE ASSESSED THE EFFICACY OF YOGA ON COGNITIVE AND MENTAL HEALTH PARAMETERS AMONG THE ELDERLY. HOWEVER, UP TO DATE, THERE IS NO SYSTEMATIC REVIEW DONE TO EVALUATE THE ROLE OF YOGA-BASED INTERVENTIONS ON COGNITION AND MENTAL HEALTH IN THE ELDERLY. OBJECTIVE: THIS REVIEW EVALUATES THE BENEFICIAL EFFECT OF YOGA IN IMPROVING COGNITIVE AND MENTAL HEALTH IN THE ELDERLY. METHODOLOGY: A COMPREHENSIVE SEARCH HAS PERFORMED ON MEDLINE, GOOGLE SCHOLAR, PUBMED, AND PSYCINFO ELECTRONIC DATABASE FROM THEIR INCEPTION TO JANUARY 2019. THE LITERATURE SEARCH WAS CONSTRUCTED AROUND SEARCH TERM FOR "MENTAL HEALTH", "COGNITION", "YOGA" AND "ELDERLY". OUT OF 3388 RECORDS, WE WERE CONSIDERED ONLY RANDOMIZED CONTROL TRIALS (RCTS) WITH YOGA-BASED INTERVENTIONS ON THE OLDER PEOPLE FOR THIS REVIEW. RISK OF BIAS WAS ASSESSED USING DELPHI LIST AND PEDRO CRITERIA. RESULTS: AFTER FILTERING OUT IRRELEVANT STUDIES, IN OUR SEARCH, WE COME ACROSS 13 RCTS, AND THEY INCLUDED IN THIS SYSTEMATIC REVIEW. OF 13 RCTS, FOUR STUDIES ASSESSED ONLY COGNITIVE PARAMETERS AND FIVE STUDIES ASSESSED ONLY PSYCHOLOGICAL PARAMETERS, AND FOUR STUDIES EVALUATED BOTH. STUDY QUALITY WAS FAIR TO MODERATE OF INCLUDED RCTS ON THE DELPHI LIST AND PEDRO CRITERIA. MAXIMUM STUDIED VARIABLES IN COGNITION WERE EXECUTIVE FUNCTIONS, MEMORY, ATTENTION, AND LANGUAGE WHILE IN MENTAL HEALTH DEPRESSION, ANXIETY, STRESS, AND MOOD. YOGA-BASED INTERVENTIONS HAVE SOME BENEFICIAL EFFECTS ON ATTENTION, EXECUTIVE FUNCTIONS AMONG COGNITIVE VARIABLES, AND DEPRESSION AMONG MENTAL HEALTH PARAMETERS AMONG THE ELDERLY. CONCLUSION: THE PRESENT REVIEW INDICATES THAT YOGA-BASED INTERVENTIONS HAVE SOME POSITIVE EVIDENCE IN IMPROVING ATTENTION, EXECUTIVE FUNCTIONS AND MEMORY OF COGNITION, WHILE DEPRESSION IN MENTAL HEALTH COMPARED TO ACTIVE CONTROL AMONG THE ELDERLY. HOWEVER, METHODOLOGICAL LIMITATIONS AND SMALL NUMBER OF STUDIES PRECLUDE CONFIRMING THE POTENTIAL BENEFITS OF YOGA-BASED INTERVENTIONS ON COGNITION AND MENTAL HEALTH AMONG THE ELDERLY. FURTHER, THIS REVIEW STRONGLY RECOMMENDS MORE RANDOMIZED CONTROL TRIALS WITH STANDARD STUDY METHODOLOGY, USE OF VALIDATED MODULES OF YOGA INTERVENTION, AND LONG TERM FOLLOW UP TO HAVE DEFINITE CONCLUSIONS. 2020