1 2843 130 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 2 2861 55 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 3 1632 52 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 4 1093 50 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 5 2008 45 STUDY PROTOCOL FOR YOGA-BASED LIFESTYLE INTERVENTION FOR HEALTHY AGEING PHENOTYPE IN THE OLDER ADULTS (YHAP): A TWO-ARMED, WAITLIST RANDOMISED CONTROLLED TRIAL WITH MULTIPLE PRIMARY OUTCOMES. INTRODUCTION: THE CONCEPTUALISATION OF HEALTHY AGEING PHENOTYPE (HAP) AND THE AVAILABILITY OF A TENTATIVE PANEL FOR HAP BIOMARKERS RAISE THE NEED TO TEST THE EFFICACY OF POTENTIAL INTERVENTIONS TO PROMOTE HEALTH IN OLDER ADULTS. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 24-WEEK PROGRAMME TO EXPLORE THE HOLISTIC INFLUENCE OF THE YOGA-BASED INTERVENTION ON THE (BIO)MARKERS OF HAP. METHODS AND ANALYSIS: THE STUDY IS A TWO-ARMED, RANDOMISED WAITLIST CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS AND MULTIPLE PRIMARY OUTCOMES. WE AIM TO RECRUIT 250 SUBJECTS, AGED 60-80 YEARS FROM THE RESIDENTIAL COMMUNITIES AND OLD AGE CLUBS IN BANGALORE CITY, INDIA, WHO WILL UNDERGO RANDOMISATION INTO INTERVENTION OR CONTROL ARMS (1:1). THE INTERVENTION WILL INCLUDE A YOGA-BASED PROGRAMME TAILORED FOR THE OLDER ADULTS, 1 HOUR PER DAY FOR 6 DAYS A WEEK, SPREAD FOR 24 WEEKS. DATA WOULD BE COLLECTED AT THE BASELINE AND POST-INTERVENTION, THE 24TH WEEK. THE MULTIPLE PRIMARY OUTCOMES OF THE STUDY ARE THE (BIO)MARKERS OF HAP: GLYCATED HAEMOGLOBIN, LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C), SYSTOLIC BLOOD PRESSURE, AND FORCED EXPIRATORY VOLUME IN 1 S FOR PHYSIOLOGICAL AND METABOLIC HEALTH; DIGIT SYMBOL SUBSTITUTION TEST, TRAIL MAKING TESTS A AND B FOR COGNITION; HAND GRIP STRENGTH AND GAIT SPEED FOR PHYSICAL CAPABILITY; LONELINESS FOR SOCIAL WELL-BEING AND WHO QUALITY OF LIFE INSTRUMENT-SHORT FORM FOR QUALITY OF LIFE. THE SECONDARY OUTCOMES INCLUDE INFLAMMATORY MARKERS, TUMOUR NECROSIS FACTOR-ALPHA RECEPTOR II, C REACTIVE PROTEIN, INTERLEUKIN 6 AND SERUM KLOTHO LEVELS. ANALYSES WILL BE BY INTENTION-TO-TREAT AND THE HOLISTIC IMPACT OF YOGA ON HAP WILL BE ASSESSED USING GLOBAL STATISTICAL TEST. ETHICS AND DISSEMINATION: THE STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA UNIVERSITY, BANGALORE (ID: RES/IEC-SVYASA/143/2019). WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373. 2021 6 1345 42 HYPERTENSION ANALYSIS OF STRESS REDUCTION USING MINDFULNESS MEDITATION AND YOGA (THE HARMONY STUDY): STUDY PROTOCOL OF A RANDOMISED CONTROL TRIAL. INTRODUCTION: HYPERTENSION (HTN) IS A LEADING RISK FACTOR FOR PREVENTABLE CARDIOVASCULAR DISEASE, WITH OVER ONE IN FIVE ADULTS AFFECTED WORLDWIDE. LIFESTYLE MODIFICATION IS A KEY STRATEGY FOR THE PREVENTION AND TREATMENT OF HTN. STRESS HAS BEEN ASSOCIATED WITH GREATER CARDIOVASCULAR RISK, AND STRESS MANAGEMENT IS A RECOMMENDED INTERVENTION FOR HYPERTENSIVES. STRESS REDUCTION THROUGH RELAXATION THERAPIES HAS BEEN SHOWN TO HAVE AN EFFECT ON HUMAN PHYSIOLOGY, INCLUDING LOWERING BLOOD PRESSURE (BP). HOWEVER, INDIVIDUALISED BEHAVIOURAL INTERVENTIONS ARE RESOURCE INTENSIVE, AND GROUP STRESS MANAGEMENT APPROACHES HAVE NOT BEEN VALIDATED FOR REDUCING HTN. THE HARMONY STUDY IS A PILOT RANDOMISED CONTROLLED TRIAL DESIGNED TO DETERMINE IF MINDFULNESS-BASED STRESS REDUCTION (MBSR), A STANDARDISED GROUP THERAPY, IS AN EFFECTIVE INTERVENTION FOR LOWERING BP IN STAGE 1 UNMEDICATED HYPERTENSIVES. METHODS AND ANALYSIS: MEN AND WOMEN UNMEDICATED FOR HTN WITH MEAN DAYTIME AMBULATORY BLOOD PRESSURE (ABP) >/=135/85 MM HG OR 24 H ABP >/=130/80 MM HG ARE INCLUDED IN THE STUDY. SUBJECTS ARE RANDOMISED TO RECEIVE MBSR IMMEDIATELY OR AFTER A WAIT-LIST CONTROL PERIOD. THE PRIMARY OUTCOME MEASURE IS MEAN AWAKE AND 24 H ABP. THE PRIMARY OBJECTIVE OF THE HARMONY STUDY IS TO COMPARE ABP BETWEEN THE TREATMENT AND WAIT-LIST CONTROL ARM AT THE 12-WEEK PRIMARY ASSESSMENT PERIOD. RESULTS FROM THIS STUDY WILL DETERMINE IF MBSR IS AN EFFECTIVE INTERVENTION FOR LOWERING BP IN EARLY UNMEDICATED HYPERTENSIVES. ETHICS AND DISSEMINATION: THIS RESEARCH PROJECT WAS APPROVED BY THE SUNNYBROOK RESEARCH ETHICS BOARD AND THE UNIVERSITY HEALTH NETWORK RESEARCH ETHICS BOARD (TORONTO, CANADA). PLANNED ANALYSES ARE IN FULL COMPLIANCE WITH THE PRINCIPLES OF THE DECLARATION OF HELSINKI. DATA COLLECTION WILL BE COMPLETED BY EARLY SPRING 2012. PRIMARY AND SECONDARY ANALYSIS WILL COMMENCE IMMEDIATELY AFTER DATA MONITORING IS COMPLETED; DISSEMINATION PLANS INCLUDE PREPARING PUBLICATIONS FOR SUBMISSION DURING THE SUMMER OF 2012. TRIAL REGISTRATION NUMBER: THIS STUDY IS REGISTERED WITH HTTP://CLINICALTRIALS.GOV (NCT00825526). 2012 7 2130 36 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 8 2764 46 YOGA PROGRAMME FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH RISK PEOPLE IN INDIA: A MULTICENTRE FEASIBILITY RANDOMISED CONTROLLED TRIAL PROTOCOL. INTRODUCTION: A HUGE POPULATION IN INDIA IS AT HIGH RISK OF TYPE-2 DIABETES (T2DM). PHYSICAL ACTIVITY AND A HEALTHY DIET (HEALTHY LIFESTYLE) IMPROVE BLOOD GLUCOSE LEVELS IN PEOPLE AT HIGH RISK OF T2DM. HOWEVER, AN UNHEALTHY LIFESTYLE IS COMMON AMONG INDIANS. YOGA COVERS PHYSICAL ACTIVITY AND A HEALTHY DIET AND CAN HELP TO PREVENT T2DM. THE RESEARCH QUESTION TO BE ADDRESSED BY THE MAIN RANDOMISED CONTROLLED TRIAL (RCT) IS WHETHER A YOGA PROGRAMME FOR T2DM PREVENTION (YOGA-DP) IS EFFECTIVE IN PREVENTING T2DM AMONG HIGH RISK PEOPLE IN INDIA AS COMPARED WITH ENHANCED STANDARD CARE. IN THIS CURRENT STUDY, WE ARE DETERMINING THE FEASIBILITY OF UNDERTAKING THE MAIN RCT. INTERVENTION: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAMME. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES) AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. METHODS AND ANALYSIS: THIS IS A MULTICENTRE, TWO-ARM, PARALLEL-GROUP, FEASIBILITY RCT WITH BLINDED OUTCOME ASSESSMENT AND INTEGRATED MIXED-METHODS PROCESS EVALUATION. ELIGIBLE PARTICIPANTS SHOULD BE AGED 18-74 YEARS, AT HIGH RISK OF T2DM (FASTING PLASMA GLUCOSE LEVEL 5.6-6.9 MMOL/L) AND SAFE TO PARTICIPATE IN PHYSICAL ACTIVITIES. AT LEAST 64 PARTICIPANTS WILL BE RANDOMISED TO INTERVENTION OR CONTROL GROUP WITH FINAL FOLLOW-UP AT 6 MONTHS. IMPORTANT PARAMETERS, NEEDED TO DESIGN THE MAIN RCT, WILL BE ESTIMATED, SUCH AS SD OF THE OUTCOME MEASURE (FASTING PLASMA GLUCOSE LEVEL AT 6-MONTH FOLLOW-UP), RECRUITMENT, INTERVENTION ADHERENCE, FOLLOW-UP, POTENTIAL CONTAMINATION AND TIME NEEDED TO CONDUCT THE STUDY. SEMISTRUCTURED QUALITATIVE INTERVIEWS WILL BE CONDUCTED WITH UP TO 20-30 PARTICIPANTS, A SAMPLE OF THOSE DECLINING TO PARTICIPATE, FOUR YOGA-DP INSTRUCTORS AND AROUND EIGHT STUDY STAFF TO EXPLORE THEIR PERCEPTIONS AND EXPERIENCES OF TAKING PART IN THE STUDY AND OF THE INTERVENTION, REASONS BEHIND NON-PARTICIPATION, EXPERIENCES OF DELIVERING THE INTERVENTION AND RUNNING THE STUDY, RESPECTIVELY. ETHICS AND DISSEMINATION: ETHICS APPROVAL HAS BEEN OBTAINED FROM THE FOLLOWING RESEARCH ETHICS COMMITTEES: FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITY OF NOTTINGHAM (UK); CENTRE FOR CHRONIC DISEASE CONTROL (CCDC, INDIA); BAPU NATURE CURE HOSPITAL AND YOGASHRAM (BNCHY, INDIA) AND SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA (S-VYASA, INDIA). THE RESULTS WILL BE WIDELY DISSEMINATED AMONG KEY STAKEHOLDERS THROUGH VARIOUS AVENUES. TRIAL REGISTRATION NUMBER: CTRI/2019/05/018893. 2020 9 1161 37 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 10 2389 46 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823. 2020 11 888 51 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 12 2121 34 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 13 1591 49 MEDITATION AND YOGA FOR IRRITABLE BOWEL SYNDROME: STUDY PROTOCOL FOR A RANDOMISED CLINICAL TRIAL (MY-IBS STUDY). INTRODUCTION: WHEN DELIVERED IN PERSON, YOGA HAS BEEN SHOWN TO BE EFFECTIVE IN MANAGING IRRITABLE BOWEL SYNDROME (IBS) SYMPTOMS. RESEARCH IS NEEDED TO TEST THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC OPTION WHEN DELIVERED VIRTUALLY. THE PRIMARY AIM OF THE MIND AND YOGA FOR IBS RANDOMISED CONTROLLED TRIAL IS TO DETERMINE THE EFFECTS OF AN 8-WEEK VIRTUAL MEDITATION AND YOGA INTERVENTION ON IBS SYMPTOM SEVERITY COMPARED WITH AN ADVICE-ONLY ACTIVE CONTROL GROUP. METHODS AND ANALYSIS: ADULTS DIAGNOSED WITH IBS WILL BE RANDOMISED TO RECEIVE EITHER A UPA YOGA INTERVENTION OR AN ADVICE-ONLY CONTROL GROUP. THE INTERVENTION WILL CONSIST OF WEEKLY ONLINE CLASSES FOR 8 WEEKS DELIVERED BY A FACILITATOR USING MICROSOFT OFFICE TEAMS AND DAILY HOME PRACTICE. FEASIBILITY WILL BE EVALUATED BY EXAMINING RECRUITMENT AND ATTRITION RATES, ADHERENCE, PARTICIPANT SATISFACTION WITH THE PROGRAMME AND SAFETY. THE PRIMARY OUTCOME IS IBS SYMPTOM SEVERITY, AND KEY SECONDARY OUTCOMES INCLUDE (BUT NOT LIMITED TO) QUALITY OF LIFE, ANXIETY AND DEPRESSION SYMPTOMS, COVID-19-RELATED STRESS AND ANXIETY, AND FATIGUE. OUTCOMES WILL BE ASSESSED AT BASELINE, 4 WEEKS AND 8 WEEKS. AN EMBEDDED DESIGN EXPERIMENTAL MODEL SUBSTUDY WILL BE CONDUCTED POST INTERVENTION USING QUALITATIVE RESEARCH METHODS TO IDENTIFY PARTICIPANTS' EXPERIENCES IN THE YOGA PROGRAMME. ETHICS AND DISSEMINATION: THIS STUDY HAS BEEN APPROVED BY THE CONJOINT HEALTH RESEARCH ETHICS BOARD (REB ID 20-0084). FINDINGS WILL BE DISSEMINATED THROUGH PEER-REVIEWED PUBLICATION, CONFERENCE PRESENTATION AND SOCIAL MEDIA. TRIAL REGISTRATION NUMBER: NCT04302623. 2022 14 2831 38 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 15 258 44 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 16 613 26 DEVELOPMENT OF A YOGA PROGRAM FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. INTRODUCTION: MANY INDIANS ARE AT HIGH-RISK OF TYPE-2 DIABETES MELLITUS (T2DM). YOGA IS AN ANCIENT INDIAN MIND-BODY DISCIPLINE, THAT HAS BEEN ASSOCIATED WITH IMPROVED GLUCOSE LEVELS AND CAN HELP TO PREVENT T2DM. THE STUDY AIMED TO SYSTEMATICALLY DEVELOP A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA USING A COMPLEX INTERVENTION DEVELOPMENT APPROACH. MATERIALS AND METHODS: AS PART OF THE INTERVENTION, WE DEVELOPED A BOOKLET AND A HIGH-DEFINITION VIDEO FOR PARTICIPANTS AND A MANUAL FOR YOGA-DP INSTRUCTORS. A SYSTEMATIC ITERATIVE PROCESS WAS FOLLOWED TO DEVELOP THE INTERVENTION AND INCLUDED FIVE STEPS: (I) A SYSTEMATIC REVIEW OF THE LITERATURE TO GENERATE A LIST OF YOGIC PRACTICES THAT IMPROVES BLOOD GLUCOSE LEVELS AMONG ADULTS AT HIGH-RISK OF OR WITH T2DM, (II) VALIDATION OF IDENTIFIED YOGIC PRACTICES BY YOGA EXPERTS, (III) DEVELOPMENT OF THE INTERVENTION, (IV) CONSULTATION WITH YOGA, EXERCISE, PHYSICAL ACTIVITY, DIET, BEHAVIOR CHANGE, AND/OR DIABETES EXPERTS ABOUT THE INTERVENTION, AND (V) PRETEST THE INTERVENTION AMONG YOGA PRACTITIONERS AND LAY PEOPLE (THOSE AT RISK OF T2DM AND HAD NOT PRACTICED YOGA BEFORE) IN INDIA. RESULTS: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAM, PROVIDED OVER A PERIOD OF 24 WEEKS. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES), AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. ONCE PARTICIPANTS COMPLETE THE PROGRAM, THEY ARE STRONGLY ENCOURAGED TO MAINTAIN A HEALTHY LIFESTYLE IN THE LONG-TERM. CONCLUSIONS: WE SYSTEMATICALLY DEVELOPED A NOVEL YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. A MULTI-CENTER FEASIBILITY RANDOMIZED CONTROLLED TRIAL IS IN PROGRESS IN INDIA. 2020 17 319 46 AN INTERVENTION WITH DANCE AND YOGA FOR GIRLS WITH FUNCTIONAL ABDOMINAL PAIN DISORDERS (JUST IN TIME): PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: FUNCTIONAL ABDOMINAL PAIN DISORDERS (FAPDS) AFFECT MANY CHILDREN WORLDWIDE, PREDOMINANTLY GIRLS, AND CAUSE CONSIDERABLE LONG-TERM NEGATIVE CONSEQUENCES FOR INDIVIDUALS AND SOCIETY. EVIDENCE-BASED AND COST-EFFECTIVE TREATMENTS ARE THEREFORE STRONGLY NEEDED. PHYSICAL ACTIVITY HAS SHOWN PROMISING EFFECTS IN THE PRACTICAL MANAGEMENT OF FAPDS. DANCE AND YOGA ARE BOTH POPULAR ACTIVITIES THAT HAVE BEEN SHOWN TO PROVIDE SIGNIFICANT PSYCHOLOGICAL AND PAIN-RELATED BENEFITS WITH MINIMAL RISK. THE ACTIVITIES COMPLEMENT EACH OTHER, IN THAT DANCE INVOLVES DYNAMIC, RHYTHMIC PHYSICAL ACTIVITY, WHILE YOGA ENHANCES RELAXATION AND FOCUS. OBJECTIVE: THIS STUDY AIMS TO EVALUATE THE EFFECTS OF A DANCE AND YOGA INTERVENTION AMONG GIRLS AGED 9 TO 13 YEARS WITH FAPDS. METHODS: THE STUDY IS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AMONG GIRLS AGED 9 TO 13 YEARS WITH FUNCTIONAL ABDOMINAL PAIN, IRRITABLE BOWEL SYNDROME, OR BOTH. THE TARGET SAMPLE SIZE WAS 150 GIRLS RANDOMIZED INTO 2 ARMS: AN INTERVENTION ARM THAT RECEIVES DANCE AND YOGA SESSIONS TWICE WEEKLY FOR 8 MONTHS AND A CONTROL ARM THAT RECEIVES STANDARD CARE. OUTCOMES WILL BE MEASURED AT BASELINE AND AFTER 4, 8, 12, AND 24 MONTHS, AND LONG-TERM FOLLOW-UP WILL BE CONDUCTED 5 YEARS FROM BASELINE. QUESTIONNAIRES, INTERVIEWS, AND BIOMARKER MEASURES, SUCH AS CORTISOL IN SALIVA AND FECAL MICROBIOTA, WILL BE USED. THE PRIMARY OUTCOME IS THE PROPORTION OF GIRLS IN EACH GROUP WITH REDUCED PAIN, AS MEASURED BY THE FACES PAIN SCALE-REVISED IN A PAIN DIARY, IMMEDIATELY AFTER THE INTERVENTION. SECONDARY OUTCOMES ARE GASTROINTESTINAL SYMPTOMS, GENERAL HEALTH, MENTAL HEALTH, STRESS, AND PHYSICAL ACTIVITY. THE STUDY ALSO INCLUDES QUALITATIVE EVALUATIONS AND HEALTH ECONOMIC ANALYSES. THIS STUDY WAS APPROVED BY THE REGIONAL ETHICAL REVIEW BOARD IN UPPSALA (NO. 2016/082 1-2). RESULTS: DATA COLLECTION BEGAN IN OCTOBER 2016. THE INTERVENTION HAS BEEN PERFORMED IN 3 PERIODS FROM 2016 THROUGH 2019. THE FINAL 5-YEAR FOLLOW-UP IS ANTICIPATED TO BE COMPLETED BY FALL 2023. CONCLUSIONS: COST-EFFECTIVE AND EASILY ACCESSIBLE INTERVENTIONS ARE WARRANTED TO REDUCE THE NEGATIVE CONSEQUENCES ARISING FROM FAPDS IN YOUNG GIRLS. PHYSICAL ACTIVITY IS AN EFFECTIVE STRATEGY, BUT INTERVENTION STUDIES ARE NEEDED TO BETTER UNDERSTAND WHAT TYPES OF ACTIVITIES FACILITATE REGULAR PARTICIPATION IN THIS TARGET GROUP. THE JUST IN TIME (TRY, IDENTIFY, MOVE, AND ENJOY) STUDY WILL PROVIDE INSIGHTS REGARDING THE EFFECTIVENESS OF DANCE AND YOGA AND IS ANTICIPATED TO CONTRIBUTE TO THE CHALLENGING WORK OF REDUCING THE BURDEN OF FAPDS FOR YOUNG GIRLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV (NCT02920268); HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT02920268. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19748. 2020 18 2763 29 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 19 1165 48 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 20 2638 40 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