1 900 158 EFFECTIVENESS AND COST-EFFECTIVENESS OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAM FOLLOWING ACUTE MYOCARDIAL INFARCTION: STUDY RATIONALE AND DESIGN OF A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CARDIAC REHABILITATION (CR) IS A STANDARD TREATMENT FOR SECONDARY PREVENTION OF ACUTE MYOCARDIAL INFARCTION (AMI) IN HIGH INCOME COUNTRIES (HICS), BUT IT IS INACCESSIBLE TO MOST PATIENTS IN INDIA DUE TO HIGH COSTS AND SKILLS REQUIRED FOR MULTIDISCIPLINARY CR TEAMS. WE DEVELOPED A LOW-COST AND SCALABLE CR PROGRAM BASED ON CULTURALLY-ACCEPTABLE PRACTICE OF YOGA (YOGA-CARE). IN THIS PAPER, WE REPORT THE RATIONALE AND DESIGN FOR EVALUATION OF ITS EFFECTIVENESS AND COST-EFFECTIVENESS. METHODS: THIS IS A MULTI-CENTER, SINGLE-BLIND, TWO-ARM PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL ACROSS 22 CARDIAC CARE HOSPITALS IN INDIA. FOUR THOUSAND PATIENTS AGED 18-80YEARS WITH AMI WILL BE RECRUITED AND RANDOMIZED 1:1 TO RECEIVE YOGA-CARE PROGRAM (13 SESSIONS SUPERVISED BY AN INSTRUCTOR AND ENCOURAGEMENT TO SELF-PRACTICE DAILY) OR ENHANCED STANDARD CARE (3 SESSIONS OF HEALTH EDUCATION) DELIVERED OVER A PERIOD OF THREE MONTHS. PARTICIPANTS WILL BE FOLLOWED 3-MONTHLY TILL THE END OF THE TRIAL. THE CO-PRIMARY OUTCOMES ARE A) TIME TO OCCURRENCE OF FIRST CARDIOVASCULAR EVENT (COMPOSITE OF ALL-CAUSE MORTALITY, NON-FATAL MYOCARDIAL INFARCTION, NON-FATAL STROKE AND EMERGENCY CARDIOVASCULAR HOSPITALIZATION), AND B) QUALITY OF LIFE (EURO-QOL-5L) AT 12WEEKS. SECONDARY OUTCOMES INCLUDE NEED FOR REVASCULARIZATION PROCEDURES, RETURN TO PRE-INFARCT ACTIVITIES, TOBACCO CESSATION, MEDICATION ADHERENCE, AND COST-EFFECTIVENESS OF THE INTERVENTION. CONCLUSION: THIS TRIAL WILL ALONE CONTRIBUTE >20% PARTICIPANTS TO EXISTING META-ANALYSES OF RANDOMIZED TRIALS OF CR WORLDWIDE. IF YOGA-CARE IS FOUND TO BE EFFECTIVE, IT HAS THE POTENTIAL TO SAVE MILLIONS OF LIVES AND TRANSFORM CARE OF AMI PATIENTS IN INDIA AND OTHER LOW AND MIDDLE INCOME COUNTRY SETTINGS. 2019 2 614 52 DEVELOPMENT OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAMME FOR SECONDARY PREVENTION OF MYOCARDIAL INFARCTION. CARDIAC REHABILITATION (CR) AFTER MYOCARDIAL INFARCTION IS HIGHLY EFFECTIVE. IT IS UNAVAILABLE IN PUBLIC HOSPITALS IN INDIA DUE TO LIMITED RESOURCES. OUR OBJECTIVE WAS TO DEVELOP A SCALABLE MODEL OF CR FOR INDIA BASED ON YOGA, WHICH COULD ALSO APPEAL TO SOME GROUPS WITH LOW UPTAKE OF CR (E.G., ETHNIC MINORITIES, WOMEN, AND OLDER PEOPLE) GLOBALLY. THE INTERVENTION WAS DEVELOPED USING A STRUCTURED PROCESS. A LITERATURE REVIEW AND CONSULTATIONS WITH YOGA EXPERTS, CR EXPERTS, AND POSTMYOCARDIAL INFARCTION PATIENTS WERE CONDUCTED TO SYSTEMATICALLY IDENTIFY AND SHORTLIST APPROPRIATE YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, MEDITATION AND RELAXATION PRACTICES, AND LIFESTYLE CHANGES, WHICH WERE INCORPORATED INTO A CONVENTIONAL CR FRAMEWORK. THE DRAFT INTERVENTION WAS FURTHER REFINED BASED ON THE FEEDBACK FROM AN INTERNAL STAKEHOLDER GROUP AND AN EXTERNAL PANEL OF INTERNATIONAL EXPERTS, BEFORE BEING PILOTED WITH YOGA INSTRUCTORS AND PATIENTS WITH MYOCARDIAL INFARCTION. A FOUR-PHASE YOGA-BASED CR (YOGA-CARE) PROGRAMME WAS DEVELOPED FOR DELIVERY BY A SINGLE YOGA INSTRUCTOR WITH BASIC TRAINING. THE PROGRAMME CONSISTS OF A TOTAL OF 13 INSTRUCTOR-LED SESSIONS (2 INDIVIDUAL AND 11 GROUP) OVER A 3-MONTH PERIOD. GROUP SESSIONS INCLUDE GUIDED PRACTICE OF YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, AND MEDITATION AND RELAXATION PRACTICES, AND SUPPORT FOR THE LIFESTYLE CHANGE AND COPING THROUGH A MODERATED DISCUSSION. PATIENTS ARE ENCOURAGED TO SELF-PRACTICE DAILY AT HOME AND CONTINUE LONG-TERM WITH THE HELP OF A BOOKLET AND DIGITAL VIDEO DISC (DVD). FAMILY MEMBERS/CARERS ARE ENCOURAGED TO JOIN THROUGHOUT. IN CONCLUSION, A NOVEL YOGA-BASED CR PROGRAMME HAS BEEN DEVELOPED, WHICH PROMISES TO PROVIDE A SCALABLE CR SOLUTION FOR INDIA AND AN ALTERNATIVE CHOICE FOR CR GLOBALLY. IT IS CURRENTLY BEING EVALUATED IN A LARGE MULTICENTRE RANDOMISED CONTROLLED TRIAL ACROSS INDIA. 2019 3 2857 70 YOGA-BASED CARDIAC REHABILITATION AFTER ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL. BACKGROUND: GIVEN THE SHORTAGE OF CARDIAC REHABILITATION (CR) PROGRAMS IN INDIA AND POOR UPTAKE WORLDWIDE, THERE IS AN URGENT NEED TO FIND ALTERNATIVE MODELS OF CR THAT ARE INEXPENSIVE AND MAY OFFER CHOICE TO SUBGROUPS WITH POOR UPTAKE (E.G., WOMEN AND ELDERLY). OBJECTIVES: THIS STUDY SOUGHT TO EVALUATE THE EFFECTS OF YOGA-BASED CR (YOGA-CARE) ON MAJOR CARDIOVASCULAR EVENTS AND SELF-RATED HEALTH IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL. METHODS: THE TRIAL WAS CONDUCTED IN 24 MEDICAL CENTERS ACROSS INDIA. THIS STUDY RECRUITED 3,959 PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITH A MEDIAN AND MINIMUM FOLLOW-UP OF 22 AND 6 MONTHS. PATIENTS WERE INDIVIDUALLY RANDOMIZED TO RECEIVE EITHER A YOGA-CARE PROGRAM (N = 1,970) OR ENHANCED STANDARD CARE INVOLVING EDUCATIONAL ADVICE (N = 1,989). THE CO-PRIMARY OUTCOMES WERE: 1) FIRST OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) (COMPOSITE OF ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, STROKE, OR EMERGENCY CARDIOVASCULAR HOSPITALIZATION); AND 2) SELF-RATED HEALTH ON THE EUROPEAN QUALITY OF LIFE-5 DIMENSIONS-5 LEVEL VISUAL ANALOGUE SCALE AT 12 WEEKS. RESULTS: MACE OCCURRED IN 131 (6.7%) PATIENTS IN THE YOGA-CARE GROUP AND 146 (7.4%) PATIENTS IN THE ENHANCED STANDARD CARE GROUP (HAZARD RATIO WITH YOGA-CARE: 0.90; 95% CONFIDENCE INTERVAL [CI]: 0.71 TO 1.15; P = 0.41). SELF-RATED HEALTH WAS 77 IN YOGA-CARE AND 75.7 IN THE ENHANCED STANDARD CARE GROUP (BASELINE-ADJUSTED MEAN DIFFERENCE IN FAVOR OF YOGA-CARE: 1.5; 95% CI: 0.5 TO 2.5; P = 0.002). THE YOGA-CARE GROUP HAD GREATER RETURN TO PRE-INFARCT ACTIVITIES, BUT THERE WAS NO DIFFERENCE IN TOBACCO CESSATION OR MEDICATION ADHERENCE BETWEEN THE TREATMENT GROUPS (SECONDARY OUTCOMES). CONCLUSIONS: YOGA-CARE IMPROVED SELF-RATED HEALTH AND RETURN TO PRE-INFARCT ACTIVITIES AFTER ACUTE MYOCARDIAL INFARCTION, BUT THE TRIAL LACKED STATISTICAL POWER TO SHOW A DIFFERENCE IN MACE. YOGA-CARE MAY BE AN OPTION WHEN CONVENTIONAL CR IS UNAVAILABLE OR UNACCEPTABLE TO INDIVIDUALS. (A STUDY ON EFFECTIVENESS OF YOGA BASED CARDIAC REHABILITATION PROGRAMME IN INDIA AND UNITED KINGDOM; CTRI/2012/02/002408). 2020 4 501 48 COMMUNITY BASED YOGA CLASSES FOR TYPE 2 DIABETES: AN EXPLORATORY RANDOMISED CONTROLLED TRIAL. BACKGROUND: YOGA IS A POPULAR THERAPY FOR DIABETES BUT ITS EFFICACY IS CONTESTED. THE AIM OF THIS STUDY WAS TO EXPLORE THE FEASIBILITY OF RESEARCHING COMMUNITY BASED YOGA CLASSES IN TYPE 2 DIABETES WITH A VIEW TO INFORMING THE DESIGN OF A DEFINITIVE, MULTI-CENTRE TRIAL METHODS: THE STUDY DESIGN WAS AN EXPLORATORY RANDOMISED CONTROLLED TRIAL WITH IN-DEPTH PROCESS EVALUATION. THE SETTING WAS TWO MULTI-ETHNIC BOROUGHS IN LONDON, UK; ONE WITH AVERAGE AND ONE WITH LOW MEAN SOCIO-ECONOMIC DEPRIVATION SCORE. CLASSES WERE HELD AT A SPORTS CENTRE OR GP SURGERY. PARTICIPANTS WERE 59 PEOPLE WITH TYPE 2 DIABETES NOT TAKING INSULIN, RECRUITED FROM GENERAL PRACTICE LISTS OR OPPORTUNISTICALLY BY GENERAL PRACTICE STAFF. THE INTERVENTION GROUP WERE OFFERED 12 WEEKS OF A TWICE-WEEKLY 90-MINUTE YOGA CLASS; THE CONTROL GROUP WAS A WAITING LIST FOR THE YOGA CLASSES. BOTH GROUPS RECEIVED ADVICE AND LEAFLETS ON HEALTHY LIFESTYLE AND WERE ENCOURAGED TO EXERCISE. PRIMARY OUTCOME MEASURE WAS HBA1C. SECONDARY OUTCOME MEASURES INCLUDED ATTENDANCE, WEIGHT, WAIST CIRCUMFERENCE, LIPID LEVELS, BLOOD PRESSURE, UKPDS CARDIOVASCULAR RISK SCORE, DIABETES-RELATED QUALITY OF LIFE (ADDQOL), AND SELF-EFFICACY. PROCESS MEASURES WERE ATTENDANCE AT YOGA SESSIONS, SELF-REPORTED FREQUENCY OF PRACTICE BETWEEN TAUGHT SESSIONS, AND QUALITATIVE DATA (INTERVIEWS WITH PATIENTS AND THERAPISTS, ETHNOGRAPHIC OBSERVATION OF THE YOGA CLASSES, AND ANALYSIS OF DOCUMENTS INCLUDING MINUTES OF MEETINGS, CORRESPONDENCE, AND EXERCISE PLANS). RESULTS: DESPITE BROAD INCLUSION CRITERIA, AROUND TWO-THIRDS OF THE PATIENTS ON GP DIABETIC REGISTERS PROVED INELIGIBLE, AND 90% OF THE REMAINDER DECLINED TO PARTICIPATE. MEAN AGE OF PARTICIPANTS WAS 60 +/- 10 YEARS. ATTENDANCE AT YOGA CLASSES WAS AROUND 50%. NOBODY DID THE EXERCISES REGULARLY AT HOME. YOGA TEACHERS FELT THAT MOST PARTICIPANTS WERE UNSUITABLE FOR 'STANDARD' YOGA EXERCISES BECAUSE OF LIMITED FLEXIBILITY, LACK OF BASIC FITNESS, CO-MORBIDITY, AND LACK OF CONFIDENCE. THERE WAS A SMALL FALL IN HBA1C IN THE YOGA GROUP WHICH WAS NOT STATISTICALLY SIGNIFICANT AND WHICH WAS NOT SUSTAINED SIX MONTHS LATER, AND NO SIGNIFICANT CHANGE IN OTHER OUTCOME MEASURES. CONCLUSION: THE BENEFITS OF YOGA IN TYPE 2 DIABETES SUGGESTED IN SOME PREVIOUS STUDIES WERE NOT CONFIRMED. POSSIBLE EXPLANATIONS (APART FROM LACK OF EFFICACY) INCLUDE RECRUITMENT CHALLENGES; PRACTICAL AND MOTIVATIONAL BARRIERS TO CLASS ATTENDANCE; PHYSICAL AND MOTIVATIONAL BARRIERS TO ENGAGING IN THE EXERCISES; INADEQUATE INTENSITY AND/OR DURATION OF YOGA INTERVENTION; AND INSUFFICIENT PERSONALISATION OF EXERCISES TO INDIVIDUAL NEEDS. ALL THESE FACTORS SHOULD BE CONSIDERED WHEN DESIGNING FUTURE TRIALS. TRIAL REGISTRATION: NATIONAL RESEARCH REGISTER (1410) AND CURRENT CONTROLLED TRIALS (ISRCTN63637211). 2009 5 2763 39 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 6 491 28 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 7 613 41 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 8 131 34 A PRAGMATIC MULTI-CENTRED RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: TRIAL PROTOCOL. UNLABELLED: A SYSTEMATIC REVIEW REVEALED THREE SMALL RANDOMISED CONTROLLED TRIALS OF YOGA FOR LOW BACK PAIN, ALL OF WHICH SHOWED EFFECTS ON BACK PAIN THAT FAVOURED THE YOGA GROUP. TO BUILD ON THESE STUDIES A LARGER TRIAL, WITH LONGER TERM FOLLOW-UP, AND A NUMBER OF DIFFERENT YOGA TEACHERS DELIVERING THE INTERVENTION IS REQUIRED. THIS STUDY PROTOCOL DESCRIBES THE DETAILS OF A RANDOMISED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN, WHICH IS FUNDED BY ARTHRITIS RESEARCH CAMPAIGN (ARC) AND IS BEING CONDUCTED BY THE UNIVERSITY OF YORK. 262 PATIENTS WILL BE RECRUITED FROM GP PRACTICES IN 5 CENTRES IN ENGLAND. PATIENTS WILL BE RANDOMISED TO RECEIVE USUAL CARE OR 12 WEEKLY CLASSES OF YOGA. A YOGA PROGRAMME WILL BE DEVISED THAT CAN BE DELIVERED BY YOGA TEACHERS OF THE TWO MAIN NATIONAL YOGA ORGANISATIONS IN THE UK (BRITISH WHEEL OF YOGA AND IYENGAR YOGA ASSOCIATION (UK)). TRIAL REGISTRATION: CURRENT CONTROLLED TRIALS REGISTRY ISRCTN81079604 (DATE REGISTERED 30/03/2007). 2010 9 2831 40 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 10 2598 44 YOGA FOR OLDER ADULTS WITH MULTIMORBIDITY (THE GENTLE YEARS YOGA TRIAL): STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL. BACKGROUND: MULTIMORBIDITY IS COMMON IN OLDER ADULTS AND ASSOCIATED WITH HIGH LEVELS OF ILLNESS BURDEN AND HEALTHCARE EXPENDITURE. THE EVIDENCE BASE FOR HOW TO MANAGE OLDER ADULTS WITH MULTIMORBIDITY IS WEAK. YOGA MIGHT BE A USEFUL INTERVENTION BECAUSE IT HAS THE POTENTIAL TO IMPROVE HEALTH-RELATED QUALITY OF LIFE, PHYSICAL FUNCTIONING, AND SEVERAL MEDICAL CONDITIONS. THE BRITISH WHEEL OF YOGA'S GENTLE YEARS YOGA(C) (GYY) PROGRAMME WAS DEVELOPED SPECIFICALLY FOR OLDER ADULTS, INCLUDING THOSE WITH CHRONIC MEDICAL CONDITIONS. DATA FROM A PILOT TRIAL SUGGESTED FEASIBILITY OF USING GYY IN THIS POPULATION, BUT ITS EFFECTIVENESS AND COST-EFFECTIVENESS REMAIN UNCERTAIN. METHODS: THIS IS A MULTI-SITE, INDIVIDUALLY RANDOMISED, SUPERIORITY TRIAL WITH AN EMBEDDED PROCESS EVALUATION AND AN ECONOMIC ANALYSIS OF COST-EFFECTIVENESS. THE TRIAL WILL COMPARE AN EXPERIMENTAL STRATEGY OF OFFERING A 12-WEEK GYY PROGRAMME AGAINST A CONTROL STRATEGY OF NO OFFER IN COMMUNITY-DWELLING ADULTS AGED 65 OR OVER WHO HAVE MULTIMORBIDITY, DEFINED AS HAVING TWO OR MORE CHRONIC CONDITIONS FROM A PREDEFINED LIST. THE PRIMARY OUTCOME IS HEALTH-RELATED QUALITY OF LIFE MEASURED USING THE EQ-5D-5L, THE PRIMARY ENDPOINT BEING THE OVERALL DIFFERENCE OVER 12 MONTHS. BOTH GROUPS WILL CONTINUE TO BE ABLE TO ACCESS THEIR USUAL CARE FROM PRIMARY, SECONDARY, COMMUNITY, AND SOCIAL SERVICES. PARTICIPANTS, CARE PROVIDERS, AND YOGA TEACHERS WILL NOT BE BLINDED TO THE ALLOCATED INTERVENTION. OUTCOME MEASURES ARE PRIMARILY SELF-REPORTED. THE ANALYSIS WILL FOLLOW INTENTION-TO-TREAT PRINCIPLES. DISCUSSION: THIS PRAGMATIC RANDOMISED CONTROLLED TRIAL WILL DEMONSTRATE IF THE GYY PROGRAMME IS AN EFFECTIVE, COST-EFFECTIVE, AND VIABLE ADDITION TO THE MANAGEMENT OF OLDER ADULTS WITH MULTIMORBIDITY. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . REGISTERED ON 18 MARCH 2019. 2021 11 2764 53 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 12 1251 35 FEASIBILITY TRIAL OF YOGA PROGRAMME FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA: A QUALITATIVE STUDY TO EXPLORE PARTICIPANTS' TRIAL- AND INTERVENTION-RELATED BARRIERS AND FACILITATORS. YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAMME FOR T2DM PREVENTION (YOGA-DP) AND CONDUCTED A FEASIBILITY RANDOMISED CONTROLLED TRIAL (RCT) AMONG HIGH-RISK PEOPLE IN INDIA. THIS QUALITATIVE STUDY'S OBJECTIVE WAS TO IDENTIFY AND EXPLORE PARTICIPANTS' TRIAL- AND INTERVENTION-RELATED BARRIERS AND FACILITATORS. THE FEASIBILITY TRIAL WAS CONDUCTED AT TWO YOGA CENTRES IN NEW DELHI AND BENGALURU, INDIA. IN THIS QUALITATIVE STUDY, 25 TRIAL PARTICIPANTS (13 INTERVENTION GROUP, 12 CONTROL GROUP) WERE RECRUITED FOR SEMI-STRUCTURED INTERVIEWS. DATA WERE ANALYSED USING DEDUCTIVE LOGIC AND AN INTERPRETATIVE PHENOMENOLOGICAL APPROACH. AMONGST INTERVENTION AND CONTROL PARTICIPANTS, KEY BARRIERS TO TRIAL PARTICIPATION WERE INADEQUATE INFORMATION ABOUT RECRUITMENT AND RANDOMISATION PROCESSES AND THE NEGATIVE INFLUENCE OF NON-PARTICIPANTS. FREE BLOOD TESTS TO AID T2DM PREVENTION, SITE STAFF'S FRIENDLY BEHAVIOUR AND FRIENDS' POSITIVE INFLUENCE FACILITATED TRIAL PARTICIPATION. AMONGST INTERVENTION PARTICIPANTS, READABILITY AND UNDERSTANDING OF THE PROGRAMME BOOKLETS, DISLIKE OF THE YOGA DIARY, POOR QUALITY YOGA MATS, DIFFICULTY IN USING THE PROGRAMME VIDEO, HOUSEHOLD COMMITMENT DURING HOME SESSIONS, UNPLANNED TRAVEL, DIFFICULTY IN PRACTISING YOGA POSES, HESITATION IN ATTENDING PROGRAMME SESSIONS WITH THE YOGA-DP INSTRUCTOR OF THE OPPOSITE SEX AND MIXED-SEX GROUP PROGRAMME SESSIONS WERE KEY BARRIERS TO INTERVENTION PARTICIPATION. ADEQUATE INFORMATION WAS PROVIDED ON T2DM PREVENTION AND SELF-CARE, GOOD VENUE AND OTHER SUPPORT PROVIDED FOR PROGRAMME SESSIONS, YOGA-DP INSTRUCTORS' POSITIVE BEHAVIOUR AND IMPROVEMENTS IN PHYSICAL AND MENTAL WELL-BEING FACILITATED INTERVENTION PARTICIPATION. IN CONCLUSION, WE IDENTIFIED AND EXPLORED PARTICIPANTS' TRIAL- AND INTERVENTION-RELATED BARRIERS AND FACILITATORS. WE IDENTIFIED AN ALMOST EQUAL NUMBER OF BARRIERS (N = 12) AND FACILITATORS (N = 13); HOWEVER, INTERVENTION-RELATED BARRIERS AND FACILITATORS WERE GREATER THAN FOR PARTICIPATING IN THE TRIAL. THESE FINDINGS WILL INFORM THE DESIGN OF THE PLANNED DEFINITIVE RCT DESIGN AND INTERVENTION AND CAN ALSO BE USED TO DESIGN OTHER YOGA INTERVENTIONS AND RCTS. 2022 13 2574 21 YOGA FOR EVERYONE: A QUALITATIVE STUDY OF A COMMUNITY YOGA CLASS FOR PEOPLE WITH DISABILITY. BACKGROUND AND OBJECTIVE: PEOPLE WITH MOBILITY IMPAIRMENTS FACE INCREASED BARRIERS TO PHYSICAL ACTIVITY. THE STUDY AIMED TO UNDERSTAND THE LIVED EXPERIENCES OF INDIVIDUALS WITH DISABILITY WHO ARE REGULAR PARTICIPANTS IN THE YOGA FOR EVERYONE CLASS TO INFORM FUTURE RESEARCH, INTERVENTION AND COMMUNITY PROGRAMS.METHODS: A PHENOMENOLOGICAL QUALITATIVE APPROACH UTILIZED SEMI-STRUCTURED INTERVIEWS AND CLASS OBSERVATIONS. DATA WAS ANALYZED THROUGH ITERATIVE INDUCTIVE THEMATIC ANALYSIS.RESULTS: SIX PEOPLE OF VARIED MOBILITY LIMITATIONS PARTICIPATED. THEMATIC ANALYSIS REVEALED THEMES ON INFLUENTIAL ENVIRONMENTAL AND PERSONAL FACTORS, A HOLISTIC-FOCUSED CLASS ENVIRONMENT, PHYSICAL IMPROVEMENTS, MENTAL/EMOTIONAL IMPACT, AND A SENSE OF BELONGING TO COMMUNITY.CONCLUSION: THE YOGA FOR EVERYONE CLASS FOSTERED MULTI-FACETED OUTCOMES FOR PEOPLE WITH DIVERSE MOVEMENT IMPAIRMENTS. FOCUSING ON COMMUNITY-CLINICAL PARTNERSHIPS, UTILIZING A CLASS STRUCTURE WITH VOLUNTEERS, AND FOSTERING AN ONGOING INCLUSIVE SOCIAL ENVIRONMENT ARE POTENTIAL STRATEGIES FOR SUCCESS IN OTHER COMMUNITY PROGRAMS FOR THOSE WITH DISABILITY. 2022 14 2843 36 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 15 1941 52 SAFETY AND EFFICACY OF AYURVEDIC INTERVENTIONS AND YOGA ON LONG TERM EFFECTS OF COVID-19: A STRUCTURED SUMMARY OF A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: PRIMARY OBJECTIVE * TO ASSESS THE EFFICACY OF AYURVEDA INTERVENTIONS AND YOGA IN REHABILITATION OF COVID-19 CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 AS COMPARED TO WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19- RELATED ILLNESS. SECONDARY OBJECTIVE * TO ASSESS THE SAFETY OF AYURVEDIC INTERVENTIONS IN CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 TRIAL DESIGN: MULTI-CENTRIC, RANDOMIZED, CONTROLLED, PARALLEL GROUP, OPEN-LABEL, EXPLORATORY STUDY. THE STUDY DURATION IS 9 MONTHS AND THE INTERVENTION PERIOD IS 90 DAYS FROM THE DAY OF ENROLMENT OF THE PARTICIPANT. PARTICIPANTS: PATIENTS OF EITHER SEX BETWEEN 18 TO 60 YEARS, AMBULATORY, WILLING TO PARTICIPATE, WITH HISTORY (NOT MORE THAN 4 WEEKS) OF POSITIVE RT-PCR FOR COVID-19 OR IGM ANTIBODIES POSITIVITY FOR SARS COV-2, BUT HAVING NEGATIVE RT-PCR FOR COVID-19 AT THE TIME OF SCREENING WILL BE CONSIDERED ELIGIBLE FOR ENROLMENT IN THE STUDY. CRITICALLY ILL PATIENTS WITH ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME), REQUIRING INVASIVE RESPIRATORY SUPPORT IN THE INTENSIVE CARE UNIT, KNOWN CASE OF ANY MALIGNANCY, IMMUNE-COMPROMISED STATE (E.G. HIV), DIABETES MELLITUS, ACTIVE PULMONARY TUBERCULOSIS, PAST HISTORY OF ANY CHRONIC RESPIRATORY DISEASE, MOTOR NEURON DISEASE, MULTIPLE SCLEROSIS, STROKE, IMPAIRED COGNITION, ATRIAL FIBRILLATION, ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, SEVERE ARRHYTHMIA, CONCURRENT SERIOUS HEPATIC DISEASE OR RENAL DISEASE, PREGNANT OR LACTATING WOMEN, PATIENTS ON IMMUNOSUPPRESSIVE MEDICATIONS, HISTORY OF HYPERSENSITIVITY TO THE TRIAL DRUGS OR THEIR INGREDIENTS, DEPRESSIVE ILLNESS (BEFORE COVID-19), DIAGNOSED PSYCHOTIC ILLNESSES, SUBSTANCE DEPENDENCE OR ALCOHOLISM WILL BE EXCLUDED. THE TRIAL WILL BE CONDUCTED AT TWO MEDICAL COLLEGES IN MAHARASHTRA, INDIA. INTERVENTION AND COMPARATOR: INTERVENTION ARM (GROUP-I): AYURVEDA INTERVENTIONS INCLUDING AGASTYA HARITAKI SIX GRAM AND ASHWAGANDHA TABLET 500 MG TWICE DAILY ORALLY AFTER MEALS WITH WARM WATER AND TWO SESSIONS OF YOGA (MORNING 30 MINUTES AND EVENING 15 MINUTES) DAILY FOR 90 DAYS, AS PER THE POST-COVID-19 CARE PROTOCOL PROVIDED IN NATIONAL CLINICAL MANAGEMENT PROTOCOL BASED ON AYURVEDA AND YOGA FOR MANAGEMENT OF COVID-19 PUBLISHED BY MINISTRY OF AYUSH, GOVERNMENT OF INDIA. COMPARATOR ARM (GROUP-II): WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19 RELATED ILLNESS FOR 90 DAYS. THE TRIAL DRUGS ARE BEING PROCURED FROM A GMP CERTIFIED PHARMACEUTICAL COMPANY. MAIN OUTCOMES: PRIMARY OUTCOME: CHANGE IN RESPIRATORY FUNCTION TO BE ASSESSED BY SAN DIEGO SHORTNESS OF BREATH QUESTIONNAIRE, 6-MINUTES WALK TEST AND PULMONARY FUNCTION TEST. SECONDARY OUTCOMES: CHANGE IN HIGH-RESOLUTION COMPUTED TOMOGRAPHY (HRCT) CHEST CHANGE IN FATIGUE SCORE ASSESSED BY MODIFIED FATIGUE IMPACT SCALE CHANGE IN ANXIETY SCORE ASSESSED BY HOSPITAL ANXIETY AND DEPRESSION SCALE SCORE CHANGE IN SLEEP QUALITY ASSESSED BY PITTSBURGH SLEEP QUALITY INDEX CHANGE IN THE QUALITY OF LIFE ASSESSED BY COV19-QOL SCALE SAFETY OF THE INTERVENTIONS WILL BE ASSESSED BY COMPARING HEMATOLOGICAL AND BIOCHEMICAL INVESTIGATIONS BEFORE AND AFTER THE INTERVENTION PERIOD AND ADVERSE EVENT/ ADVERSE DRUG REACTION TIMELINES FOR OUTCOME ASSESSMENT: SUBJECTIVE PARAMETERS AND CLINICAL ASSESSMENT WILL BE ASSESSED AT BASELINE, 15(TH) DAY, 30(TH) DAY, 60(TH) DAY AND 90(TH) DAY. LABORATORY PARAMETERS (CBC, LFT, KFT, HBA1C, HS-CRP, D-DIMER), PULMONARY FUNCTION TEST AND HRCT CHEST WILL BE DONE AT BASELINE AND AFTER COMPLETION OF STUDY PERIOD I.E. 90(TH) DAY. RANDOMISATION: STATISTICAL PACKAGE FOR SOCIAL SCIENCES (SPSS) VERSION 15.0 IS USED TO GENERATE THE RANDOM NUMBER SEQUENCES. THE PARTICIPANTS WILL BE RANDOMIZED TO TWO STUDY GROUPS IN THE RATIO OF 1:1. BLINDING (MASKING): THE STUDY IS OPEN-LABEL DESIGN. HOWEVER, THE OUTCOME ASSESSOR WILL BE KEPT BLINDED REGARDING THE STUDY GROUP ALLOCATION OF THE PARTICIPANTS. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: THE SAMPLE SIZE FOR THE STUDY IS CALCULATED ASSUMING IMPROVEMENT IN 6-MINUTES WALK TEST BY 40 METER IN GROUP I AND A CHANGE OF 10 METER IN GROUP II WITH A STANDARD DEVIATION OF 50 METER BASED ON THE RESULTS OF THE PREVIOUS STUDIES, WITH 95% CONFIDENCE LEVEL (ALPHA = 0.05) AND 80% POWER AND EXPECTING A DROPOUT RATE OF 20%. THE NUMBER OF PARTICIPANTS TO BE ENROLLED IN THE STUDY SHOULD BE APPROXIMATELY 55 IN EACH GROUP. HENCE, A TOTAL OF 110 PARTICIPANTS WILL BE ENROLLED IN THE TRIAL AT EACH STUDY SITE. TRIAL STATUS: PARTICIPANTS' RECRUITMENT STARTED ON 1(ST) MAY 2021. ANTICIPATED END OF RECRUITMENT IS AUGUST 2021. PROTOCOL NUMBER: CCRAS-01 PROTOCOL VERSION NUMBER: 1.1, 13TH JANUARY 2021. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE CLINICAL TRIAL REGISTRY OF INDIA (CTRI) ON 03(RD) MARCH 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: THE FULL PROTOCOL IS ATTACHED AS AN ADDITIONAL FILE, ACCESSIBLE FROM THE JOURNAL WEBSITE (ADDITIONAL FILE 1). THIS COMMUNICATION SERVES AS A SUMMARY OF THE KEY ELEMENTS OF THE FULL PROTOCOL. 2021 16 1224 31 FEASIBILITY AND ASSESSMENT OF OUTCOME MEASURES FOR YOGA AS SELF-CARE FOR MINORITIES WITH ARTHRITIS: A PILOT STUDY. BACKGROUND: WHILE THERE IS A GROWING INTEREST IN THE THERAPEUTIC BENEFITS OF YOGA, MINORITY POPULATIONS WITH ARTHRITIS TEND TO BE UNDER-REPRESENTED IN THE RESEARCH. ADDITIONALLY, THERE IS AN ABSENCE OF GUIDANCE IN THE LITERATURE REGARDING THE USE OF MULTICULTURAL TEAMS AND SOCIOCULTURAL HEALTH BELIEFS, WHEN DESIGNING YOGA STUDIES FOR A RACIALLY DIVERSE POPULATION WITH ARTHRITIS. THIS PILOT STUDY EXAMINED THE FEASIBILITY OF OFFERING YOGA AS A SELF-CARE MODALITY TO AN URBAN, BILINGUAL, MINORITY POPULATION WITH OSTEOARTHRITIS (OA) OR RHEUMATOID ARTHRITIS (RA), IN THE WASHINGTON, DC AREA. METHODS: THE PRIMARY OBJECTIVE OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF OFFERING AN 8-WEEK, BILINGUAL YOGA INTERVENTION ADAPTED FOR ARTHRITIS TO A CONVENIENCE SAMPLE OF PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. A RACIALLY DIVERSE INTERDISCIPLINARY RESEARCH TEAM WAS ASSEMBLED TO DESIGN A STUDY TO FACILITATE RECRUITMENT AND RETENTION. THE SECOND OBJECTIVE IDENTIFIED OUTCOME MEASURES TO OPERATIONALIZE POTENTIAL FACILITATORS AND BARRIERS TO SELF-CARE AND SELF-EFFICACY. THE THIRD OBJECTIVE DETERMINED THE FEASIBILITY OF USING COMPUTER-ASSISTED SELF-INTERVIEW (CASI) FOR DATA COLLECTION. RESULTS: ENROLLED PARTICIPANTS (N = 30) WERE MOSTLY FEMALE (93%), SPANISH SPEAKING (69%), AND DIAGNOSED WITH RA (88.5%). FEASIBILITY WAS EVALUATED USING PRACTICALITY, ACCEPTABILITY, ADAPTATION, AND EXPANSION OF AN ARTHRITIS-ADAPTED YOGA INTERVENTION, MODIFIED FOR THIS POPULATION. RECRUITMENT (51%) AND PARTICIPATION (60%) RATES WERE SIMILAR TO PREVIOUS RESEARCH AND CLINICAL EXPERIENCE WITH THE STUDY POPULATION. OF THOSE ENROLLED, 18 STARTED THE INTERVENTION. FOR ADHERENCE, 12 OUT OF 18 (67%) PARTICIPANTS COMPLETED THE INTERVENTION. ALL (100%), WHO COMPLETED THE INTERVENTION, CONTINUED TO PRACTICE YOGA 3 MONTHS AFTER COMPLETING THE STUDY. USING NONPARAMETRIC TESTS, SELECTED OUTCOME MEASURES SHOWED A MEASURABLE CHANGE POST-INTERVENTION SUGGESTING APPROPRIATE USE IN FUTURE STUDIES. AN IN-PERSON COMPUTERIZED QUESTIONNAIRE WAS DETERMINED TO BE A FEASIBLE METHOD OF DATA COLLECTION. CONCLUSIONS: FINDINGS FROM THIS PILOT STUDY CONFIRM THE FEASIBILITY OF OFFERING YOGA TO THIS RACIALLY/ETHNICALLY DIVERSE POPULATION WITH ARTHRITIS. THIS ARTICLE PROVIDES RECRUITMENT/RETENTION RATES, OUTCOME MEASURES WITH ERROR RATES, AND DATA COLLECTION RECOMMENDATIONS FOR A PREVIOUSLY UNDER-REPRESENTED POPULATION. SUGGESTIONS INCLUDE ALLOCATING RESOURCES FOR TRANSLATION AND USING A MULTICULTURAL DESIGN TO FACILITATE RECRUITMENT AND RETENTION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT01617421. 2018 17 162 40 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 18 1165 50 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 19 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 20 258 46 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