1  336 193 APPROPRIATENESS AND ACCEPTABILITY OF A TELE-YOGA INTERVENTION FOR PEOPLE WITH HEART FAILURE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE: QUALITATIVE FINDINGS FROM A CONTROLLED PILOT STUDY. BACKGROUND: HEART FAILURE (HF) AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ARE HIGHLY PREVALENT AND ASSOCIATED WITH A LARGE SYMPTOM BURDEN, THAT IS COMPOUNDED IN A DUAL HF-COPD DIAGNOSIS. YOGA HAS POTENTIAL BENEFIT FOR SYMPTOM RELIEF; HOWEVER FUNCTIONAL IMPAIRMENT HINDERS ACCESS TO USUAL YOGA CLASSES. WE DEVELOPED A TELE-YOGA INTERVENTION AND EVALUATED IT IN A CONTROLLED PILOT TRIAL. THIS PAPER REPORTS ON THE APPROPRIATENESS AND ACCEPTABILITY OF THE INTERVENTION AND THE EVALUATION DESIGN. METHODS: A CONTROLLED, NON-RANDOMISED TRIAL WAS CONDUCTED OF AN 8-WEEK TELE-YOGA INTERVENTION VERSUS AN EDUCATIONAL CONTROL (INFORMATION LEAFLETS MAILED TO PARTICIPANTS WITH ONE PHONE CALL A WEEK). BIWEEKLY ONE-HOUR TELE-YOGA CLASSES WERE IMPLEMENTED VIA MULTIPOINT VIDEOCONFERENCING THAT CONNECTED PARTICIPANTS TO LIVE CLASSES VIA AN INTERNET CONNECTION TO THEIR TELEVISIONS. SEMI-STRUCTURED QUALITATIVE INTERVIEWS WERE CONDUCTED WITH PARTICIPANTS POST STUDY EXIT TO EXPLORE REASONS FOR AND EXPERIENCES OF PARTICIPATING, INCLUDING VIEWS OF STUDY OUTCOME MEASURES AND PHYSIOLOGICAL TESTS. TRANSCRIBED INTERVIEWS WERE ANALYSED USING THEMATIC CONTENT ANALYSIS. RESULTS: FIFTEEN PEOPLE PARTICIPATED IN THE PILOT STUDY (7 IN THE INTERVENTION GROUP, 8 IN THE CONTROL). OF THESE, 12 PARTICIPANTS WERE INTERVIEWED, 6 IN EACH GROUP, MEAN AGE 71.2 YEARS (SD 10.09); 3 WERE MALE. THEMES ARE REPORTED IN THE FOLLOWING CATEGORIES: ACCEPTABILITY AND APPROPRIATENESS OF THE INTERVENTION, POTENTIAL ACTIVE INGREDIENTS OF THE INTERVENTION, ACCEPTABILITY AND APPROPRIATENESS OF THE CONTROL, PARTICIPATION IN THE RESEARCH, AND ACCEPTABILITY OF THE TESTING PROCEDURES. THE INTERVENTION WAS ACCEPTABLE AND APPROPRIATE: THE INTERVENTION GROUP REPORTED ENJOYING YOGA AND VALUING THE HOME-BASED ASPECT AND PARTICIPANTS DESCRIBED A HIGH SYMPTOM BURDEN AND SOCIAL ISOLATION. HOWEVER, TECHNOLOGICAL PROBLEMS RESULTED IN POOR VIDEO-STREAMING QUALITY FOR SOME PARTICIPANTS. POTENTIAL ACTIVE INGREDIENTS INCLUDED PHYSICAL POSTURES, BREATHING EXERCISES AND GUIDANCE IN RELAXATION AND MEDITATION. THE EDUCATIONAL CONTROL INTERVENTION WAS ACCEPTABLE AND APPROPRIATE, WITH PARTICIPANTS REPORTING LITTLE EFFECT ON THEIR WELL-BEING AND NO IMPACT ON MECHANISMS HYPOTHESISED TO EXPLAIN YOGA'S EFFECTIVENESS. THE QUESTIONNAIRES AND HOME PHYSIOLOGICAL TESTING WERE ACCEPTABLE TO PARTICIPANTS. CONCLUSIONS: TELE-YOGA IS AN ACCEPTABLE AND APPROPRIATE INTERVENTION IN PEOPLE WITH HF AND COPD AND FURTHER RESEARCH IS WARRANTED TO REFINE THE TECHNOLOGY USED IN ITS DELIVERY. FINDINGS PROVIDE GUIDANCE FOR RESEARCHERS WORKING IN TELE-INTERVENTIONS, YOGA, AND SIMILAR POPULATIONS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT02078739 (4 MARCH 2014).	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
2 1181  70 EVALUATION OF THE FEASIBILITY OF A HOME-BASED TELEYOGA INTERVENTION IN PARTICIPANTS WITH BOTH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND HEART FAILURE. OBJECTIVE: TEST THE FEASIBILITY AND CLINICAL OUTCOMES OF A HOME-BASED VIDEOCONFERENCING YOGA INTERVENTION IN PARTICIPANTS DIAGNOSED WITH BOTH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND HEART FAILURE (HF). BACKGROUND: YOGA HAS POTENTIAL BENEFIT FOR SYMPTOM RELIEF IN PARTICIPANTS WITH COPD AND WITH HF; HOWEVER, FUNCTIONAL IMPAIRMENT AND TRANSPORTATION ISSUES CAN HINDER ACCESS TO TYPICAL YOGA CLASSES. METHODS: A CONTROLLED, NONRANDOMIZED TRIAL WAS CONDUCTED OF AN 8-WEEK TELEYOGA INTERVENTION VERSUS AN EDUCATIONAL CONTROL (INFORMATION LEAFLETS MAILED TO PARTICIPANTS WITH ONE WEEKLY PHONE CALL). ONE-HOUR TELEYOGA CLASSES WERE IMPLEMENTED TWICE WEEKLY VIA MULTIPOINT VIDEOCONFERENCING, WHICH CONNECTED PARTICIPANTS TO LIVE CLASSES VIA AN INTERNET CONNECTION TO THEIR TELEVISIONS. RESULTS: FOURTEEN PARTICIPANTS WITH COPD AND HF TOOK PART IN THE PILOT STUDY (7 IN THE INTERVENTION GROUP AND 8 IN THE CONTROL). INTERVENTION PARTICIPANTS WERE ADHERENT TO CLASSES, ABLE TO SAFELY PARTICIPATE, AND FOUND THE CLASSES ENJOYABLE AFTER THE 8-WEEK PROGRAM. DYSPNEA AFTER EXERCISE IMPROVED IN THE INTERVENTION GROUP. CONCLUSIONS: DESPITE THEIR FRAILTY, PATIENTS DIAGNOSED WITH BOTH COPD AND HF WERE ABLE TO PERFORM YOGA SAFELY IN THE HOME SETTING. TELEYOGA WAS ACCEPTABLE AND ADHERENCE WAS GOOD; HOWEVER, TECHNICAL ISSUES WERE AN IMPORTANT HINDRANCE TO PARTICIPATION.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
3  631  36 DIFFERENCES IN SKELETAL GROWTH PATTERN OF YOGA PRACTISING ADOLESCENT GIRLS: A CROSS-SECTIONAL STUDY. BACKGROUND: YOGASANA IMPROVES BOTH MENTAL AND PHYSICAL HEALTH. THERE IS SPARSE SYSTEMATIC RESEARCH ON THE GROWTH OF YOGASANA PRACTISING ADOLESCENTS. OBJECTIVES: THIS STUDY AIMS TO ASSESS THE DIFFERENTIAL SKELETAL GROWTH PATTERN AMONG PRE-ADOLESCENT AND ADOLESCENT GIRLS AS A RESULT OF YOGA PRACTICE. METHODS: A CROSS-SECTIONAL ANTHROPOMETRIC STUDY WAS CONDUCTED ON STATURE (HEIGHT), SITTING HEIGHT AND LEG LENGTH OF 757 SCHOOL-GOING GIRLS (4-15 YEARS OLD), DIVIDED IN TWO GROUPS, YOGA GROUP (YG) (N=380) AND AGE MATCHED CONTROL GROUP (CG) (N=377) PARTICIPANTS PARTICIPATING IN RECREATIONAL GAMES OTHER THAN YOGA. DESCRIPTIVE AND INFERENTIAL STATISTICAL ANALYSES WERE APPLIED. UNPAIRED T-TEST WAS PERFORMED FOR ASSESSMENT OF LEVEL OF SIGNIFICANCE AND PEARSON'S CORRELATION (R) TEST WAS PERFORMED TO TO IDENTIFY THE ASSOCIATION BETWEEN GROWTH PATTERN OF STATURE AND LEG LENGTH AT SPECIFIC AGES. RESULTS: THE PHYSICAL GROWTH SHOWED AN ASCENDING TREND IN BOTH YOGA GROUP (YG)(2) PARTICIPANTS AND CONTROL GROUP (CG)(3) . AT THE ONSET OF ADOLESCENCE (10-12 YEARS) THE MEAN STATURE AND LEG LENGTH OF YG PARTICIPANTS WERE RETARDED (P < 0.05). SITTING HEIGHT IN YG WAS SIGNIFICANTLY (P < 0.05) LOW ONLY IN 10-YEAR-OLDS. THE SIMILAR TRENDS WERE OBSERVED IN STATURE AND LEG LENGTH IN YG PARTICIPANTS AT 10 YEARS (5TH AND 10TH PERCENTILE) AND 12 YEARS (90TH AND 95TH PERCENTILE). THERE WAS STRONG POSITIVE RELATIONSHIP BETWEEN STATURE AND LEG LENGTH OF YG PARTICIPANTS (10 YEARS, R = 0.86, P < 0.01; 11 YEARS, R = 0.86, P < 0.01; 12 YEARS, R = 0.72, P < 0.01). THE STUNTED GROWTH IN YG PARTICIPANTS DURING ADOLESCENCE MAY BE RELATED TO RETARDED GROWTH OF LEG LENGTH. CONCLUSIONS: INTENSE YOGASANA PRACTICE WITH GREATER SKELETAL STRESS POSSIBLY HINDERS STATURE IN ADOLESCENT GIRLS FROM 10 TO 12 YEARS. THIS MAY COMPROMISE WITH THE NATURAL GROWTH PATTERN, NECESSITATING SPECIAL CARE DURING YOGA TRAINING AMONG ADOLESCENTS WHILE SELECTING THE TYPE, INTENSITY AND DURATION OF YOGASANAS PRACTICE.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
4  144  49 A QUALITATIVE APPROACH EXPLORING THE ACCEPTABILITY OF YOGA FOR MINORITIES LIVING WITH ARTHRITIS: 'WHERE ARE THE PEOPLE WHO LOOK LIKE ME?' OBJECTIVES: TO EXAMINE THE ACCEPTABILITY OF YOGA RESEARCH TAILORED TO RECRUIT AND RETAIN A MINORITY POPULATION (BOTH ENGLISH AND SPANISH SPEAKING) WITH ARTHRITIS. YOGA RESEARCH FOR ARTHRITIS OFTEN UNDERREPRESENTS MINORITIES AND ACCEPTABILITY FOR THIS POPULATION HAS NOT PREVIOUSLY BEEN INVESTIGATED. DESIGN: ACCEPTABILITY WAS EVALUATED USING RETENTION, ADHERENCE, JOURNALS, AND SEMI-STRUCTURED EXIT INTERVIEWS FROM TWELVE PARTICIPANTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS UNDERGOING AN 8-WEEK YOGA INTERVENTION. JOURNAL QUOTES WERE ANALYZED USING CONTENT ANALYSIS TECHNIQUES. NVIVO SOFTWARE WAS USED TO ORGANIZE TRANSCRIPTS AND ASSEMBLE THEMES. TWO METHODS OF TRIANGULATION (DATA AND INVESTIGATOR) WERE USED TO OVERCOME POTENTIAL BIAS FROM A SINGLE-PERSPECTIVE INTERPRETATION. EXIT INTERVIEW COMMENTS WERE CONTENT ANALYZED USING A CARD SORT METHOD. THE STUDY WAS DESIGNED WITH A CULTURAL INFRASTRUCTURE INCLUDING A MULTICULTURAL RESEARCH TEAM, TRANSLATORS, AND BILINGUAL MATERIALS AND CLASSES, TO FACILITATE TRUST AND ACCEPTABILITY FOR PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. SETTING: WASHINGTON, D.C. METROPOLITAN AREA, USA. RESULTS: ON AVERAGE PARTICIPANTS ATTENDED 10 OF 16 CLASSES, WITH HOME PRACTICE 2-3DAYS A WEEK. ALL WHO COMPLETED WERE STILL PRACTICING YOGA THREE-MONTHS LATER. QUALITATIVE NARRATIVE ANALYSIS IDENTIFIED MAJOR THEMES RELATED TO FACILITATING FACTORS AND BARRIERS FOR YOGA PRACTICE, SELF-EFFICACY, AND SUPPORT. PARTICIPANT COMMENTS INDICATED THAT OFFERING AN ARTHRITIS-BASED YOGA INTERVENTION AND USING A CULTURALLY CONGRUENT RESEARCH DESIGN WAS FOUND TO BE ACCEPTABLE. CONCLUSIONS: AS YOGA RESEARCH GROWS, THERE IS A NEED TO UNDERSTAND AND PROMOTE ACCEPTABILITY FOR TYPICALLY UNDER-REPRESENTED POPULATIONS. THIS STUDY ATTEMPTS TO INFORM THE EXPANSION OF MULTICULTURAL RESEARCH DESIGNED TO RECRUIT AND RETAIN THOSE FROM DIVERSE BACKGROUNDS.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
5 2389  56 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                      
6 2763  45 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
7 2360  40 VIDEOCONFERENCED YOGA INTERVENTIONS FOR CANCER PATIENTS AND THEIR CAREGIVERS DURING THE COVID-19 PANDEMIC: A REPORT FROM A CLINICIAN'S PERSPECTIVE. BACKGROUND: THE ACCEPTABILITY OF VIDEOCONFERENCING DELIVERY OF YOGA INTERVENTIONS IN THE ADVANCED CANCER SETTING IS RELATIVELY UNEXPLORED. THE CURRENT REPORT SUMMARIZES THE CHALLENGES AND SOLUTIONS OF THE TRANSITION FROM AN IN-PERSON (IE, FACE-TO-FACE) TO A VIDEOCONFERENCE INTERVENTION DELIVERY APPROACH IN RESPONSE TO THE CORONAVIRUS DISEASE PANDEMIC. METHOD: PARTICIPANTS INCLUDED PATIENT-FAMILY CAREGIVER DYADS WHO WERE ENROLLED IN ONGOING YOGA TRIALS AND 2 CERTIFIED YOGA THERAPISTS WHO DELIVERED THE YOGA SESSIONS. WE SUMMARIZED THEIR EXPERIENCES USING RECORDINGS OF THE YOGA SESSIONS AND INTERVENTIONISTS' PROGRESS NOTES. RESULTS: OUT OF 7 DYADS PARTICIPATING IN THE PARENT TRIAL, 1 DECLINED THE VIDEOCONFERENCED SESSIONS. PARTICIPANTS WERE BETWEEN THE AGES OF 55 AND 76 AND MOSTLY NON-HISPANIC WHITE (83%). PATIENTS WERE MAINLY MALE (83%), ALL HAD STAGE III OR IV CANCER AND WERE UNDERGOING RADIOTHERAPY. CAREGIVERS WERE ALL FEMALE. DESPITE CHALLENGES IN THE AREAS OF TECHNOLOGY, LOCATION, AND SETTING, INSTRUCTION AND PERSONAL CONNECTION, THE OVERALL ACCEPTABILITY WAS HIGH AMONG PATIENTS, CAREGIVERS, AND INSTRUCTORS. THROUGH THIS TRANSITION PROCESS, SOLUTIONS TO THESE CHALLENGES WERE FOUND, WHICH ARE DESCRIBED HERE. CONCLUSION: ALTHOUGH IN-PERSON INTERVENTIONS ARE FAVORED BY BOTH THE STUDY PARTICIPANTS AND THE INTERVENTIONISTS, VIDEOCONFERENCE SESSIONS WERE DEEMED ACCEPTABLE. ALL PARTICIPANTS HAD THE BENEFIT OF A PREVIOUS IN-PERSON EXPERIENCE, WHICH WAS HELPFUL AND PERHAPS NECESSARY FOR OLDER AND ADVANCED CANCER PATIENTS REQUIRING PRACTICE MODIFICATIONS. IN A REMOTE SETTING, THE ASSISTANCE OF CAREGIVERS SEEMS PARTICULARLY BENEFICIAL TO ENSURE PRACTICE SAFETY. CLINICALTRIALS.GOV: NCT03948100; NCT02481349.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
8 2831  42 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
9 1224  47 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
10  518  40 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
11  619  41 DEVELOPMENT OF THE CLARIFY (CHECKLIST STANDARDISING THE REPORTING OF INTERVENTIONS FOR YOGA) GUIDELINES: A DELPHI STUDY. BACKGROUND: THE USE OF YOGA AS A THERAPEUTIC MODALITY IS INCREASING; HOWEVER, A LACK OF TRANSPARENT INTERVENTION REPORTING IS RESTRICTING THE DISSEMINATION AND IMPLEMENTATION OF YOGA RESEARCH INTO CLINICAL AND COMMUNITY PRACTICE. THE AIM OF THIS STUDY WAS TO DEVELOP A YOGA-SPECIFIC REPORTING GUIDELINE AS AN EXTENSION TO EXISTING REPORTING GUIDELINES FOR RANDOMISED CONTROLLED TRIALS, OBSERVATIONAL STUDIES AND CASE REPORTS. METHODS: RECOGNISED INTERNATIONAL STAKEHOLDERS IN THE DESIGN AND CONDUCT OF YOGA RESEARCH WERE INVITED TO CONTRIBUTE TO THE ELECTRONIC DELPHI SURVEY. A FOUR-ROUND DELPHI WAS CONDUCTED, WHEREBY PANELLISTS RATED SELECTED ITEMS FOR THEIR IMPORTANCE IN THE INCLUSION OF YOGA REPORTING GUIDELINES, ACCORDING TO A 5-STEP LIKERT SCALE. A PRIORI CONSENSUS FOR ITEM INCLUSION WAS AGREEMENT OF ITEMS AS 'VERY IMPORTANT' OR 'EXTREMELY IMPORTANT' BY >/=80% OF PANELLISTS. NON-CONSENSUS ITEMS WERE FORWARDED TO SUBSEQUENT ROUNDS FOR RE-RATING. RESULTS: 53 EXPERTS IN YOGA RESEARCH FROM 11 COUNTRIES, PRIMARILY IDENTIFYING AS RESEARCHERS (50%), ALLIED HEALTH PROFESSIONALS (18.8%) AND YOGA PROFESSIONALS (12.5%), CONSENTED TO PARTICIPATE IN THE DELPHI. OF THESE, 48 COMPLETED ROUND 1 (91%), 43 COMPLETED ROUND 2 (81%), 39 COMPLETED ROUND 3 (74%) AND 32 COMPLETED ROUND 4 (60%). PANELLISTS REACHED CONSENSUS FOR INCLUSION ON 21 ITEMS, GROUPED UNDER 10 DOMAINS REFLECTIVE OF MORE GENERIC INTERVENTION-BASED GUIDELINES. CONCLUSIONS: THE CONSENSUS-BASED 21-ITEM CLARIFY (CHECKLIST STANDARDISING THE REPORTING OF INTERVENTIONS FOR YOGA) CHECKLIST PROVIDES A MINIMUM REPORTING TEMPLATE FOR RESEARCHERS ACROSS A RANGE OF METHODOLOGY DESIGNS. USE OF THESE YOGA-SPECIFIC GUIDELINES, IN CONJUNCTION WITH THE CLARIFY EXPLANATION AND ELABORATION GUIDELINES, WILL STANDARDISE THE MINIMUM LEVEL OF DETAIL REQUIRED FOR TRANSPARENT YOGA INTERVENTION, FACILITATING THE REPLICATION, DISSEMINATION AND IMPLEMENTATION OF YOGA RESEARCH. ONGOING RESEARCH WILL ASSESS THE UPTAKE AND IMPACT OF CLARIFY, TO ENSURE THESE GUIDELINES RETAIN THEIR RELEVANCE TO THE INTERNATIONALLY GROWING FIELD OF YOGA RESEARCH.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
12   20  44 "WE'RE ALL IN THIS TOGETHER": A QUALITATIVE STUDY OF PREDOMINANTLY LOW INCOME MINORITY PARTICIPANTS IN A YOGA TRIAL FOR CHRONIC LOW BACK PAIN. OBJECTIVE: TO EXPLORE THE EXPERIENCES OF LOW-INCOME MINORITY ADULTS TAKING PART IN A YOGA DOSING TRIAL FOR CHRONIC LOW BACK PAIN. DESIGN: INDIVIDUAL SEMI-STRUCTURED INTERVIEWS WERE CONDUCTED WITH NINETEEN PARTICIPANTS RECRUITED FROM A RANDOMIZED YOGA DOSING TRIAL FOR PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN. INTERVIEWS DISCUSSED THE IMPACT OF YOGA ON LOW BACK PAIN AND EMOTIONS; OTHER PERCEIVED ADVANTAGES OR DISADVANTAGES OF THE INTERVENTION; AND FACILITATORS AND BARRIERS TO PRACTICING YOGA. INTERVIEWS WERE AUDIO TAPED AND TRANSCRIBED, CODED USING ATLAS.TI SOFTWARE, AND ANALYZED WITH INDUCTIVE AND DEDUCTIVE THEMATIC ANALYSIS METHODS. SETTING: BOSTON MEDICAL CENTER, BOSTON, MA, USA. RESULTS: PARTICIPANTS VIEWED YOGA AS A MEANS OF PAIN RELIEF AND ATTRIBUTED IMPROVED MOOD, GREATER ABILITY TO MANAGE STRESS, AND ENHANCED RELAXATION TO YOGA. OVERALL, PARTICIPANTS FELT EMPOWERED TO SELF-MANAGE THEIR PAIN. SOME FOUND YOGA TO BE HELPFUL IN BEING MINDFUL OF THEIR EMOTIONS AND ACCEPTING OF THEIR PAIN. TRUST IN THE YOGA INSTRUCTORS WAS A COMMONLY CITED FACILITATOR FOR YOGA CLASS ATTENDANCE. LACK OF TIME, MOTIVATION, AND FEAR OF INJURY WERE REPORTED BARRIERS TO YOGA PRACTICE. CONCLUSIONS: YOGA IS A MULTIDIMENSIONAL TREATMENT FOR LOW BACK PAIN THAT HAS THE POTENTIAL TO FAVORABLY IMPACT HEALTH IN A PREDOMINANTLY LOW-INCOME MINORITY POPULATION.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
13 2596  51 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
14 1699  54 PARTICIPANT CHARACTERISTICS ASSOCIATED WITH SYMPTOMATIC IMPROVEMENT FROM YOGA FOR CHRONIC LOW BACK PAIN. CONTEXT: STUDIES SUGGEST THAT YOGA IS EFFECTIVE FOR MODERATE TO SEVERE CHRONIC LOW BACK PAIN (CLBP) IN DIVERSE PREDOMINANTLY LOWER SOCIOECONOMIC STATUS POPULATIONS. HOWEVER, LITTLE IS KNOWN ABOUT FACTORS ASSOCIATED WITH BENEFIT FROM THE YOGA INTERVENTION. OBJECTIVE: IDENTIFY FACTORS AT BASELINE INDEPENDENTLY ASSOCIATED WITH GREATER EFFICACY AMONG PARTICIPANTS IN A STUDY OF YOGA FOR CLBP. DESIGN: FROM SEPTEMBER-DECEMBER 2011, A 12-WEEK RANDOMIZED DOSING TRIAL WAS CONDUCTED COMPARING WEEKLY VS. TWICE-WEEKLY 75-MINUTE HATHA YOGA CLASSES FOR 95 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH NONSPECIFIC CLBP. PARTICIPANT CHARACTERISTICS COLLECTED AT BASELINE WERE USED TO DETERMINE FACTORS BEYOND TREATMENT ASSIGNMENT (REPORTED IN THE INITIAL STUDY) THAT PREDICTED OUTCOME. WE USED BIVARIATE TESTING TO IDENTIFY BASELINE CHARACTERISTICS ASSOCIATED WITH IMPROVEMENT IN FUNCTION AND PAIN, AND INCLUDED SELECT FACTORS IN A MULTIVARIATE LINEAR REGRESSION. SETTING: RECRUITMENT AND CLASSES OCCURRED IN AN ACADEMIC SAFETY-NET HOSPITAL AND FIVE AFFILIATED COMMUNITY HEALTH CENTERS IN BOSTON, MASSACHUSETTS. PARTICIPANTS: NINETY-FIVE ADULTS WITH NONSPECIFIC CLBP, AGES RANGING FROM 20-64 (MEAN 48) YEARS; 72 WOMEN AND 23 MEN. OUTCOME MEASURES: PRIMARY OUTCOMES WERE CHANGES IN BACK-RELATED FUNCTION (MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE, RMDQ; 0-23) AND MEAN LOW BACK PAIN INTENSITY (0-10) IN THE PREVIOUS WEEK, FROM BASELINE TO WEEK 12. RESULTS: ADJUSTING FOR GROUP ASSIGNMENT, BASELINE RMDQ, AGE, AND GENDER, FOREIGN NATIONALITY AND LOWER BASELINE SF36 PHYSICAL COMPONENT SCORE (PCS) WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN RMDQ. GREATER THAN HIGH SCHOOL EDUCATION LEVEL, CLBP LESS THAN 1 YEAR, AND LOWER BASELINE SF36 PCS WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN PAIN INTENSITY. OTHER DEMOGRAPHICS INCLUDING RACE, INCOME, GENDER, BMI, AND USE OF PAIN MEDICATIONS WERE NOT ASSOCIATED WITH EITHER OUTCOME. CONCLUSIONS: POOR PHYSICAL HEALTH AT BASELINE IS ASSOCIATED WITH GREATER IMPROVEMENT FROM YOGA IN BACK-RELATED FUNCTION AND PAIN. RACE, INCOME, AND BODY MASS INDEX DO NOT AFFECT THE POTENTIAL FOR A PERSON WITH LOW BACK PAIN TO EXPERIENCE BENEFIT FROM YOGA.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
15 1787  40 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
16 2829  55 YOGA VERSUS STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT SPIRITUAL PRACTICE THAT ORIGINATED IN INDIA AND IS CURRENTLY ACCEPTED IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA TO DETERMINE ITS EFFICACY AS AN ADJUNCT TO STANDARD-CARE TREATMENT. OBJECTIVES: TO EXAMINE THE EFFECTS OF YOGA VERSUS STANDARD CARE FOR PEOPLE WITH SCHIZOPHRENIA. SEARCH METHODS: WE SEARCHED THE COCHRANE SCHIZOPHRENIA GROUP TRIALS REGISTER (NOVEMBER 2012 AND JANUARY 29, 2015), WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSIS, AMED, PSYCINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE WERE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA COMPARING YOGA TO STANDARD-CARE CONTROL. DATA COLLECTION AND ANALYSIS: THE REVIEW TEAM INDEPENDENTLY SELECTED STUDIES, QUALITY RATED THESE, AND EXTRACTED DATA. FOR BINARY OUTCOMES, WE CALCULATED RISK RATIO (RR) AND ITS 95% CONFIDENCE INTERVAL (CI), ON AN INTENTION-TO-TREAT BASIS. FOR CONTINUOUS DATA, WE ESTIMATED THE MEAN DIFFERENCE (MD) BETWEEN GROUPS AND ITS 95% CI. WE EMPLOYED MIXED-EFFECT AND FIXED-EFFECT MODELS FOR ANALYSES. WE EXAMINED DATA FOR HETEROGENEITY (I(2) TECHNIQUE), ASSESSED RISK OF BIAS FOR INCLUDED STUDIES, AND CREATED 'SUMMARY OF FINDINGS' TABLES USING GRADE (GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT AND EVALUATION). MAIN RESULTS: WE INCLUDED EIGHT STUDIES IN THE REVIEW. ALL OUTCOMES WERE SHORT TERM (LESS THAN SIX MONTHS). THERE WERE CLEAR DIFFERENCES IN A NUMBER OF OUTCOMES IN FAVOUR OF THE YOGA GROUP, ALTHOUGH THESE WERE BASED ON ONE STUDY EACH, WITH THE EXCEPTION OF LEAVING THE STUDY EARLY. THESE INCLUDED MENTAL STATE (IMPROVEMENT IN POSITIVE AND NEGATIVE SYNDROME SCALE, 1 RCT, N = 83, RR 0.70 CI 0.55 TO 0.88, MEDIUM-QUALITY EVIDENCE), SOCIAL FUNCTIONING (IMPROVEMENT IN SOCIAL OCCUPATIONAL FUNCTIONING SCALE, 1 RCT, N = 83, RR 0.88 CI 0.77 TO 1, MEDIUM-QUALITY EVIDENCE), QUALITY OF LIFE (AVERAGE CHANGE 36-ITEM SHORT FORM SURVEY (SF-36) QUALITY-OF-LIFE SUBSCALE, 1 RCT, N = 60, MD 15.50, 95% CI 4.27 TO 26.73, LOW-QUALITY EVIDENCE), AND LEAVING THE STUDY EARLY (8 RCTS, N = 457, RR 0.91 CI 0.6 TO 1.37, MEDIUM-QUALITY EVIDENCE). FOR THE OUTCOME OF PHYSICAL HEALTH, THERE WAS NOT A CLEAR DIFFERENCE BETWEEN GROUPS (AVERAGE CHANGE SF-36 PHYSICAL-HEALTH SUBSCALE, 1 RCT, N = 60, MD 6.60, 95% CI -2.44 TO 15.64, LOW-QUALITY EVIDENCE). ONLY ONE STUDY REPORTED ADVERSE EFFECTS, FINDING NO INCIDENCE OF ADVERSE EVENTS IN EITHER TREATMENT GROUP. THIS REVIEW WAS SUBJECT TO A CONSIDERABLE NUMBER OF MISSING OUTCOMES, WHICH INCLUDED GLOBAL STATE, CHANGE IN COGNITION, COSTS OF CARE, EFFECT ON STANDARD CARE, SERVICE INTERVENTION, DISABILITY, AND ACTIVITIES OF DAILY LIVING. AUTHORS' CONCLUSIONS: EVEN THOUGH WE FOUND SOME POSITIVE EVIDENCE IN FAVOUR OF YOGA OVER STANDARD-CARE CONTROL, THIS SHOULD BE INTERPRETED CAUTIOUSLY IN VIEW OF OUTCOMES LARGELY BASED EACH ON ONE STUDY WITH LIMITED SAMPLE SIZES AND SHORT-TERM FOLLOW-UP. OVERALL, MANY OUTCOMES WERE NOT REPORTED AND EVIDENCE PRESENTED IN THIS REVIEW IS OF LOW TO MODERATE QUALITY - -TOO WEAK TO INDICATE THAT YOGA IS SUPERIOR TO STANDARD-CARE CONTROL FOR THE MANAGEMENT OF SCHIZOPHRENIA.	2015	
                                                                                                                                                               
17  501  58 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
18 2036  53 TELE-YOGA IN LONG TERM ILLNESS-PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL INCLUDING A PROCESS EVALUATION AND RESULTS FROM A PILOT STUDY. BACKGROUND: FOR PEOPLE WITH LONG-TERM ILLNESS, DEBILITATED BY SEVERE SYMPTOMS, IT CAN BE DIFFICULT TO ATTEND REGULAR YOGA CLASSES. WE HAVE THEREFORE DEVELOPED A TELE-HEALTH FORMAT OF YOGA THAT CAN BE DELIVERED IN THE HOME. THE TELE-YOGA WAS CO-DESIGNED WITH MEMBERS OF A PATIENT-ORGANISATION, YOGA-INSTRUCTOR, AND IT-TECHNICIAN. IT INCLUDES LIVE-STREAMED GROUP-YOGA SESSIONS TWICE A WEEK AND AN APP WITH INSTRUCTIONS ON HOW TO SELF-PERFORM YOGA. AIM: TO DESCRIBE A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (RCT) INCLUDING A PROCESS EVALUATION AND REPORT ON A PILOT STUDY EVALUATING METHOD- AND INTERVENTION-RELATED COMPONENTS INCLUDING FEASIBILITY, SAFETY, AND EFFICACY. METHODS: TEN PARTICIPANTS WITH HEART FAILURE AGED BETWEEN 41-76 YEARS WERE RANDOMISED TO TELE-YOGA (N = 5) OR TO THE CONTROL GROUP (N = 5). IN THE PILOT STUDY RECRUITMENT, ENROLMENT, RANDOMISATION, AND DATA COLLECTION OF ALL OUTCOMES INCLUDING PRIMARY, SECONDARY AND PROCESS EVALUATION MEASURES WERE TESTED ACCORDING TO THE STUDY PROTOCOL. FIDELITY, ADHERENCE AND ACCEPTABILITY TO THE TELE-YOGA GROUP TRAINING AND APP USE WAS DETERMINED. SAFETY WAS ASSESSED BY ADVERSE EVENTS. RESULTS: THE PILOT REVEALED THAT THE METHODOLOGICAL ASPECT OF THE PROTOCOL WORKED SUFFICIENTLY IN ALL ASPECTS EXCEPT FOR MISSING DATA IN THE PHYSICAL TEST OF TWO PARTICIPANTS AND ONE PARTICIPANT IN THE CONTROL-GROUP THAT DROPPED OUT OF THE STUDY AT THREE MONTHS FOLLOW-UP. THE TELE-YOGA TRAINING DID NOT LEAD TO ANY ADVERSE EVENTS OR INJURIES, ADHERENCE OF TELE-YOGA WAS SUFFICIENT ACCORDING TO PRESET LIMITS. THE TELE-YOGA INTERVENTION ALSO SHOWED SOME FAVOURABLE TRENDS OF IMPROVEMENTS IN THE COMPOSITE-END POINT COMPARED TO THE ACTIVE CONTROL GROUP. HOWEVER, SINCE DATA ONLY WAS PRESENTED DESCRIPTIVELY DUE TO THE SMALL SAMPLE SIZE, THE IMPACT OF THESE TRENDS SHOULD BE INTERPRETED CAREFULLY. CONCLUSION: OUR PILOT STUDY SHOWED PROMISING RESULTS IN FEASIBILITY, SAFETY, AND ACCEPTABILITY OF THE TELE-YOGA INTERVENTION. SOME CHANGES IN THE PROTOCOL HAVE BEEN MADE TO DECREASE THE RISK OF MISSING DATA IN THE MEASURES OF PHYSICAL FUNCTION AND IN THE FULL-SCALE RCT NOW ONGOING THE RESULTS OF THE SAMPLE SIZE CALCULATION FOR 300 PARTICIPANTS HAVE INCLUDED THE ESTIMATED LEVEL OF DROP OUTS AND MISSING DATA.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
19 2827  58 YOGA VERSUS NON-STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT SPIRITUAL PRACTICE THAT ORIGINATED IN INDIA AND IS CURRENTLY ACCEPTED IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA AS AN ALTERNATIVE OR ADJUNCTIVE TREATMENT. OBJECTIVES: TO SYSTEMATICALLY ASSESS THE EFFECTS OF YOGA VERSUS NON-STANDARD CARE FOR PEOPLE WITH SCHIZOPHRENIA. SEARCH METHODS: THE INFORMATION SPECIALIST OF THE COCHRANE SCHIZOPHRENIA GROUP SEARCHED THEIR SPECIALISED TRIALS REGISTER (LATEST 30 MARCH 2017), WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSIS, AMED, PSYCINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE ARE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA AND COMPARING YOGA WITH NON-STANDARD CARE. WE INCLUDED TRIALS THAT MET OUR SELECTION CRITERIA AND REPORTED USEABLE DATA. DATA COLLECTION AND ANALYSIS: THE REVIEW TEAM INDEPENDENTLY SELECTED STUDIES, ASSESSED QUALITY, AND EXTRACTED DATA. FOR BINARY OUTCOMES, WE CALCULATED RISK RATIO (RR) AND ITS 95% CONFIDENCE INTERVAL (CI), ON AN INTENTION-TO-TREAT BASIS. FOR CONTINUOUS DATA, WE ESTIMATED THE MEAN DIFFERENCE (MD) BETWEEN GROUPS AND ITS 95% CI. WE EMPLOYED A FIXED-EFFECT MODELS FOR ANALYSES. WE EXAMINED DATA FOR HETEROGENEITY (I(2) TECHNIQUE), ASSESSED RISK OF BIAS FOR INCLUDED STUDIES, AND CREATED A 'SUMMARY OF FINDINGS' TABLE FOR SEVEN MAIN OUTCOMES OF INTEREST USING GRADE (GRADING OF RECOMMENDATIONS ASSESSMENT, DEVELOPMENT AND EVALUATION). MAIN RESULTS: WE WERE ABLE TO INCLUDE SIX STUDIES (586 PARTICIPANTS). NON-STANDARD CARE CONSISTED SOLELY OF ANOTHER TYPE OF EXERCISE PROGRAMME. ALL OUTCOMES WERE SHORT TERM (LESS THAN SIX MONTHS). THERE WAS A CLEAR DIFFERENCE IN THE OUTCOME LEAVING THE STUDY EARLY (6 RCTS, N=586, RR 0.64 CI 0.49 TO 0.83, MEDIUM QUALITY EVIDENCE) IN FAVOUR OF THE YOGA GROUP. THERE WERE NO CLEAR DIFFERENCES BETWEEN GROUPS FOR THE REMAINING OUTCOMES. THESE INCLUDED MENTAL STATE (IMPROVEMENT IN POSITIVE AND NEGATIVE SYNDROME SCALE, 1 RCT, N=84, RR 0.81 CI 0.62 TO 1.07, LOW QUALITY EVIDENCE), SOCIAL FUNCTIONING (IMPROVEMENT IN SOCIAL OCCUPATIONAL FUNCTIONING SCALE, 1 RCT, N=84, RR 0.90 CI 0.78 TO 1.04, LOW QUALITY EVIDENCE), QUALITY OF LIFE (MENTAL HEALTH) (AVERAGE CHANGE 36-ITEM SHORT FORM SURVEY (SF-36) QUALITY-OF-LIFE SUB-SCALE, 1 RCT, N=69, MD -5.30 CI -17.78 TO 7.18, LOW QUALITY EVIDENCE), PHYSICAL HEALTH, (AVERAGE CHANGE WHOQOL-BREF PHYSICAL-HEALTH SUB-SCALE, 1 RCT, N=69, MD 9.22 CI -0.42 TO 18.86, LOW QUALITY EVIDENCE). ONLY ONE STUDY REPORTED ADVERSE EFFECTS, FINDING NO INCIDENCE OF ADVERSE EVENTS IN EITHER TREATMENT GROUP. THERE WERE A CONSIDERABLE NUMBER OF MISSING OUTCOMES, WHICH INCLUDED RELAPSE, CHANGE IN COGNITION, COSTS OF CARE, EFFECT ON STANDARD CARE, SERVICE INTERVENTION, DISABILITY, AND ACTIVITIES OF DAILY LIVING. AUTHORS' CONCLUSIONS: WE FOUND MINIMAL DIFFERENCES BETWEEN YOGA AND NON-STANDARD CARE, THE LATTER CONSISTING OF ANOTHER EXERCISE COMPARATOR, WHICH COULD BE BROADLY CONSIDERED AEROBIC EXERCISE. OUTCOMES WERE LARGELY BASED ON SINGLE STUDIES WITH LIMITED SAMPLE SIZES AND SHORT-TERM FOLLOW-UP. OVERALL, MANY OUTCOMES WERE NOT REPORTED AND EVIDENCE PRESENTED IN THIS REVIEW IS OF LOW TO MODERATE QUALITY - TOO WEAK TO INDICATE THAT YOGA IS SUPERIOR OR INFERIOR TO NON-STANDARD CARE CONTROL FOR MANAGEMENT OF PEOPLE WITH SCHIZOPHRENIA.	2017	

20  319  56 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