1 2857 175 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
2  900  70 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
3  614  50 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
4 2831  36 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
5 1460  40 INFLUENCE OF YOGA ON CANCER-RELATED FATIGUE AND ON MEDIATIONAL RELATIONSHIPS BETWEEN CHANGES IN SLEEP AND CANCER-RELATED FATIGUE: A NATIONWIDE, MULTICENTER RANDOMIZED CONTROLLED TRIAL OF YOGA IN CANCER SURVIVORS. BACKGROUND: CANCER-RELATED FATIGUE (CRF) OFTEN CO-OCCURS WITH SLEEP DISTURBANCE AND IS ONE OF THE MOST PERVASIVE TOXICITIES RESULTING FROM CANCER AND ITS TREATMENT. WE AND OTHER INVESTIGATORS HAVE PREVIOUSLY REPORTED THAT YOGA THERAPY CAN IMPROVE SLEEP QUALITY IN CANCER PATIENTS AND SURVIVORS. NO NATIONWIDE MULTICENTER PHASE III RANDOMIZED CONTROLLED TRIAL (RCT) HAS INVESTIGATED WHETHER YOGA THERAPY IMPROVES CRF OR WHETHER IMPROVEMENTS IN SLEEP MEDIATE THE EFFECT OF YOGA ON CRF. WE EXAMINED THE EFFECT OF A STANDARDIZED, 4-WEEK, YOGA THERAPY PROGRAM (YOGA FOR CANCER SURVIVORS [YOCAS]) ON CRF AND WHETHER YOCAS-INDUCED CHANGES IN SLEEP MEDIATED CHANGES IN CRF AMONG SURVIVORS. STUDY DESIGN AND METHODS: FOUR HUNDRED TEN CANCER SURVIVORS WERE RECRUITED TO A NATIONWIDE MULTICENTER PHASE III RCT COMPARING THE EFFECT OF YOCAS TO STANDARD SURVIVORSHIP CARE ON CRF AND EXAMINING THE MEDIATING EFFECTS OF CHANGES IN SLEEP, STEMMING FROM YOGA, ON CHANGES IN CRF. CRF WAS ASSESSED BY THE MULTIDIMENSIONAL FATIGUE SYMPTOM INVENTORY. SLEEP WAS ASSESSED VIA THE PITTSBURGH SLEEP QUALITY INDEX. BETWEEN- AND WITHIN-GROUP INTERVENTION EFFECTS ON CRF WERE ASSESSED BY ANALYSIS OF COVARIANCE AND 2-TAILED T TEST, RESPECTIVELY. PATH ANALYSIS WAS USED TO EVALUATE MEDIATION. RESULTS: YOCAS PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS IN CRF COMPARED WITH PARTICIPANTS IN STANDARD SURVIVORSHIP CARE AT POST-INTERVENTION ( P < .01). IMPROVEMENTS IN OVERALL SLEEP QUALITY AND REDUCTIONS IN DAYTIME DYSFUNCTION (EG, EXCESSIVE NAPPING) RESULTING FROM YOGA SIGNIFICANTLY MEDIATED THE EFFECT OF YOGA ON CRF (22% AND 37%, RESPECTIVELY, BOTH P < .01). CONCLUSIONS: YOCAS IS EFFECTIVE FOR TREATING CRF AMONG CANCER SURVIVORS; 22% TO 37% OF THE IMPROVEMENTS IN CRF FROM YOGA THERAPY RESULT FROM IMPROVEMENTS IN SLEEP QUALITY AND DAYTIME DYSFUNCTION. ONCOLOGISTS SHOULD CONSIDER PRESCRIBING YOGA TO CANCER SURVIVORS FOR TREATING CRF AND SLEEP DISTURBANCE.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
6 1370  42 IMPACT OF A STRUCTURED YOGA PROGRAM ON BLOOD PRESSURE REDUCTION AMONG HYPERTENSIVE PATIENTS: STUDY PROTOCOL FOR A PRAGMATIC RANDOMIZED MULTICENTER TRIAL IN PRIMARY HEALTH CARE SETTINGS IN NEPAL. BACKGROUND: HYPERTENSION CONTROL REMAINS A MAJOR GLOBAL CHALLENGE. THE BEHAVIORAL APPROACHES RECOMMENDED FOR BLOOD PRESSURE REDUCTION ARE STRESS REDUCTION, INCREASED EXERCISE AND HEALTHY DIETARY HABITS. SOME STUDY FINDINGS SUGGEST THAT YOGA HAS A BENEFICIAL EFFECT IN REDUCING BLOOD PRESSURE. HOWEVER, THE ROLE OF YOGA ON BLOOD PRESSURE HAS RECEIVED LITTLE ATTENTION IN EXISTING HEALTH CARE PRACTICES IN DEVELOPING COUNTRIES. THIS STUDY WILL BE CONDUCTED IN PRIMARY HEALTH CARE FACILITIES IN NEPAL TO ASSESS THE EFFECTIVENESS OF A PRAGMATIC YOGA INTERVENTION TO COMPLEMENT STANDARD PRACTICE IN FURTHER REDUCING BLOOD PRESSURE. METHODS: THIS WILL BE MULTICENTRIC, TWO ARMS, RANDOMIZED, NONBLINDED, PRAGMATIC TRIAL. IT WILL BE CONDUCTED IN SEVEN DISTRICT AYURVEDA HEALTH CENTERS (DAHCS) IN NEPAL BETWEEN JULY 2017 AND JUNE 2018. THE STUDY PARTICIPANTS WILL CONSIST OF HYPERTENSIVE PATIENTS WITH OR WITHOUT ANTIHYPERTENSIVE MEDICATION ATTENDING TO THE OUTPATIENT DEPARTMENT (OPD). ONE HUNDRED AND FORTY PARTICIPANTS WILL BE RANDOMIZED TO TREATMENT OR CONTROL GROUPS BY USING A STRATIFIED BLOCK RANDOMIZATION. AT THE STUDY SITE, THE TREATMENT ARM PARTICIPANTS WILL RECEIVE AN INTERVENTION CONSISTING OF FIVE DAYS OF STRUCTURED YOGA TRAINING AND PRACTICE OF THE SAME PACKAGE AT HOME WITH A RECOMMENDATION OF FIVE DAYS A WEEK FOR THE FOLLOWING 90 DAYS. BOTH THE INTERVENTION AND CONTROL GROUPS WILL RECEIVE TWO HOURS OF HEALTH EDUCATION ON LIFESTYLE MODIFICATIONS. THE PRIMARY OUTCOME OF THIS TRIAL WILL BE THE CHANGE IN SYSTOLIC BLOOD PRESSURE AND IT WILL BE ASSESSED AFTER 90 DAYS OF THE INTERVENTION. DISCUSSION: THIS STUDY WILL ESTABLISH THE EXTENT TO WHICH A YOGA INTERVENTION PACKAGE CAN HELP REDUCE BLOOD PRESSURE IN HYPERTENSIVE PATIENTS. IF PROVEN EFFECTIVE, STUDY FINDINGS MAY BE USED TO RECOMMEND THE GOVERNING BODIES AND OTHER STAKEHOLDERS FOR THE INTEGRATION OF YOGA IN THE NATIONAL HEALTHCARE SYSTEM FOR THE TREATMENT AND CONTROL OF HYPERTENSION. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRY- INDIA (CTRI); CTRI REG. NO- CTRI/2017/02/007822 . REGISTERED ON 10/02/2017.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
7  540  49 COMPLIANCE EFFECTS IN A RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: A METHODOLOGICAL STUDY. STUDY DESIGN: METHODOLOGICAL STUDY NESTED WITHIN A MULTICENTRE RANDOMISED CONTROLLED TRIAL (RCT) OF YOGA PLUS USUAL GENERAL PRACTITIONER (GP) CARE VS USUAL GP CARE FOR CHRONIC LOW BACK PAIN. OBJECTIVE: TO EXPLORE THE TREATMENT EFFECTS OF NON-COMPLIANCE USING THREE APPROACHES IN AN RCT EVALUATING YOGA FOR LOW BACK PAIN. SUMMARY OF BACKGROUND DATA: A LARGE MULTICENTRE RCT USING INTENTION-TO-TREAT (ITT) ANALYSIS FOUND THAT PARTICIPANTS WITH CHRONIC LOW BACK PAIN WHO WERE OFFERED A 12-WEEK PROGRESSIVE PROGRAMME OF YOGA PLUS USUAL GP CARE HAD BETTER BACK FUNCTION THAN THOSE OFFERED USUAL GP CARE ALONE. HOWEVER, ITT ANALYSIS CAN UNDERESTIMATE THE EFFECT OF TREATMENT IN THOSE WHO COMPLY WITH TREATMENT. AS SUCH, THE DATA WERE ANALYSED USING OTHER APPROACHES TO ASSESS THE PROBLEM OF NON-COMPLIANCE. THE MAIN OUTCOME MEASURE WAS THE SELF-REPORTED ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ). METHODS: COMPLIER AVERAGE CAUSAL EFFECT (CACE) ANALYSIS, PER-PROTOCOL ANALYSIS AND ON-TREATMENT ANALYSIS WERE CONDUCTED ON THE DATA OF PARTICIPANTS WHO WERE FULLY COMPLIANT, PREDEFINED AS ATTENDANCE OF AT LEAST THREE OF THE FIRST SIX SESSIONS AND AT LEAST THREE OTHER SESSIONS. THE ANALYSIS WAS REPEATED FOR PARTICIPANTS WHO HAD ATTENDED AT LEAST ONE YOGA SESSION (I.E. ANY COMPLIANCE), WHICH INCLUDED PARTICIPANTS WHO WERE FULLY COMPLIANT. EACH APPROACH WAS DESCRIBED, INCLUDING STRENGTHS AND WEAKNESSES, AND THE RESULTS OF THE DIFFERENT APPROACHES WERE COMPARED WITH THOSE OF THE ITT ANALYSIS. RESULTS: FOR THE PARTICIPANTS WHO WERE FULLY COMPLIANT (N=93, 60%), A LARGER BENEFICIAL TREATMENT EFFECT WAS SEEN USING CACE ANALYSIS COMPARED WITH PER-PROTOCOL, ON-TREATMENT AND ITT ANALYSES AT 3 AND 12 MONTHS. THE DIFFERENCE IN MEAN CHANGE IN RMDQ SCORE BETWEEN RANDOMISED GROUPS WAS -3.30 [95% CONFIDENCE INTERVAL (CI) -4.90 TO -1.70, P<0.001] AT 3 MONTHS AND -2.23 (95% CI -3.93 TO -0.53, P=0.010) AT 12 MONTHS FOR CACE ANALYSIS, -3.12 (95% CI -4.26 TO -1.98, P<0.001) AT 3 MONTHS AND -2.11 (95% CI -3.33 TO -0.89, P=0.001) AT 12 MONTHS FOR PER-PROTOCOL ANALYSIS, AND -2.91 (95% CI -4.06 TO -1.76, P<0.001) AT 3 MONTHS AND -2.10 (95% CI -3.31 TO -0.89, P=0.001) AT 12 MONTHS FOR ON-TREATMENT ANALYSIS. FOR THE PARTICIPANTS WHO DEMONSTRATED ANY COMPLIANCE (N=133, 85%), THE RESULTS WERE GENERALLY CONSISTENT WITH THE FULLY COMPLIANT GROUP AT 3 MONTHS, BUT THE TREATMENT EFFECT WAS SMALLER. THE DIFFERENCE IN MEAN CHANGE IN RMDQ SCORE BETWEEN RANDOMISED GROUPS WAS -2.45 (95% CI -3.67 TO -1.24) FOR CACE ANALYSIS, -2.30 (95% CI -3.43 TO 1.17) FOR PER-PROTOCOL ANALYSIS AND -2.15 (95% CI -3.25 TO -1.06) FOR ON-TREATMENT ANALYSIS, WHICH WAS SLIGHTLY LESS THAN THAT FOR ITT ANALYSIS. IN CONTRAST, AT 12 MONTHS, PER-PROTOCOL AND ON-TREATMENT ANALYSES SHOWED A LARGER TREATMENT EFFECT COMPARED WITH CACE AND ITT ANALYSES: PER PROTOCOL ANALYSIS -1.86 (95% CI -3.02 TO -0.71), ON-TREATMENT ANALYSIS -1.99 (95% CI -3.13 TO -0.86) AND CACE ANALYSIS -1.67 (95% CI -2.95 TO -0.40). CONCLUSION: ITT ANALYSIS ESTIMATED A SLIGHTLY SMALLER TREATMENT EFFECT IN PARTICIPANTS WHO COMPLIED WITH TREATMENT. WHEN EXAMINING COMPLIANCE, CACE ANALYSIS IS MORE RIGOROUS THAN PER-PROTOCOL AND ON-TREATMENT ANALYSES. USING CACE ANALYSIS, THE TREATMENT EFFECT WAS LARGER IN PARTICIPANTS WHO COMPLIED WITH TREATMENT COMPARED WITH PARTICIPANTS WHO WERE ALLOCATED TO TREATMENT, AND THE DIFFERENCE BETWEEN ITT AND CACE ANALYSES FOR THE FULLY COMPLIANT GROUP AT 3 MONTHS WAS SMALL BUT CLINICALLY IMPORTANT. PER-PROTOCOL AND ON-TREATMENT ANALYSES MAY PRODUCE UNRELIABLE ESTIMATES WHEN THE EFFECT OF TREATMENT IS SMALL. INTERNATIONAL STANDARD RANDOMISED TRIAL NUMBER REGISTER: ISRCTN 81079604.	2014	

8  518  44 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
9  953  55 EFFECTS OF A HEALTH WORKER-LED 3-MONTH YOGA INTERVENTION ON BLOOD PRESSURE OF HYPERTENSIVE PATIENTS: A RANDOMISED CONTROLLED MULTICENTRE TRIAL IN THE PRIMARY CARE SETTING. BACKGROUND: HYPERTENSION CONTROL REMAINS A MAJOR CHALLENGE GLOBALLY. A RECENT SYSTEMATIC REVIEW SUGGESTED THAT YOGA HAS BENEFICIAL EFFECTS ON REDUCING BLOOD PRESSURE. HOWEVER, THE ROLE OF YOGA IN HYPERTENSION MANAGEMENT IN PRIMARY HEALTH CARE HAS RECEIVED LITTLE ATTENTION, AND NO STUDIES HAVE EVALUATED THE IMPACT OF A YOGA PROGRAM FULLY DELIVERED BY HEALTH CARE STAFF ON HYPERTENSION. THIS STUDY, THEREFORE, ASSESSED THE EFFECTS OF A HEALTH WORKER-LED YOGA INTERVENTION ON BLOOD PRESSURE REDUCTION AMONG HYPERTENSIVES PATIENTS IN THE PRIMARY CARE SETTING. METHODS: THIS WAS A MULTICENTRIC, TWO-ARM, RANDOMISED TRIAL CONDUCTED AMONG HYPERTENSIVE PATIENTS IN SEVEN AYURVEDA HEALTH CENTRES IN NEPAL BETWEEN MARCH 2017 AND JUNE 2018. ONE HUNDRED AND TWENTY-ONE PARTICIPANTS WHO WERE ON OR WITHOUT MEDICATIONS WERE RANDOMISED TO INTERVENTION (N = 61) AND WAIT-LIST CONTROL (N = 60) GROUPS USING STRATIFIED BLOCK RANDOMISATION. PARTICIPANTS IN THE INTERVENTION ARM RECEIVED AN INTERVENTION CONSISTING OF AN INITIAL FIVE-DAY STRUCTURED YOGA TRAINING AT THE CENTRES AND THEN A FURTHER HOME-BASED PRACTICE OF YOGA FOR FIVE DAYS A WEEK FOR THE FOLLOWING 90 DAYS. BOTH INTERVENTION AND CONTROL GROUPS ALSO PARTICIPATED IN A 2-H HEALTH EDUCATION SESSION. THE PRIMARY OUTCOME OF THIS TRIAL WAS SYSTOLIC BLOOD PRESSURE AT 90-DAY FOLLOW-UP. DATA WERE ANALYSED ON AN INTENTION-TO-TREAT BASIS USING LINEAR MIXED-EFFECTS REGRESSION MODELS. RESULTS: WE INCLUDED ALL 121 STUDY PARTICIPANTS (INTERVENTION/CONTROL = 61/60) IN THE PRIMARY ANALYSIS (52.1% MALES; MEAN +/- SD AGE = 47.8 +/- 10.8 YEARS). THE DIFFERENCE IN SYSTOLIC BLOOD PRESSURE BETWEEN THE INTERVENTION GROUP AND THE CONTROL GROUP WAS - 7.66 MMHG (95% CI: - 10.4, - 4.93). FOR DIASTOLIC BLOOD PRESSURE, THE DIFFERENCE WAS - 3.86 MMHG (95% CI: - 6.65, - 1.06). NO ADVERSE EVENTS WERE REPORTED BY THE PARTICIPANTS. CONCLUSIONS: A YOGA PROGRAM FOR HYPERTENSIVE PATIENTS CONSISTING OF A FIVE-DAY TRAINING IN HEALTH CENTRES AND 90 DAYS OF PRACTICE AT HOME IS EFFECTIVE FOR REDUCING BLOOD PRESSURE. SIGNIFICANT BENEFITS FOR HYPERTENSIVE PATIENTS COULD BE EXPECTED IF SUCH PROGRAMMES WOULD BECOME A PART OF THE STANDARD TREATMENT PRACTICE. TRIAL REGISTRATION: THIS TRIAL WAS PROSPECTIVELY REGISTERED WITH THE CLINICAL TRIAL REGISTRY OF INDIA [ CTRI/2017/02/007822 ] ON 10/02/2017.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
10 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
11 2560  54 YOGA FOR CHRONIC LOW BACK PAIN: A RANDOMIZED TRIAL. BACKGROUND: PREVIOUS STUDIES INDICATE THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR CHRONIC OR RECURRENT LOW BACK PAIN. OBJECTIVE: TO COMPARE THE EFFECTIVENESS OF YOGA AND USUAL CARE FOR CHRONIC OR RECURRENT LOW BACK PAIN. DESIGN: PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL USING COMPUTER-GENERATED RANDOMIZATION CONDUCTED FROM APRIL 2007 TO MARCH 2010. OUTCOMES WERE ASSESSED BY POSTAL QUESTIONNAIRE. (INTERNATIONAL STANDARD RANDOMISED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN 81079604) SETTING: 13 NON-NATIONAL HEALTH SERVICE PREMISES IN THE UNITED KINGDOM. PATIENTS: 313 ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. INTERVENTION: YOGA (N = 156) OR USUAL CARE (N = 157). ALL PARTICIPANTS RECEIVED A BACK PAIN EDUCATION BOOKLET. THE INTERVENTION GROUP WAS OFFERED A 12-CLASS, GRADUALLY PROGRESSING YOGA PROGRAM DELIVERED BY 12 TEACHERS OVER 3 MONTHS. MEASUREMENTS: SCORES ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RMDQ) AT 3 (PRIMARY OUTCOME), 6, AND 12 (SECONDARY OUTCOMES) MONTHS; PAIN, PAIN SELF-EFFICACY, AND GENERAL HEALTH MEASURES AT 3, 6, AND 12 MONTHS (SECONDARY OUTCOMES). RESULTS: 93 (60%) PATIENTS OFFERED YOGA ATTENDED AT LEAST 3 OF THE FIRST 6 SESSIONS AND AT LEAST 3 OTHER SESSIONS. THE YOGA GROUP HAD BETTER BACK FUNCTION AT 3, 6, AND 12 MONTHS THAN THE USUAL CARE GROUP. THE ADJUSTED MEAN RMDQ SCORE WAS 2.17 POINTS (95% CI, 1.03 TO 3.31 POINTS) LOWER IN THE YOGA GROUP AT 3 MONTHS, 1.48 POINTS (CI, 0.33 TO 2.62 POINTS) LOWER AT 6 MONTHS, AND 1.57 POINTS (CI, 0.42 TO 2.71 POINTS) LOWER AT 12 MONTHS. THE YOGA AND USUAL CARE GROUPS HAD SIMILAR BACK PAIN AND GENERAL HEALTH SCORES AT 3, 6, AND 12 MONTHS, AND THE YOGA GROUP HAD HIGHER PAIN SELF-EFFICACY SCORES AT 3 AND 6 MONTHS BUT NOT AT 12 MONTHS. TWO OF THE 157 USUAL CARE PARTICIPANTS AND 12 OF THE 156 YOGA PARTICIPANTS REPORTED ADVERSE EVENTS, MOSTLY INCREASED PAIN. LIMITATION: THERE WERE MISSING DATA FOR THE PRIMARY OUTCOME (YOGA GROUP, N = 21; USUAL CARE GROUP, N = 18) AND DIFFERENTIAL MISSING DATA (MORE IN THE YOGA GROUP) FOR SECONDARY OUTCOMES. CONCLUSION: OFFERING A 12-WEEK YOGA PROGRAM TO ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN LED TO GREATER IMPROVEMENTS IN BACK FUNCTION THAN DID USUAL CARE. PRIMARY FUNDING SOURCE: ARTHRITIS RESEARCH UK.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
12 1650  43 MULTICENTER, RANDOMIZED CONTROLLED TRIAL OF YOGA FOR SLEEP QUALITY AMONG CANCER SURVIVORS. PURPOSE: THIRTY PERCENT TO 90% OF CANCER SURVIVORS REPORT IMPAIRED SLEEP QUALITY POST-TREATMENT, WHICH CAN BE SEVERE ENOUGH TO INCREASE MORBIDITY AND MORTALITY. LIFESTYLE INTERVENTIONS, SUCH AS EXERCISE, ARE RECOMMENDED IN CONJUNCTION WITH DRUGS AND COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF IMPAIRED SLEEP. PRELIMINARY EVIDENCE INDICATES THAT YOGA-A MIND-BODY PRACTICE AND FORM OF EXERCISE-MAY IMPROVE SLEEP AMONG CANCER SURVIVORS. THE PRIMARY AIM OF THIS RANDOMIZED, CONTROLLED CLINICAL TRIAL WAS TO DETERMINE THE EFFICACY OF A STANDARDIZED YOGA INTERVENTION COMPARED WITH STANDARD CARE FOR IMPROVING GLOBAL SLEEP QUALITY (PRIMARY OUTCOME) AMONG POST-TREATMENT CANCER SURVIVORS. PATIENTS AND METHODS: IN ALL, 410 SURVIVORS SUFFERING FROM MODERATE OR GREATER SLEEP DISRUPTION BETWEEN 2 AND 24 MONTHS AFTER SURGERY, CHEMOTHERAPY, AND/OR RADIATION THERAPY WERE RANDOMLY ASSIGNED TO STANDARD CARE OR STANDARD CARE PLUS THE 4-WEEK YOGA INTERVENTION. THE YOGA INTERVENTION USED THE YOGA FOR CANCER SURVIVORS (YOCAS) PROGRAM CONSISTING OF PRANAYAMA (BREATHING EXERCISES), 16 GENTLE HATHA AND RESTORATIVE YOGA ASANAS (POSTURES), AND MEDITATION. PARTICIPANTS ATTENDED TWO 75-MINUTE SESSIONS PER WEEK. SLEEP QUALITY WAS ASSESSED BY USING THE PITTSBURGH SLEEP QUALITY INDEX AND ACTIGRAPHY PRE- AND POSTINTERVENTION. RESULTS: IN ALL, 410 SURVIVORS WERE ACCRUED (96% FEMALE; MEAN AGE, 54 YEARS; 75% HAD BREAST CANCER). YOGA PARTICIPANTS DEMONSTRATED GREATER IMPROVEMENTS IN GLOBAL SLEEP QUALITY AND, SECONDARILY, SUBJECTIVE SLEEP QUALITY, DAYTIME DYSFUNCTION, WAKE AFTER SLEEP ONSET, SLEEP EFFICIENCY, AND MEDICATION USE AT POSTINTERVENTION (ALL P </= .05) COMPARED WITH STANDARD CARE PARTICIPANTS. CONCLUSION: YOGA, SPECIFICALLY THE YOCAS PROGRAM, IS A USEFUL TREATMENT FOR IMPROVING SLEEP QUALITY AND REDUCING SLEEP MEDICATION USE AMONG CANCER SURVIVORS.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
13  162  46 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE.	2010	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
14 2852  51 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
15 2845  40 YOGA, EURYTHMY THERAPY AND STANDARD PHYSIOTHERAPY (YES-TRIAL) FOR PATIENTS WITH CHRONIC NON-SPECIFIC LOW BACK PAIN: A THREE-ARMED RANDOMIZED CONTROLLED TRIAL. WE AIMED TO EVALUATE THE EFFECTS OF YOGA AND EURYTHMY THERAPY COMPARED TO CONVENTIONAL PHYSIOTHERAPY EXERCISES IN PATIENTS WITH CHRONIC LOW BACK PAIN. IN A THREE-ARMED, MULTICENTRE, RANDOMIZED CONTROLLED TRIAL, PATIENTS WITH CHRONIC LOW BACK PAIN WERE TREATED FOR 8 WEEKS IN GROUP SESSIONS (75 MINUTES ONCE PER WEEK). PRIMARY OUTCOME WAS PATIENTS' PHYSICAL DISABILITY (MEASURED BY RMDQ) FROM BASELINE TO WEEK 8. SECONDARY OUTCOME VARIABLES WERE PAIN INTENSITY AND PAIN-RELATED BOTHERSOMENESS (VAS), HEALTH-RELATED QUALITY OF LIFE (SF-12) AND LIFE SATISFACTION (BMLSS). OUTCOMES WERE ASSESSED AT BASELINE, AFTER THE INTERVENTION AT 8 WEEKS AND AT A 16-WEEK FOLLOW UP. DATA OF 274 PARTICIPANTS WERE USED FOR STATISTICAL ANALYSES. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE THREE GROUPS FOR THE PRIMARY AND ALL SECONDARY OUTCOMES. IN ALL GROUPS, RMDQ DECREASED COMPARABLY AT 8 WEEKS, BUT DID NOT REACH CLINICAL MEANINGFULNESS. PAIN INTENSITY AND PAIN-RELATED BOTHERSOMENESS DECREASED, WHILE QUALITY OF LIFE INCREASED IN ALL 3 GROUPS. IN EXPLORATIVE GENERAL LINEAR MODELS FOR THE SF-12'S MENTAL HEALTH COMPONENT PARTICIPANTS IN THE EURYTHMY ARM BENEFITTED SIGNIFICANTLY MORE COMPARED TO PHYSIOTHERAPY AND YOGA. FURTHERMORE, WITHIN-GROUP ANALYSES SHOWED IMPROVEMENTS OF SF-12 MENTAL SCORE FOR YOGA AND EURYTHMY THERAPY ONLY. ALL INTERVENTIONS WERE SAFE. CLINICAL TRIALS REGISTER: DRKS-ID: DRKS00004651 PERSPECTIVE: THIS ARTICLE PRESENTS THE RESULTS OF A MULTICENTRE THREE-ARMED RANDOMIZED CONTROLLED TRIAL ON THE CLINICAL EFFECTS OF THREE 8-WEEK PROGRAMS IN PATIENTS WITH CHRONIC LOW BACK PAIN. COMPARED TO THE 'GOLD STANDARD' OF CONVENTIONAL PHYSIOTHERAPEUTIC EXERCISES, EURYTHMY THERAPY AND YOGA THERAPY LEAD TO COMPARABLE SYMPTOMATIC IMPROVEMENTS IN PATIENTS WITH CHRONIC LOW BACK PAIN. HOWEVER, THE WITHIN-GROUP EFFECT SIZES WERE SMALL TO MODERATE AND DID NOT REACH CLINICAL MEANINGFULNESS ON PATIENTS' PHYSICAL DISABILITY (RMDQ).	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
16 2764  41 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
17 2093  35 THE EFFECT OF YOCAS(C)(R) YOGA FOR MUSCULOSKELETAL SYMPTOMS AMONG BREAST CANCER SURVIVORS ON HORMONAL THERAPY. UP TO 50% OF BREAST CANCER SURVIVORS ON AROMATASE INHIBITOR THERAPY REPORT MUSCULOSKELETAL SYMPTOMS SUCH AS JOINT AND MUSCLE PAIN, SIGNIFICANTLY IMPACTING TREATMENT ADHERENCE AND DISCONTINUATION RATES. WE CONDUCTED A SECONDARY DATA ANALYSIS OF A NATIONWIDE, MULTI-SITE, PHASE II/III RANDOMIZED, CONTROLLED, CLINICAL TRIAL EXAMINING THE EFFICACY OF YOGA FOR IMPROVING MUSCULOSKELETAL SYMPTOMS AMONG BREAST CANCER SURVIVORS CURRENTLY RECEIVING HORMONE THERAPY (AROMATASE INHIBITORS [AI] OR TAMOXIFEN [TAM]). BREAST CANCER SURVIVORS CURRENTLY RECEIVING AI (N = 95) OR TAM (N = 72) WITH NO PARTICIPATION IN YOGA DURING THE PREVIOUS 3 MONTHS WERE RANDOMIZED INTO 2 ARMS: (1) STANDARD CARE MONITORING AND (2) STANDARD CARE PLUS THE 4-WEEK YOGA INTERVENTION (2X/WEEK; 75 MIN/SESSION) AND INCLUDED IN THIS ANALYSIS. THE YOGA INTERVENTION UTILIZED THE UR YOGA FOR CANCER SURVIVORS (YOCAS(C)((R))) PROGRAM CONSISTING OF BREATHING EXERCISES, 18 GENTLE HATHA AND RESTORATIVE YOGA POSTURES, AND MEDITATION. MUSCULOSKELETAL SYMPTOMS WERE ASSESSED PRE- AND POST-INTERVENTION. AT BASELINE, AI USERS REPORTED HIGHER LEVELS OF GENERAL PAIN, MUSCLE ACHES, AND TOTAL PHYSICAL DISCOMFORT THAN TAM USERS (ALL P </= 0.05). AMONG ALL BREAST CANCER SURVIVORS ON HORMONAL THERAPY, PARTICIPANTS IN THE YOGA GROUP DEMONSTRATED GREATER REDUCTIONS IN MUSCULOSKELETAL SYMPTOMS SUCH AS GENERAL PAIN, MUSCLE ACHES AND TOTAL PHYSICAL DISCOMFORT FROM PRE- TO POST-INTERVENTION THAN THE CONTROL GROUP (ALL P </= 0.05). THE SEVERITY OF MUSCULOSKELETAL SYMPTOMS WAS HIGHER FOR AI USERS COMPARED TO TAM USERS. AMONG BREAST CANCER SURVIVORS ON HORMONE THERAPY, THE BRIEF COMMUNITY-BASED YOCAS(C)(R) INTERVENTION SIGNIFICANTLY REDUCED GENERAL PAIN, MUSCLE ACHES, AND PHYSICAL DISCOMFORT.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
18  521  54 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS.	2005	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
19 2824  37 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
20 2867  33 YOGA-BASED LIFESTYLE TREATMENT AND COMPOSITE TREATMENT GOALS IN TYPE 2 DIABETES IN A RURAL SOUTH INDIAN SETUP- A RETROSPECTIVE STUDY. THIS MULTICENTRE RETROSPECTIVE STUDY EXAMINED THE EFFECTS OF ADJUNCT YOGA-TREATMENT IN ACHIEVING COMPOSITE CARDIOVASCULAR GOALS FOR TYPE 2 DIABETES (T2D), SET FORTH BY THE AMERICAN DIABETES ASSOCIATION (ADA) IN RURAL INDIAN SETTINGS. RECORDS WERE EXTRACTED FOR 146 T2D PATIENTS, AGED >/=20-70 YEARS, AND TREATED UNDER THE "APOLLO TOTAL HEALTH PROGRAMME" FOR RURAL DIABETES MANAGEMENT, FOR THE PERIOD APRIL 2016 TO NOVEMBER 2016. THE STUDY COHORT COMPRISED OF TWO TREATMENT GROUPS (N = 73 EACH); NON-YOGA GROUP (STANDARD OF CARE) AND YOGA GROUP (ADJUNCT YOGA-TREATMENT). PROPENSITY SCORE MATCHING WAS APPLIED BETWEEN THE STUDY GROUPS TO DEFINE THE COHORT. COMPOSITE CARDIOVASCULAR SCORES WERE BASED ON THE COMBINATION OF INDIVIDUAL ADA GOALS; A1C < 7%, BLOOD PRESSURE (BP) < 140/90 MMHG, STRINGENT BP (<130/80 MMHG) AND LIPID, LDL-C < 100 MG/DL [RISK FACTOR FOR ATHEROSCLEROTIC CARDIOVASCULAR DISEASE]. LOGISTIC REGRESSION WAS USED TO COMPARE BETWEEN THE TWO TREATMENT GROUPS. COMPARED TO STANDARD OF CARE, ADJUNCT YOGA-TREATMENT WAS FOUND TO SIGNIFICANTLY FACILITATE THE ATTAINMENT OF ADA COMPOSITE SCORE BY 8-FOLD; A1C, ~2-FOLD; LDL-C, ~2-FOLD; BP < 140/90 MMHG AND <130/80 MMHG BY ~8-AND ~6-FOLD RESPECTIVELY. THIS STUDY PROVIDES THE FIRST EVIDENCE FOR SIGNIFICANT EFFICACY OF ADJUNCT YOGA-TREATMENT FOR THE ATTAINMENT OF FAVOURABLE TREATMENT GOALS FOR T2D IN RURAL INDIAN SETTINGS. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2020/02/0232790.	2020