1  900 158 EFFECTIVENESS AND COST-EFFECTIVENESS OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAM FOLLOWING ACUTE MYOCARDIAL INFARCTION: STUDY RATIONALE AND DESIGN OF A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CARDIAC REHABILITATION (CR) IS A STANDARD TREATMENT FOR SECONDARY PREVENTION OF ACUTE MYOCARDIAL INFARCTION (AMI) IN HIGH INCOME COUNTRIES (HICS), BUT IT IS INACCESSIBLE TO MOST PATIENTS IN INDIA DUE TO HIGH COSTS AND SKILLS REQUIRED FOR MULTIDISCIPLINARY CR TEAMS. WE DEVELOPED A LOW-COST AND SCALABLE CR PROGRAM BASED ON CULTURALLY-ACCEPTABLE PRACTICE OF YOGA (YOGA-CARE). IN THIS PAPER, WE REPORT THE RATIONALE AND DESIGN FOR EVALUATION OF ITS EFFECTIVENESS AND COST-EFFECTIVENESS. METHODS: THIS IS A MULTI-CENTER, SINGLE-BLIND, TWO-ARM PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL ACROSS 22 CARDIAC CARE HOSPITALS IN INDIA. FOUR THOUSAND PATIENTS AGED 18-80YEARS WITH AMI WILL BE RECRUITED AND RANDOMIZED 1:1 TO RECEIVE YOGA-CARE PROGRAM (13 SESSIONS SUPERVISED BY AN INSTRUCTOR AND ENCOURAGEMENT TO SELF-PRACTICE DAILY) OR ENHANCED STANDARD CARE (3 SESSIONS OF HEALTH EDUCATION) DELIVERED OVER A PERIOD OF THREE MONTHS. PARTICIPANTS WILL BE FOLLOWED 3-MONTHLY TILL THE END OF THE TRIAL. THE CO-PRIMARY OUTCOMES ARE A) TIME TO OCCURRENCE OF FIRST CARDIOVASCULAR EVENT (COMPOSITE OF ALL-CAUSE MORTALITY, NON-FATAL MYOCARDIAL INFARCTION, NON-FATAL STROKE AND EMERGENCY CARDIOVASCULAR HOSPITALIZATION), AND B) QUALITY OF LIFE (EURO-QOL-5L) AT 12WEEKS. SECONDARY OUTCOMES INCLUDE NEED FOR REVASCULARIZATION PROCEDURES, RETURN TO PRE-INFARCT ACTIVITIES, TOBACCO CESSATION, MEDICATION ADHERENCE, AND COST-EFFECTIVENESS OF THE INTERVENTION. CONCLUSION: THIS TRIAL WILL ALONE CONTRIBUTE >20% PARTICIPANTS TO EXISTING META-ANALYSES OF RANDOMIZED TRIALS OF CR WORLDWIDE. IF YOGA-CARE IS FOUND TO BE EFFECTIVE, IT HAS THE POTENTIAL TO SAVE MILLIONS OF LIVES AND TRANSFORM CARE OF AMI PATIENTS IN INDIA AND OTHER LOW AND MIDDLE INCOME COUNTRY SETTINGS.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
2  614  52 DEVELOPMENT OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAMME FOR SECONDARY PREVENTION OF MYOCARDIAL INFARCTION. CARDIAC REHABILITATION (CR) AFTER MYOCARDIAL INFARCTION IS HIGHLY EFFECTIVE. IT IS UNAVAILABLE IN PUBLIC HOSPITALS IN INDIA DUE TO LIMITED RESOURCES. OUR OBJECTIVE WAS TO DEVELOP A SCALABLE MODEL OF CR FOR INDIA BASED ON YOGA, WHICH COULD ALSO APPEAL TO SOME GROUPS WITH LOW UPTAKE OF CR (E.G., ETHNIC MINORITIES, WOMEN, AND OLDER PEOPLE) GLOBALLY. THE INTERVENTION WAS DEVELOPED USING A STRUCTURED PROCESS. A LITERATURE REVIEW AND CONSULTATIONS WITH YOGA EXPERTS, CR EXPERTS, AND POSTMYOCARDIAL INFARCTION PATIENTS WERE CONDUCTED TO SYSTEMATICALLY IDENTIFY AND SHORTLIST APPROPRIATE YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, MEDITATION AND RELAXATION PRACTICES, AND LIFESTYLE CHANGES, WHICH WERE INCORPORATED INTO A CONVENTIONAL CR FRAMEWORK. THE DRAFT INTERVENTION WAS FURTHER REFINED BASED ON THE FEEDBACK FROM AN INTERNAL STAKEHOLDER GROUP AND AN EXTERNAL PANEL OF INTERNATIONAL EXPERTS, BEFORE BEING PILOTED WITH YOGA INSTRUCTORS AND PATIENTS WITH MYOCARDIAL INFARCTION. A FOUR-PHASE YOGA-BASED CR (YOGA-CARE) PROGRAMME WAS DEVELOPED FOR DELIVERY BY A SINGLE YOGA INSTRUCTOR WITH BASIC TRAINING. THE PROGRAMME CONSISTS OF A TOTAL OF 13 INSTRUCTOR-LED SESSIONS (2 INDIVIDUAL AND 11 GROUP) OVER A 3-MONTH PERIOD. GROUP SESSIONS INCLUDE GUIDED PRACTICE OF YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, AND MEDITATION AND RELAXATION PRACTICES, AND SUPPORT FOR THE LIFESTYLE CHANGE AND COPING THROUGH A MODERATED DISCUSSION. PATIENTS ARE ENCOURAGED TO SELF-PRACTICE DAILY AT HOME AND CONTINUE LONG-TERM WITH THE HELP OF A BOOKLET AND DIGITAL VIDEO DISC (DVD). FAMILY MEMBERS/CARERS ARE ENCOURAGED TO JOIN THROUGHOUT. IN CONCLUSION, A NOVEL YOGA-BASED CR PROGRAMME HAS BEEN DEVELOPED, WHICH PROMISES TO PROVIDE A SCALABLE CR SOLUTION FOR INDIA AND AN ALTERNATIVE CHOICE FOR CR GLOBALLY. IT IS CURRENTLY BEING EVALUATED IN A LARGE MULTICENTRE RANDOMISED CONTROLLED TRIAL ACROSS INDIA.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
3 2857  70 YOGA-BASED CARDIAC REHABILITATION AFTER ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL. BACKGROUND: GIVEN THE SHORTAGE OF CARDIAC REHABILITATION (CR) PROGRAMS IN INDIA AND POOR UPTAKE WORLDWIDE, THERE IS AN URGENT NEED TO FIND ALTERNATIVE MODELS OF CR THAT ARE INEXPENSIVE AND MAY OFFER CHOICE TO SUBGROUPS WITH POOR UPTAKE (E.G., WOMEN AND ELDERLY). OBJECTIVES: THIS STUDY SOUGHT TO EVALUATE THE EFFECTS OF YOGA-BASED CR (YOGA-CARE) ON MAJOR CARDIOVASCULAR EVENTS AND SELF-RATED HEALTH IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL. METHODS: THE TRIAL WAS CONDUCTED IN 24 MEDICAL CENTERS ACROSS INDIA. THIS STUDY RECRUITED 3,959 PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITH A MEDIAN AND MINIMUM FOLLOW-UP OF 22 AND 6 MONTHS. PATIENTS WERE INDIVIDUALLY RANDOMIZED TO RECEIVE EITHER A YOGA-CARE PROGRAM (N = 1,970) OR ENHANCED STANDARD CARE INVOLVING EDUCATIONAL ADVICE (N = 1,989). THE CO-PRIMARY OUTCOMES WERE: 1) FIRST OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) (COMPOSITE OF ALL-CAUSE MORTALITY, MYOCARDIAL INFARCTION, STROKE, OR EMERGENCY CARDIOVASCULAR HOSPITALIZATION); AND 2) SELF-RATED HEALTH ON THE EUROPEAN QUALITY OF LIFE-5 DIMENSIONS-5 LEVEL VISUAL ANALOGUE SCALE AT 12 WEEKS. RESULTS: MACE OCCURRED IN 131 (6.7%) PATIENTS IN THE YOGA-CARE GROUP AND 146 (7.4%) PATIENTS IN THE ENHANCED STANDARD CARE GROUP (HAZARD RATIO WITH YOGA-CARE: 0.90; 95% CONFIDENCE INTERVAL [CI]: 0.71 TO 1.15; P = 0.41). SELF-RATED HEALTH WAS 77 IN YOGA-CARE AND 75.7 IN THE ENHANCED STANDARD CARE GROUP (BASELINE-ADJUSTED MEAN DIFFERENCE IN FAVOR OF YOGA-CARE: 1.5; 95% CI: 0.5 TO 2.5; P = 0.002). THE YOGA-CARE GROUP HAD GREATER RETURN TO PRE-INFARCT ACTIVITIES, BUT THERE WAS NO DIFFERENCE IN TOBACCO CESSATION OR MEDICATION ADHERENCE BETWEEN THE TREATMENT GROUPS (SECONDARY OUTCOMES). CONCLUSIONS: YOGA-CARE IMPROVED SELF-RATED HEALTH AND RETURN TO PRE-INFARCT ACTIVITIES AFTER ACUTE MYOCARDIAL INFARCTION, BUT THE TRIAL LACKED STATISTICAL POWER TO SHOW A DIFFERENCE IN MACE. YOGA-CARE MAY BE AN OPTION WHEN CONVENTIONAL CR IS UNAVAILABLE OR UNACCEPTABLE TO INDIVIDUALS. (A STUDY ON EFFECTIVENESS OF YOGA BASED CARDIAC REHABILITATION PROGRAMME IN INDIA AND UNITED KINGDOM; CTRI/2012/02/002408).	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
4 1153  30 ENHANCING THE APPEAL OF CARDIAC REHABILITATION FOR WOMEN: DEVELOPMENT AND PILOT TESTING OF A WOMEN-ONLY YOGA CARDIAC REHABILITATION PROGRAMME. AIMS: DESPITE ITS DEMONSTRATED BENEFITS, CARDIAC REHABILITATION (CR) ATTENDANCE, AND COMPLETION IS SUBOPTIMAL, PARTICULARLY IN WOMEN. THE AIMS OF THIS STUDY WERE (I) TO DEVELOP AND PILOT TEST A WOMEN-ONLY YOGA-BASED CR PROGRAMME (THE WOMEN'S YOGA CR PROGRAMME; WYCRP); (II) TO INVESTIGATE PROGRAMME ACCEPTABILITY; AND (III) TO INVESTIGATE ATTENDANCE AND COMPLETION OF THE WYCRP AND CONTINUATION TO PHASE III COMMUNITY-BASED CR. METHODS AND RESULTS: WOMEN ELIGIBLE FOR CR AT A TERTIARY HOSPITAL IN MELBOURNE, AUSTRALIA WERE RECRUITED. OVER A 6-MONTH PERIOD IN 2019, THEY WERE OFFERED THE WYCRP OR USUAL CR. THE WYCRP INVOLVED ATTENDANCE AT A 1-H YOGA SESSION FOLLOWING THE USUAL 1-H MIXED-SEX EDUCATION SESSION, OVER A 7-WEEK PERIOD. PARTICIPANTS COMPLETED PRE- AND POST-PROGRAMME QUESTIONNAIRES AND ATTENDED FOCUS GROUPS TO ASSESS PROGRAMME ACCEPTABILITY. RATES OF ATTENDANCE, COMPLETION, AND CONTINUATION FOR THE WYCRP WERE RECORDED AND COMPARED TO THOSE FOR THE STANDARD CR PROGRAMME OFFERED IN 2018. IN TOTAL, 27 WOMEN WERE ELIGIBLE FOR THE STUDY AND ATTENDED THE INITIAL CR ASSESSMENT. OF THOSE, 22 (81%) ATTENDED THE WYCRP, 1 (4%) ATTENDED USUAL CR, AND 4 (15%) DID NOT ATTEND CR. RATINGS OF PROGRAMME ACCEPTABILITY WERE CONSISTENTLY POSITIVE; QUALITATIVE COMMENTS HIGHLIGHTED BOTH PHYSICAL AND EMOTIONAL BENEFITS. WHILE ATTENDANCE AT THE WYCRP WAS NOT SIGNIFICANTLY HIGHER THAN FOR USUAL CR THE PREVIOUS YEAR (81% VS. 76%; P = 0.40), CR COMPLETION, AND CONTINUATION WERE (95% VS. 56%; P = 0.02, AND 72% VS. 12%; P < 0.001, RESPECTIVELY). CONCLUSION: THIS PILOT STUDY HAS DEMONSTRATED THAT WOMEN-ONLY YOGA-BASED CR IS APPEALING TO WOMEN AND CAN IMPROVE WOMEN'S CR COMPLETION AND CONTINUATION. THESE PRELIMINARY FINDINGS SUPPORT FURTHER DEVELOPMENT OF WOMEN-ONLY AND YOGA-BASED CR OPTIONS.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
5 2395  44 YOGA AND CARDIOVASCULAR HEALTH TRIAL (YACHT): A UK-BASED RANDOMISED MECHANISTIC STUDY OF A YOGA INTERVENTION PLUS USUAL CARE VERSUS USUAL CARE ALONE FOLLOWING AN ACUTE CORONARY EVENT. OBJECTIVE: TO DETERMINE THE EFFECTS OF YOGA PRACTICE ON SUBCLINICAL CARDIOVASCULAR MEASURES, RISK FACTORS AND NEURO-ENDOCRINE PATHWAYS IN PATIENTS UNDERGOING CARDIAC REHABILITATION (CR) FOLLOWING ACUTE CORONARY EVENTS. DESIGN: 3-MONTH, TWO-ARM (YOGA +USUAL CARE VS USUAL CARE ALONE) PARALLEL RANDOMISED MECHANISTIC STUDY. SETTING: ONE GENERAL HOSPITAL AND TWO PRIMARY CARE CR CENTRES IN LONDON. ASSESSMENTS WERE CONDUCTED AT IMPERIAL COLLEGE LONDON. PARTICIPANTS: 80 PARTICIPANTS, AGED 35-80 YEARS (68% MEN, 60% SOUTH ASIAN) REFERRED TO CR PROGRAMMES 2012-2014. INTERVENTION: A CERTIFIED YOGA TEACHER CONDUCTED YOGA CLASSES WHICH INCLUDED EXERCISES IN STRETCHING, BREATHING, HEALING IMAGERY AND DEEP RELAXATION. IT WAS PRE-SPECIFIED THAT AT LEAST 18 YOGA CLASSES WERE ATTENDED FOR INCLUSION IN ANALYSIS. PARTICIPANTS AND PARTNERS IN BOTH GROUPS WERE INVITED TO ATTEND WEEKLY A 6- TO 12-WEEK LOCAL STANDARD UK NATIONAL HEALTH SERVICE CR PROGRAMME. MAIN OUTCOME MEASURES: (I) ESTIMATED LEFT VENTRICULAR FILLING PRESSURE (E/E'), (II) DISTANCE WALKED, FATIGUE AND BREATHLESSNESS IN A 6 MIN WALK TEST, (III) BLOOD PRESSURE, HEART RATE AND ESTIMATED PEAK VO2 FOLLOWING A 3 MIN STEP-TEST. EFFECTS ON THE HYPOTHALAMUS-PITUITARY-ADRENAL AXIS, AUTONOMIC FUNCTION, BODY FAT, BLOOD LIPIDS AND GLUCOSE, STRESS AND GENERAL HEALTH WERE ALSO EXPLORED. RESULTS: 25 PARTICIPANTS IN THE YOGA + USUAL CARE GROUP AND 35 PARTICIPANTS IN THE USUAL CARE GROUP COMPLETED THE STUDY. FOLLOWING THE 3-MONTH INTERVENTION PERIOD, E/E' WAS NOT IMPROVED BY YOGA (E/E': BETWEEN-GROUP DIFFERENCE: YOGA MINUS USUAL CARE:-0.40 (-1.38, 0.58). EXERCISE TESTING AND SECONDARY OUTCOMES ALSO SHOWED NO BENEFITS OF YOGA. CONCLUSIONS: IN THIS SMALL UK-BASED RANDOMISED MECHANISTIC STUDY, WITH 60 COMPLETING PARTICIPANTS (OF WHOM 25 WERE IN THE YOGA + USUAL CARE GROUP), WE FOUND NO DISCERNIBLE IMPROVEMENT ASSOCIATED WITH THE ADDITION OF A STRUCTURED 3-MONTH YOGA INTERVENTION TO USUAL CR CARE IN KEY CARDIOVASCULAR AND NEUROENDOCRINE MEASURES SHOWN TO BE RESPONSIVE TO YOGA IN PREVIOUS MECHANISTIC STUDIES. TRIAL REGISTRATION NUMBER: NCT01597960; PRE-RESULTS.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                          
6 2598  44 YOGA FOR OLDER ADULTS WITH MULTIMORBIDITY (THE GENTLE YEARS YOGA TRIAL): STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL. BACKGROUND: MULTIMORBIDITY IS COMMON IN OLDER ADULTS AND ASSOCIATED WITH HIGH LEVELS OF ILLNESS BURDEN AND HEALTHCARE EXPENDITURE. THE EVIDENCE BASE FOR HOW TO MANAGE OLDER ADULTS WITH MULTIMORBIDITY IS WEAK. YOGA MIGHT BE A USEFUL INTERVENTION BECAUSE IT HAS THE POTENTIAL TO IMPROVE HEALTH-RELATED QUALITY OF LIFE, PHYSICAL FUNCTIONING, AND SEVERAL MEDICAL CONDITIONS. THE BRITISH WHEEL OF YOGA'S GENTLE YEARS YOGA(C) (GYY) PROGRAMME WAS DEVELOPED SPECIFICALLY FOR OLDER ADULTS, INCLUDING THOSE WITH CHRONIC MEDICAL CONDITIONS. DATA FROM A PILOT TRIAL SUGGESTED FEASIBILITY OF USING GYY IN THIS POPULATION, BUT ITS EFFECTIVENESS AND COST-EFFECTIVENESS REMAIN UNCERTAIN. METHODS: THIS IS A MULTI-SITE, INDIVIDUALLY RANDOMISED, SUPERIORITY TRIAL WITH AN EMBEDDED PROCESS EVALUATION AND AN ECONOMIC ANALYSIS OF COST-EFFECTIVENESS. THE TRIAL WILL COMPARE AN EXPERIMENTAL STRATEGY OF OFFERING A 12-WEEK GYY PROGRAMME AGAINST A CONTROL STRATEGY OF NO OFFER IN COMMUNITY-DWELLING ADULTS AGED 65 OR OVER WHO HAVE MULTIMORBIDITY, DEFINED AS HAVING TWO OR MORE CHRONIC CONDITIONS FROM A PREDEFINED LIST. THE PRIMARY OUTCOME IS HEALTH-RELATED QUALITY OF LIFE MEASURED USING THE EQ-5D-5L, THE PRIMARY ENDPOINT BEING THE OVERALL DIFFERENCE OVER 12 MONTHS. BOTH GROUPS WILL CONTINUE TO BE ABLE TO ACCESS THEIR USUAL CARE FROM PRIMARY, SECONDARY, COMMUNITY, AND SOCIAL SERVICES. PARTICIPANTS, CARE PROVIDERS, AND YOGA TEACHERS WILL NOT BE BLINDED TO THE ALLOCATED INTERVENTION. OUTCOME MEASURES ARE PRIMARILY SELF-REPORTED. THE ANALYSIS WILL FOLLOW INTENTION-TO-TREAT PRINCIPLES. DISCUSSION: THIS PRAGMATIC RANDOMISED CONTROLLED TRIAL WILL DEMONSTRATE IF THE GYY PROGRAMME IS AN EFFECTIVE, COST-EFFECTIVE, AND VIABLE ADDITION TO THE MANAGEMENT OF OLDER ADULTS WITH MULTIMORBIDITY. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . REGISTERED ON 18 MARCH 2019.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
7  132  45 A PRAGMATIC MULTICENTERED RANDOMIZED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: ECONOMIC EVALUATION. STUDY DESIGN: MULTICENTERED RANDOMIZED CONTROLLED TRIAL WITH QUALITY OF LIFE AND RESOURCE USE DATA COLLECTED. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE COST-EFFECTIVENESS OF YOGA INTERVENTION PLUS USUAL CARE COMPARED WITH USUAL CARE ALONE FOR CHRONIC OR RECURRENT LOW BACK PAIN. SUMMARY OF BACKGROUND DATA: YOGA HAS BEEN SHOWN AS AN EFFECTIVE INTERVENTION FOR TREATING CHRONIC OR RECURRENT LOW BACK PAIN. HOWEVER, THERE IS LITTLE EVIDENCE ON ITS COST-EFFECTIVENESS. THE DATA ARE EXTRACTED FROM A PRAGMATIC, MULTICENTERED, RANDOMIZED CONTROLLED TRIAL THAT HAS BEEN CONDUCTED TO EVALUATE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF A 12-WEEK PROGRESSIVE PROGRAM OF YOGA PLUS USUAL CARE IN PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. METHODS: WITH THIS TRIAL DATA, A COST-EFFECTIVENESS ANALYSIS DURING THE TIME PERIOD OF 12 MONTHS FROM BOTH PERSPECTIVES OF THE UK NATIONAL HEALTH SERVICE AND THE SOCIETAL IS PRESENTED. MAIN OUTCOME MEASURE IS AN INCREMENTAL COST PER QUALITY-ADJUSTED LIFE-YEAR (QALY). RESULTS: FROM THE PERSPECTIVE OF THE U.K. NATIONAL HEALTH SERVICE, YOGA INTERVENTION YIELDS AN INCREMENTAL COST-EFFECTIVENESS RATIO OF POUND13,606 PER QALY. GIVEN A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000, THE PROBABILITY OF YOGA INTERVENTION BEING COST-EFFECTIVE IS 72%. FROM THE PERSPECTIVE OF THE SOCIETY, YOGA INTERVENTION IS A DOMINANT TREATMENT COMPARED WITH USUAL CARE ALONE. THIS RESULT IS SURROUNDED BY FEWER UNCERTAINTIES-THE PROBABILITY OF YOGA BEING COST-EFFECTIVE REACHES 95% AT A WILLINGNESS TO PAY FOR AN ADDITIONAL QALY OF POUND20,000. SENSITIVE ANALYSES SUGGEST THE SAME RESULTS THAT YOGA INTERVENTION IS LIKELY TO BE COST-EFFECTIVE IN BOTH PERSPECTIVES. CONCLUSION: ON THE BASIS OF THIS TRIAL, 12 WEEKLY GROUP CLASSES OF SPECIALIZED YOGA ARE LIKELY TO BE A COST-EFFECTIVE INTERVENTION FOR TREATING PATIENTS WITH CHRONIC OR RECURRENT LOW BACK PAIN.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
8  131  34 A PRAGMATIC MULTI-CENTRED RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: TRIAL PROTOCOL. UNLABELLED: A SYSTEMATIC REVIEW REVEALED THREE SMALL RANDOMISED CONTROLLED TRIALS OF YOGA FOR LOW BACK PAIN, ALL OF WHICH SHOWED EFFECTS ON BACK PAIN THAT FAVOURED THE YOGA GROUP. TO BUILD ON THESE STUDIES A LARGER TRIAL, WITH LONGER TERM FOLLOW-UP, AND A NUMBER OF DIFFERENT YOGA TEACHERS DELIVERING THE INTERVENTION IS REQUIRED. THIS STUDY PROTOCOL DESCRIBES THE DETAILS OF A RANDOMISED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN, WHICH IS FUNDED BY ARTHRITIS RESEARCH CAMPAIGN (ARC) AND IS BEING CONDUCTED BY THE UNIVERSITY OF YORK. 262 PATIENTS WILL BE RECRUITED FROM GP PRACTICES IN 5 CENTRES IN ENGLAND. PATIENTS WILL BE RANDOMISED TO RECEIVE USUAL CARE OR 12 WEEKLY CLASSES OF YOGA. A YOGA PROGRAMME WILL BE DEVISED THAT CAN BE DELIVERED BY YOGA TEACHERS OF THE TWO MAIN NATIONAL YOGA ORGANISATIONS IN THE UK (BRITISH WHEEL OF YOGA AND IYENGAR YOGA ASSOCIATION (UK)). TRIAL REGISTRATION: CURRENT CONTROLLED TRIALS REGISTRY ISRCTN81079604 (DATE REGISTERED 30/03/2007).	2010	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
9 1370  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
10 2858  41 YOGA-BASED CARDIAC REHABILITATION: CURRENT PERSPECTIVES FROM RANDOMIZED CONTROLLED TRIALS IN CORONARY ARTERY DISEASE. CORONARY ARTERY DISEASE CARRIES A HIGH MORBIDITY AND MORTALITY WORLDWIDE, AND EXERCISE-BASED CARDIAC REHABILITATION PROGRAMMES PLAY A LARGE ROLE IN SECONDARY PREVENTION. EXERCISE-BASED REHABILITATION PROGRAMMES ARE EXPENSIVE, AND IN CERTAIN SUBGROUPS UPTAKE IS POOR. YOGA HAS BEEN SUGGESTED TO SHOW IMPROVEMENTS IN CARDIOVASCULAR HEALTH WHICH WOULD SUPPORT ITS USE IN CARDIAC REHABILITATION PROGRAMMES. WE CARRIED OUT A REVIEW OF CURRENT RANDOMIZED CONTROLLED TRIALS TO DETERMINE IF YOGA-BASED CARDIAC REHABILITATION LEADS TO REDUCED CARDIAC RISK FACTORS, AND IMPROVED PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES IN PATIENTS WITH CORONARY ARTERY DISEASE COMPARED TO STANDARD CARE. SIX RANDOMIZED CONTROLLED STUDIES WERE IDENTIFIED AFTER A MEDICAL DATABASE SEARCH, AND META-ANALYSIS WAS CARRIED OUT FOR THE DIFFERENT OUTCOMES. OVERALL, THE ADDITION OF YOGA TO STANDARD CARE RESULTED IN IMPROVED SUBJECTIVE FEELING OF CARDIAC HEALTH AND QUALITY OF LIFE. THERE WAS ALSO A TREND TOWARDS IMPROVEMENT IN LEFT VENTRICULAR SYSTOLIC FUNCTION. IMPROVEMENT IN CARDIAC RISK FACTORS, MACE AND PSYCHOLOGICAL HEALTH IN THIS COHORT HAS STILL TO BE PROVEN, BUT WAS NOT INFERIOR TO STANDARD OR ENHANCED CARE, AND THE BENEFITS BECAME MORE PRONOUNCED AT LONGER FOLLOW-UP. FUTURE STUDIES WITH LONGER FOLLOW-UP AND LARGER PATIENT NUMBERS WOULD AID IN ACCURATELY ASSESSING THE LONG-TERM BENEFIT OF YOGA-BASED REHABILITATION.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
11 1854  49 RANDOMISED CONTROLLED TRIAL OF A 12 WEEK YOGA INTERVENTION ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-CARDIAC REHABILITATION PATIENTS. BACKGROUND: NEGATIVE AFFECTIVE STATES SUCH AS ANXIETY, DEPRESSION AND STRESS ARE SIGNIFICANT RISK FACTORS FOR CARDIOVASCULAR DISEASE, PARTICULARLY IN CARDIAC AND POST-CARDIAC REHABILITATION POPULATIONS.YOGA IS A BALANCED PRACTICE OF PHYSICAL EXERCISE, BREATHING CONTROL AND MEDITATION THAT CAN REDUCE PSYCHOSOCIAL SYMPTOMS AS WELL AS IMPROVE CARDIOVASCULAR AND COGNITIVE FUNCTION. IT HAS THE POTENTIAL TO POSITIVELY AFFECT MULTIPLE DISEASE PATHWAYS AND MAY PROVE TO BE A PRACTICAL ADJUNCT TO CARDIAC REHABILITATION IN FURTHER REDUCING CARDIAC RISK FACTORS AS WELL AS IMPROVING SELF-EFFICACY AND POST-CARDIAC REHABILITATION ADHERENCE TO HEALTHY LIFESTYLE BEHAVIOURS. METHOD AND DESIGN: THIS IS A PARALLEL ARM, MULTI-CENTRE, RANDOMISED CONTROLLED TRIAL THAT WILL ASSESS THE OUTCOMES OF POST- PHASE 2 CARDIAC REHABILITATION PATIENTS ASSIGNED TO A YOGA INTERVENTION IN COMPARISON TO A NO-TREATMENT WAIT-LIST CONTROL GROUP. PARTICIPANTS RANDOMISED TO THE YOGA GROUP WILL ENGAGE IN A 12 WEEK YOGA PROGRAM COMPRISING OF TWO GROUP BASED SESSIONS AND ONE SELF-ADMINISTERED HOME SESSION EACH WEEK. GROUP BASED SESSIONS WILL BE LED BY AN EXPERIENCED YOGA INSTRUCTOR. THIS WILL INVOLVE TEACHING BEGINNER STUDENTS A HATHA YOGA SEQUENCE THAT INCORPORATES ASANA (POSES AND POSTURES), PRANAYAMA (BREATHING CONTROL) AND MEDITATION. THE PRIMARY OUTCOMES OF THIS STUDY ARE NEGATIVE AFFECTIVE STATES OF ANXIETY, DEPRESSION AND STRESS ASSESSED USING THE DEPRESSION ANXIETY STRESS SCALE. SECONDARY OUTCOMES INCLUDE MEASURES OF QUALITY OF LIFE, AND CARDIOVASCULAR AND COGNITIVE FUNCTION. THE CARDIOVASCULAR OUTCOMES WILL INCLUDE BLOOD PRESSURE, HEART RATE, HEART RATE VARIABILITY, PULSE WAVE VELOCITY, CAROTID INTIMA MEDIA THICKNESS MEASUREMENTS, LIPID/GLUCOSE PROFILES AND C-REACTIVE PROTEIN ASSAYS. ASSESSMENTS WILL BE CONDUCTED PRIOR TO (WEEK 0), MID-WAY THROUGH (WEEK 6) AND FOLLOWING THE INTERVENTION PERIOD (WEEK 12) AS WELL AS AT A FOUR WEEK FOLLOW-UP (WEEK 16). DISCUSSION: THIS STUDY WILL DETERMINE THE EFFECT OF YOGA PRACTICE ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-PHASE 2 CARDIAC REHABILITATION PATIENTS. THE FINDINGS MAY PROVIDE EVIDENCE TO INCORPORATE YOGA INTO STANDARDISED CARDIAC REHABILITATION PROGRAMS AS A PRACTICAL ADJUNCT TO IMPROVE THE MANAGEMENT OF PSYCHOSOCIAL SYMPTOMS ASSOCIATED WITH CARDIOVASCULAR EVENTS IN ADDITION TO IMPROVING PATIENTS' COGNITIVE AND CARDIOVASCULAR FUNCTIONS. TRIAL REGISTRATION: ACTRN12612000358842.	2014	
                                                                                                                 
12 1591  42 MEDITATION AND YOGA FOR IRRITABLE BOWEL SYNDROME: STUDY PROTOCOL FOR A RANDOMISED CLINICAL TRIAL (MY-IBS STUDY). INTRODUCTION: WHEN DELIVERED IN PERSON, YOGA HAS BEEN SHOWN TO BE EFFECTIVE IN MANAGING IRRITABLE BOWEL SYNDROME (IBS) SYMPTOMS. RESEARCH IS NEEDED TO TEST THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC OPTION WHEN DELIVERED VIRTUALLY. THE PRIMARY AIM OF THE MIND AND YOGA FOR IBS RANDOMISED CONTROLLED TRIAL IS TO DETERMINE THE EFFECTS OF AN 8-WEEK VIRTUAL MEDITATION AND YOGA INTERVENTION ON IBS SYMPTOM SEVERITY COMPARED WITH AN ADVICE-ONLY ACTIVE CONTROL GROUP. METHODS AND ANALYSIS: ADULTS DIAGNOSED WITH IBS WILL BE RANDOMISED TO RECEIVE EITHER A UPA YOGA INTERVENTION OR AN ADVICE-ONLY CONTROL GROUP. THE INTERVENTION WILL CONSIST OF WEEKLY ONLINE CLASSES FOR 8 WEEKS DELIVERED BY A FACILITATOR USING MICROSOFT OFFICE TEAMS AND DAILY HOME PRACTICE. FEASIBILITY WILL BE EVALUATED BY EXAMINING RECRUITMENT AND ATTRITION RATES, ADHERENCE, PARTICIPANT SATISFACTION WITH THE PROGRAMME AND SAFETY. THE PRIMARY OUTCOME IS IBS SYMPTOM SEVERITY, AND KEY SECONDARY OUTCOMES INCLUDE (BUT NOT LIMITED TO) QUALITY OF LIFE, ANXIETY AND DEPRESSION SYMPTOMS, COVID-19-RELATED STRESS AND ANXIETY, AND FATIGUE. OUTCOMES WILL BE ASSESSED AT BASELINE, 4 WEEKS AND 8 WEEKS. AN EMBEDDED DESIGN EXPERIMENTAL MODEL SUBSTUDY WILL BE CONDUCTED POST INTERVENTION USING QUALITATIVE RESEARCH METHODS TO IDENTIFY PARTICIPANTS' EXPERIENCES IN THE YOGA PROGRAMME. ETHICS AND DISSEMINATION: THIS STUDY HAS BEEN APPROVED BY THE CONJOINT HEALTH RESEARCH ETHICS BOARD (REB ID 20-0084). FINDINGS WILL BE DISSEMINATED THROUGH PEER-REVIEWED PUBLICATION, CONFERENCE PRESENTATION AND SOCIAL MEDIA. TRIAL REGISTRATION NUMBER: NCT04302623.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
13 2764  53 YOGA PROGRAMME FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH RISK PEOPLE IN INDIA: A MULTICENTRE FEASIBILITY RANDOMISED CONTROLLED TRIAL PROTOCOL. INTRODUCTION: A HUGE POPULATION IN INDIA IS AT HIGH RISK OF TYPE-2 DIABETES (T2DM). PHYSICAL ACTIVITY AND A HEALTHY DIET (HEALTHY LIFESTYLE) IMPROVE BLOOD GLUCOSE LEVELS IN PEOPLE AT HIGH RISK OF T2DM. HOWEVER, AN UNHEALTHY LIFESTYLE IS COMMON AMONG INDIANS. YOGA COVERS PHYSICAL ACTIVITY AND A HEALTHY DIET AND CAN HELP TO PREVENT T2DM. THE RESEARCH QUESTION TO BE ADDRESSED BY THE MAIN RANDOMISED CONTROLLED TRIAL (RCT) IS WHETHER A YOGA PROGRAMME FOR T2DM PREVENTION (YOGA-DP) IS EFFECTIVE IN PREVENTING T2DM AMONG HIGH RISK PEOPLE IN INDIA AS COMPARED WITH ENHANCED STANDARD CARE. IN THIS CURRENT STUDY, WE ARE DETERMINING THE FEASIBILITY OF UNDERTAKING THE MAIN RCT. INTERVENTION: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAMME. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES) AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. METHODS AND ANALYSIS: THIS IS A MULTICENTRE, TWO-ARM, PARALLEL-GROUP, FEASIBILITY RCT WITH BLINDED OUTCOME ASSESSMENT AND INTEGRATED MIXED-METHODS PROCESS EVALUATION. ELIGIBLE PARTICIPANTS SHOULD BE AGED 18-74 YEARS, AT HIGH RISK OF T2DM (FASTING PLASMA GLUCOSE LEVEL 5.6-6.9 MMOL/L) AND SAFE TO PARTICIPATE IN PHYSICAL ACTIVITIES. AT LEAST 64 PARTICIPANTS WILL BE RANDOMISED TO INTERVENTION OR CONTROL GROUP WITH FINAL FOLLOW-UP AT 6 MONTHS. IMPORTANT PARAMETERS, NEEDED TO DESIGN THE MAIN RCT, WILL BE ESTIMATED, SUCH AS SD OF THE OUTCOME MEASURE (FASTING PLASMA GLUCOSE LEVEL AT 6-MONTH FOLLOW-UP), RECRUITMENT, INTERVENTION ADHERENCE, FOLLOW-UP, POTENTIAL CONTAMINATION AND TIME NEEDED TO CONDUCT THE STUDY. SEMISTRUCTURED QUALITATIVE INTERVIEWS WILL BE CONDUCTED WITH UP TO 20-30 PARTICIPANTS, A SAMPLE OF THOSE DECLINING TO PARTICIPATE, FOUR YOGA-DP INSTRUCTORS AND AROUND EIGHT STUDY STAFF TO EXPLORE THEIR PERCEPTIONS AND EXPERIENCES OF TAKING PART IN THE STUDY AND OF THE INTERVENTION, REASONS BEHIND NON-PARTICIPATION, EXPERIENCES OF DELIVERING THE INTERVENTION AND RUNNING THE STUDY, RESPECTIVELY. ETHICS AND DISSEMINATION: ETHICS APPROVAL HAS BEEN OBTAINED FROM THE FOLLOWING RESEARCH ETHICS COMMITTEES: FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITY OF NOTTINGHAM (UK); CENTRE FOR CHRONIC DISEASE CONTROL (CCDC, INDIA); BAPU NATURE CURE HOSPITAL AND YOGASHRAM (BNCHY, INDIA) AND SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA (S-VYASA, INDIA). THE RESULTS WILL BE WIDELY DISSEMINATED AMONG KEY STAKEHOLDERS THROUGH VARIOUS AVENUES. TRIAL REGISTRATION NUMBER: CTRI/2019/05/018893.	2020	

14 2394  39 YOGA AND BREATHING TECHNIQUE TRAINING IN PATIENTS WITH HEART FAILURE AND PRESERVED EJECTION FRACTION: STUDY PROTOCOL FOR A RANDOMIZED CLINICAL TRIAL. BACKGROUND: CURRENT THERAPIES FOR HEART FAILURE (HF) ARE FOLLOWED BY STRATEGIES TO IMPROVE QUALITY OF LIFE AND EXERCISE TOLERANCE, BESIDES REDUCING MORBIDITY AND MORTALITY. SOME HF PATIENTS PRESENT CHANGES IN THE MUSCULOSKELETAL SYSTEM AND INSPIRATORY MUSCLE WEAKNESS, WHICH MAY BE RESTORED BY INSPIRATORY MUSCLE TRAINING, THUS INCREASING RESPIRATORY MUSCLE STRENGTH AND ENDURANCE, MAXIMAL OXYGEN UPTAKE (VO2), FUNCTIONAL CAPACITY, RESPIRATORY RESPONSES TO EXERCISE, AND QUALITY OF LIFE. YOGA THERAPIES HAVE BEEN SHOWN TO IMPROVE QUALITY OF LIFE, INFLAMMATORY MARKERS, AND PEAK VO2 MOSTLY IN HF PATIENTS WITH A REDUCED EJECTION FRACTION. HOWEVER, THE EFFECT OF DIFFERENT YOGA BREATHING TECHNIQUES IN PATIENTS SHOWING HF WITH A PRESERVED EJECTION FRACTION (HFPEF) REMAIN TO BE ASSESSED. METHODS/DESIGN: A PROBE (PROSPECTIVE RANDOMIZED OPEN BLINDED END-POINT) PARALLEL-GROUP TRIAL WILL BE CONDUCTED AT TWO SPECIALIZED HF CLINICS. ADULT PATIENTS PREVIOUSLY DIAGNOSED WITH HFPEF WILL BE INCLUDED. AFTER SIGNING INFORMED CONSENT AND PERFORMING A PRE-TEST INTERVENTION, PATIENTS WILL BE RANDOMIZED INTO THREE GROUPS AND PROVIDED WITH EITHER (1) ACTIVE YOGA BREATHING TECHNIQUES; (2) PASSIVE YOGA BREATHING TECHNIQUES (PRANAYAMA); OR AND (3) CONTROL (STANDARD PHARMACOLOGICAL TREATMENT). FOLLOW-UP WILL LAST 8 WEEKS (16 SESSIONS). THE POST-INTERVENTION TESTS WILL BE PERFORMED AT THE END OF THE INTERVENTION PERIOD FOR ANALYSIS OF OUTCOMES. INTERVENTIONS WILL OCCUR CONTINUOUSLY ACCORDING TO PATIENTS' ENROLLMENT. THE MAIN OUTCOME IS RESPIRATORY MUSCULAR RESISTANCE. A TOTAL OF 33 ENROLLED PATIENTS ARE EXPECTED. THE PRESENT PROTOCOL FOLLOWED THE SPIRIT GUIDELINES AND FULFILLED THE SPIRIT CHECKLIST. DISCUSSION: THIS TRIAL IS PROBABLY THE FIRST TO ASSESS THE EFFECTS OF A NON-PHARMACOLOGICAL INTERVENTION, NAMELY YOGA AND SPECIFIC BREATHING TECHNIQUES, TO IMPROVE CARDIORESPIRATORY FUNCTION, AUTONOMIC SYSTEM, AND QUALITY OF LIFE IN PATIENTS WITH HFPEF. TRIAL REGISTRATION: REBEC IDENTIFIER: RBR-64MBNX (AUGUST 19, 2012). CLINICAL TRIALS REGISTER: NCT03028168 . REGISTERED ON 16 JANUARY 2017).	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
15 2036  41 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	
                                                                                                                                                                                                                                                                                                                                                       
16  279  37 ADHERENCE AND RETENTION OF AFRICAN AMERICANS IN A RANDOMIZED CONTROLLED TRIAL WITH A YOGA-BASED INTERVENTION: THE EFFECTS OF HEALTH PROMOTING PROGRAMS ON CARDIOVASCULAR DISEASE RISK STUDY. OBJECTIVES: SEDENTARY LIFESTYLE IS A RISK FACTOR FOR CARDIOVASCULAR DISEASE (CVD). FEW ALTERNATIVE LIFESTYLE INTERVENTIONS, SUCH AS YOGA PRACTICE, FOCUS ON AFRICAN AMERICANS (AA), THE POPULATION MOST VULNERABLE TO CVD. OUR OBJECTIVE IS TO COMPARE THE RETENTION AND ADHERENCE RATES BETWEEN YOGA, WALKING, AND HEALTH EDUCATION INTERVENTIONS WHILE PROVIDING INFORMATION ABOUT THE ACCEPTANCE OF VARIOUS YOGA REGIMENS. DESIGN: THREE HUNDRED SEVENTY-FIVE AA PARTICIPANTS WERE RECRUITED EXCLUSIVELY FROM AN ACTIVE COHORT STUDY AND RANDOMIZED INTO A 48-WEEK STUDY (24 WEEKS INTERVENTION, 24 WEEKS FOLLOW-UP) WITH 5 HEALTH PROMOTION INTERVENTIONS: HIGH FREQUENCY YOGA, MODERATE FREQUENCY YOGA, LOW FREQUENCY YOGA, GUIDED WALKING, AND HEALTH EDUCATION. IN ADDITION TO EXAMINING THE SEPARATE YOGA INTERVENTIONS, A POOLED YOGA INTERVENTION IS CONSIDERED FOR COMPARISON TO GUIDED WALKING AND HEALTH EDUCATION. PARTICIPANT RETENTION, ADHERENCE, AND VITALS WERE MONITORED AT EACH INTERVENTION SESSION. PARTICIPANTS WERE ALSO SCHEDULED FOR FOUR CLINIC VISITS THROUGHOUT THE STUDY WHERE BLOOD PANELS, HEALTH BEHAVIOR, AND MEDICATION SURVEYS WERE ADMINISTERED. RESULTS: OF THE 375 PARTICIPANTS RECRUITED, 31.7% DID NOT COMPLETE THE STUDY. AT BASELINE, IN BOTH THE GUIDED WALKING GROUP AND THE HIGH FREQUENCY YOGA GROUP, THERE WERE SIGNIFICANT DIFFERENCES BETWEEN THOSE WHO COMPLETED THE STUDY AND THOSE WHO DID NOT. ALTHOUGH INTERVENTION RETENTION IN THE POOLED YOGA PROGRAM (78.3%) WAS HIGHER COMPARED TO THE WALKING (60%) AND EDUCATION PROGRAMS (74.3%) (P = 0.007), DIFFERENCES IN POST-INTERVENTION RETENTION WAS NOT SIGNIFICANT. MEDIAN ADHERENCE RATES FOR THE POOLED YOGA PROGRAM EXCEEDED RATES FOR GUIDED WALKING AND EDUCATION WITH MODERATE FREQUENCY YOGA OUT PERFORMING HIGH AND LOW FREQUENCY YOGA. CONCLUSION: STUDY-DEFINED RETENTION SUCCESS RATES WERE NOT REACHED BY ALL HEALTH PROMOTION PROGRAMS. HOWEVER, RETENTION AND ADHERENCE RATES FOR THE POOLED YOGA PROGRAM SHOW THAT OLDER AFRICAN AMERICANS ARE RECEPTIVE TO PARTICIPATING IN YOGA-BASED HEALTH PROMOTION PRACTICES.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
17 2579  36 YOGA FOR HEALTH-RELATED QUALITY OF LIFE IN ADULT CANCER: A RANDOMIZED CONTROLLED FEASIBILITY STUDY. AN INCREASE IN PATIENT-LED UPTAKE OF COMPLEMENTARY THERAPIES IN ADULT CANCER HAS LED TO A NEED FOR MORE RIGOROUS STUDY OF SUCH INTERVENTIONS AND THEIR OUTCOMES. THIS STUDY THEREFORE AIMED TO EVALUATE THE FEASIBILITY AND ACCEPTABILITY OF A YOGA INTERVENTION IN MEN AND WOMEN RECEIVING CONVENTIONAL TREATMENT FOR A CANCER DIAGNOSIS. PROSPECTIVE, MIXED METHODS FEASIBILITY TRIAL ALLOCATED PARTICIPANTS TO RECEIVE ONE OF THREE YOGA INTERVENTIONS OVER A FOUR-WEEK STUDY PERIOD. DATA COLLECTION WAS COMPLETED THROUGH ONLINE SURVEY OF QOL-CA/CS AND CUSTOMIZED SURVEYS. FIFTEEN PARTICIPANTS WERE INCLUDED (11 FEMALE) UNDERGOING TREATMENT FOR BREAST, PROSTATE, COLORECTAL, BRAIN, AND BLOOD AND LUNG CANCER. TWO PARTICIPANTS DROPPED OUT AND COMPLETE QUALITATIVE AND QUANTITATIVE DATA SETS WERE COLLECTED FROM 12 PARTICIPANTS AND FOUR YOGA INSTRUCTORS. OTHER OUTCOME MEASURES INCLUDED IMPLEMENTATION COSTS PATIENT-REPORTED PREFERENCES FOR YOGA INTERVENTION AND CHANGES IN QOL-CA/CS. THREE TYPES OF YOGA INTERVENTION WERE SAFELY ADMINISTERED IN ADULT CANCER. MIXED METHODS, COST-EFFICIENCY, QOL-CA/CS, AND EVIDENCE-BASED DESIGN OF YOGA INTERVENTION HAVE BEEN USED TO ESTABLISH FEASIBILITY AND PATIENT-PREFERENCES FOR YOGA DELIVERY IN ADULT CANER. RESULTS SUGGEST THAT, WITH SOME METHODOLOGICAL IMPROVEMENTS, A LARGE-SCALE RANDOMIZED CONTROLLED TRIAL IS WARRANTED TO TEST THE EFFICACY OF YOGA FOR MALE AND FEMALE CANCER PATIENTS. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT02309112.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
18  556  32 COST-EFFECTIVENESS OF EARLY INTERVENTIONS FOR NON-SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROLLED STUDY INVESTIGATING MEDICAL YOGA, EXERCISE THERAPY AND SELF-CARE ADVICE. OBJECTIVE: TO EVALUATE THE COST-EFFECTIVENESS OF MEDICAL YOGA AS AN EARLY INTERVENTION COMPARED WITH EVIDENCE-BASED EXERCISE THERAPY AND SELF-CARE ADVICE FOR NON-SPECIFIC LOW BACK PAIN. DESIGN: RANDOMIZED CONTROLLED TRIAL WITH A COST-EFFECTIVENESS ANALYSIS. SUBJECTS: A TOTAL OF 159 PARTICIPANTS RANDOMIZED INTO THE MEDICAL YOGA GROUP (N = 52), THE EXERCISE THERAPY GROUP (N = 52) AND THE SELF-CARE ADVICE GROUP (N = 55). METHODS: THE HEALTH OUTCOME MEASURE EQ-5D WAS APPLIED TO MEASURE QUALITY OF LIFE DATA COMBINED WITH COST DATA COLLECTED FROM TREATMENT GROUPS FROM BASELINE TO 12 MONTHS FOLLOW-UP. OUTCOME MEASURE WAS HEALTH-RELATED QUALITY OF LIFE (HRQL). INCREMENTAL COST PER QUALITY ADJUSTED LIFE YEAR (QALY) WAS ALSO CALCULATED. COST-EFFECTIVENESS ANALYSIS WAS CONDUCTED PRIMARILY FROM THE SOCIETAL AND EMPLOYER PERSPECTIVES. RESULTS: MEDICAL YOGA IS COST-EFFECTIVE COMPARED WITH SELF-CARE ADVICE IF AN EMPLOYER CONSIDERS THE SIGNIFICANT IMPROVEMENT IN THE HRQL OF AN EMPLOYEE WITH LOW BACK PAIN JUSTIFIES THE ADDITIONAL COST OF TREATMENT (I.E. IN THIS STUDY EUR 150). FROM A SOCIETAL PERSPECTIVE, MEDICAL YOGA IS A COST-EFFECTIVE TREATMENT COMPARED WITH EXERCISE THERAPY AND SELF-CARE ADVICE IF AN ADDITIONAL QALY IS WORTH EUR 11,500. SENSITIVITY ANALYSIS SUGGESTS THAT MEDICAL YOGA IS MORE COST-EFFECTIVE THAN ITS ALTERNATIVES. CONCLUSION: SIX WEEKS OF UNINTERRUPTED MEDICAL YOGA THERA-PY IS A COST-EFFECTIVE EARLY INTERVENTION FOR NON-SPECIFIC LOW BACK PAIN, WHEN TREATMENT RECOMMENDATIONS ARE ADHERED TO.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
19 2117  42 THE EFFECT OF YOGA ON WOMEN WITH SECONDARY ARM LYMPHOEDEMA FROM BREAST CANCER TREATMENT. BACKGROUND: WOMEN WHO DEVELOP SECONDARY ARM LYMPHOEDEMA SUBSEQUENT TO TREATMENT ASSOCIATED WITH BREAST CANCER REQUIRE LIFE-LONG MANAGEMENT FOR A RANGE OF SYMPTOMS INCLUDING ARM SWELLING, HEAVINESS, TIGHTNESS IN THE ARM AND SOMETIMES THE CHEST, UPPER BODY IMPAIRMENT AND CHANGES TO A RANGE OF PARAMETERS RELATING TO QUALITY OF LIFE. WHILE EXERCISE UNDER CONTROLLED CONDITIONS HAS HAD POSITIVE OUTCOMES, THE IMPACT OF YOGA HAS NOT BEEN INVESTIGATED. THE AIM OF THIS STUDY IS TO DETERMINE THE EFFECTIVENESS OF YOGA IN THE PHYSICAL AND PSYCHO-SOCIAL DOMAINS, IN THE HOPE THAT WOMEN CAN BE OFFERED ANOTHER SAFE, HOLISTIC MODALITY TO HELP CONTROL MANY, IF NOT ALL, OF THE EFFECTS OF SECONDARY ARM LYMPHOEDEMA. METHODS AND DESIGN: A RANDOMISED CONTROLLED PILOT TRIAL WILL BE CONDUCTED IN HOBART AND LAUNCESTON WITH A TOTAL OF 40 WOMEN RECEIVING EITHER YOGA INTERVENTION OR CURRENT BEST PRACTICE CARE. INTERVENTION WILL CONSIST OF EIGHT WEEKS OF A WEEKLY TEACHER-LED YOGA CLASS WITH A HOME-BASED DAILY YOGA PRACTICE DELIVERED BY DVD. PRIMARY OUTCOME MEASURES WILL BE THE EFFECTS OF YOGA ON LYMPHOEDEMA AND ITS ASSOCIATED SYMPTOMS AND QUALITY OF LIFE. SECONDARY OUTCOME MEASURES WILL BE RANGE OF MOTION OF THE ARM AND THORACIC SPINE, SHOULDER STRENGTH, AND WEEKLY AND DAILY PHYSICAL ACTIVITY. PRIMARY AND SECONDARY OUTCOMES WILL BE MEASURED AT BASELINE, WEEKS FOUR, EIGHT AND A FOUR WEEK FOLLOW UP AT WEEK TWELVE. RANGE OF MOTION OF THE SPINE, IN A SELF-NOMINATED GROUP, WILL BE MEASURED AT BASELINE, WEEKS EIGHT AND TWELVE. A FURTHER OUTCOME WILL BE THE WOMEN'S PERCEPTIONS OF THE YOGA COLLECTED BY INTERVIEW AT WEEK EIGHT. DISCUSSION: THE RESULTS OF THIS TRIAL WILL PROVIDE INFORMATION ON THE SAFETY AND EFFECTIVENESS OF YOGA FOR WOMEN WITH SECONDARY ARM LYMPHOEDEMA FROM BREAST CANCER TREATMENT. IT WILL ALSO INFORM METHODOLOGY FOR FUTURE, LARGER TRIALS. TRIAL REGISTRATION: ACTRN12611000202965.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
20 2187  43 THE EFFECTS OF YOGA ON STUDENT MENTAL HEALTH: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: UNIVERSITIES AROUND THE WORLD ARE FACING AN EPIDEMIC OF MENTAL DISTRESS AMONG THEIR STUDENTS. THE PROBLEM IS TRULY A PUBLIC HEALTH ISSUE, AFFECTING MANY AND WITH SERIOUS CONSEQUENCES. THE GLOBAL BURDEN OF DISEASE-AGENDA CALLS FOR EFFECTIVE INTERVENTIONS WITH LASTING EFFECTS THAT HAVE THE POTENTIAL TO IMPROVE THE MENTAL HEALTH OF YOUNG ADULTS. IN THIS STUDY WE AIMED TO DETERMINE WHETHER YOGA, A POPULAR AND WIDELY AVAILABLE MIND-BODY PRACTICE, CAN IMPROVE STUDENT MENTAL HEALTH. METHODS: WE PERFORMED A RANDOMISED CONTROLLED TRIAL WITH 202 HEALTHY UNIVERSITY STUDENTS IN THE OSLO AREA. THE PARTICIPANTS WERE ASSIGNED TO A YOGA GROUP OR WAITLIST CONTROL GROUP IN A 1:1 RATIO BY A SIMPLE ONLINE RANDOMISATION PROGRAM. THE INTERVENTION GROUP WAS OFFERED 24 YOGA SESSIONS OVER 12 WEEKS. MEASUREMENTS WERE TAKEN AT WEEK 0 (BASELINE), WEEK 12 (POST-INTERVENTION), AND WEEK 24 (FOLLOW-UP). THE PRIMARY OUTCOME WAS PSYCHOLOGICAL DISTRESS ASSESSED BY THE HSCL-25 QUESTIONNAIRE. ANALYSIS WAS PERFORMED BASED ON THE INTENTION TO TREAT-PRINCIPLE. RESULTS: BETWEEN 24 JANUARY 2017, AND 27 AUGUST 2017, WE RANDOMLY ASSIGNED 202 STUDENTS TO A YOGA INTERVENTION GROUP (N = 100), OR WAITLIST CONTROL GROUP (N = 102). COMPARED WITH THE CONTROL GROUP, THE YOGA PARTICIPANTS DEMONSTRATED A SIGNIFICANT REDUCTION IN DISTRESS SYMPTOMS BOTH AT POST-INTERVENTION (ADJUSTED DIFFERENCE IN THE MEAN CHANGE -0.15, 95% CI -0.26 TO -0.03, P = 0.0110) AND FOLLOW-UP (ADJUSTED DIFFERENCE IN THE MEAN CHANGE -0.18, 95% CI -0.29 TO -0.06, P = 0.0025). SLEEP QUALITY ALSO IMPROVED AT POST-INTERVENTION AND FOLLOW-UP. NO ADVERSE EVENTS WERE REPORTED. CONCLUSIONS: OUR FINDINGS SUGGEST THAT YOGA HAS A MODERATELY LARGE AND LASTING EFFECT, AT LEAST FOR SOME MONTHS, REDUCING SYMPTOMS OF DISTRESS AND IMPROVING SLEEP QUALITY AMONG STUDENTS. FURTHER RESEARCH SHOULD SEEK WAYS TO ENHANCE THE EFFECT, ASSESS AN EVEN LONGER FOLLOW-UP PERIOD, INCLUDE ACTIVE CONTROL GROUPS, AND CONSIDER PERFORMING SIMILAR STUDIES IN OTHER CULTURAL SETTINGS.TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT04258540.	2020