1 1591 142 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
2 1161  50 EVALUATING A GROUP-BASED YOGA OF STRESS RESILIENCE PROGRAMME: A PRAGMATIC BEFORE-AFTER INTERVENTIONAL STUDY PROTOCOL. INTRODUCTION: RATES OF MENTAL HEALTH ILLNESSES AND BURNOUT ARE INCREASING INTERNATIONALLY. THERAPEUTIC YOGA IS INCREASINGLY USED TO IMPROVE AND MAINTAIN PHYSICAL, MENTAL AND EMOTIONAL WELL-BEING AND GENERAL HEALTH. THIS PROTOCOL DESCRIBES A STUDY TO EVALUATE THE EFFECTIVENESS OF AN EXISTING PRIMARY CARE GROUP-BASED THERAPEUTIC YOGA PROGRAMME, THE YOGA OF STRESS RESILIENCE PROGRAMME, WHICH COMBINES YOGA AND PSYCHOTHERAPEUTIC TECHNIQUES, IN IMPROVING MENTAL HEALTH AND DECREASING BURNOUT. IMPLEMENTATION FACTORS WILL ALSO BE EVALUATED FOR POTENTIAL SCALE-UP. METHODS AND ANALYSIS: A PRAGMATIC BEFORE-AFTER INTERVENTIONAL TRIAL DESIGN WILL BE USED TO STUDY CHANGES IN OCCUPATIONAL PARTICIPATION AND MENTAL HEALTH OUTCOMES, INCLUDING ANXIETY, DEPRESSION, BURNOUT, FUNCTIONAL IMPAIRMENT, INSOMNIA, PERCEIVED STRESS, LONELINESS, SELF-COMPASSION AND READINESS FOR CHANGE IN ADULTS EXPERIENCING ANXIETY AND BURNOUT. REPEATED MEASURES ANALYSIS OF VARIANCE WILL BE USED TO DETERMINE CHANGES IN OUTCOME MEASURES OVER TIME. REGRESSION AND MULTIVARIATE ANALYSES WILL BE CONDUCTED TO EXAMINE RELATIONSHIPS BETWEEN PARTICIPANT CHARACTERISTICS AND OUTCOMES AND AMONG VARIOUS OUTCOMES. THE REACH, EFFECTIVENESS, ADOPTION, IMPLEMENTATION, AND MAINTENANCE FRAMEWORK WILL BE USED TO GUIDE THE ANALYSES. ETHICS AND DISSEMINATION: APPROVAL FROM THE HAMILTON INTEGRATED RESEARCH ETHICS BOARD HAS BEEN WAIVED: PROJECT NUMBER 7082 (FULL REVIEW WAIVED). INFORMED CONSENT WILL BE OBTAINED PRIOR TO ENROLLING ANY PARTICIPANT INTO THE STUDY. ALL DATA WILL BE KEPT CONFIDENTIAL. PEER-REVIEWED PUBLICATIONS AND PRESENTATIONS WILL TARGET RESEARCHERS AND HEALTH PROFESSIONALS. TRIAL REGISTRATION NUMBER: THE CLINICALTRIALS.GOV REGISTRY (NCT03973216).	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
3 2598  45 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
4 2579  35 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
5 2673  33 YOGA IN PRIMARY HEALTH CARE: A QUASI-EXPERIMENTAL STUDY TO ACCESS THE EFFECTS ON QUALITY OF LIFE AND PSYCHOLOGICAL DISTRESS. BACKGROUND: AND PURPOSE: YOGA IS GROWING IN POPULARITY, BUT ITS BENEFITS AND INTEGRATION INTO PRIMARY CARE REMAIN UNCERTAIN. HERE, WE DETERMINE YOGA EFFECTS ON QUALITY OF LIFE AND PSYCHOLOGICAL DISTRESS, AND EVALUATE THE FEASIBILITY OF INTRODUCING YOGA AT PRIMARY CARE LEVEL. MATERIALS AND METHODS: THIS IS A PROSPECTIVE, LONGITUDINAL, QUASI-EXPERIMENTAL STUDY, WITH AN INTERVENTION (N=49) AND A CONTROL GROUP (N=37). YOGA GROUP UNDERWENT 24-WEEKS PROGRAM OF ONE-HOUR SESSIONS. OUR PRIMARY ENDPOINT WAS QUALITY OF LIFE AND PSYCHOLOGICAL DISTRESS, AS WELL AS SATISFACTION LEVEL AND ADHERENCE RATE. RESULTS: PARTICIPANTS REPORTED A SIGNIFICANT IMPROVEMENT IN ALL DOMAINS OF QUALITY OF LIFE AND A REDUCTION OF PSYCHOLOGICAL DISTRESS. LINEAR REGRESSION ANALYSIS SHOWED THAT YOGA SIGNIFICANTLY IMPROVES PSYCHOLOGICAL QUALITY OF LIFE (P=0.046). CONCLUSION: YOGA IN PRIMARY CARE IS FEASIBLE, SAFE AND HAS A SATISFACTORY ADHERENCE, AS WELL AS A POSITIVE EFFECT ON PSYCHOLOGICAL QUALITY OF LIFE OF PARTICIPANTS.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
6 2613  39 YOGA FOR RISK REDUCTION OF METABOLIC SYNDROME: PATIENT-REPORTED OUTCOMES FROM A RANDOMIZED CONTROLLED PILOT STUDY. LIFESTYLE CHANGE IS RECOMMENDED AS TREATMENT FOR ADULTS AT RISK FOR METABOLIC SYNDROME (METS), ALTHOUGH ADOPTION OF NEW BEHAVIORAL PATTERNS IS LIMITED. IN ADDITION, MOST EXISTING LIFESTYLE INTERVENTIONS DO NOT ADDRESS PSYCHOLOGICAL STRESS OR QUALITY OF LIFE, BOTH OF WHICH IMPACT THE BURDEN OF METS. YOGA, A FORM OF PHYSICAL ACTIVITY THAT INCORPORATES PSYCHOLOGICAL COMPONENTS (E.G., MAINTAINING ATTENTION, RELAXATION), IS A PROMISING INTERVENTION FOR IMPROVING THE BURDEN OF METS. THIS RANDOMIZED CONTROLLED TRIAL ASSESSED THE FEASIBILITY AND PRELIMINARY EFFICACY OF A 12-WEEK YOGA PROGRAM COUPLED WITH AN EVIDENCE-BASED HEALTH EDUCATION PROGRAM (HED) COMPARED TO HED ALONE. A SECONDARY, EXPLORATORY AIM EXAMINED PERCEIVED STRESS, QUALITY OF LIFE, AND RELATED PSYCHOLOGICAL OUTCOMES (MINDFULNESS, PERCEIVED HEALTH COMPETENCE, AND MOOD). SIXTY-SEVEN ADULTS AT RISK FOR METS ENROLLED (MEAN AGE [SD]: 58 [10] YEARS; 50% MALE; 79% NON-HISPANIC WHITE). PRELIMINARY RESULTS REVEALED SIGNIFICANTLY LARGER IMPROVEMENTS IN TWO QUALITY OF LIFE DOMAINS (ROLE-PHYSICAL AND GENERAL HEALTH PERCEPTIONS) IN THE HED PLUS YOGA GROUP VERSUS HED ALONE (PS < 0.05). THIS IS THE FIRST STUDY THAT IMPLEMENTED LIFESTYLE EDUCATION ALONG WITH YOGA TO EVALUATE THE POTENTIAL UNIQUE EFFECTS OF YOGA ON PARTICIPANTS AT RISK FOR METS. A LARGER CLINICAL TRIAL IS WARRANTED TO FURTHER INVESTIGATE THESE PROMISING PATIENT-REPORTED OUTCOMES.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
7 2117  51 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
8  888  57 EFFECT OF YOGA VERSUS LIGHT EXERCISE TO IMPROVE WELL-BEING AND PROMOTE HEALTHY AGING AMONG OLDER ADULTS IN CENTRAL INDIA: A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: AGING IS A NATURAL PROCESS ASSOCIATED WITH MANY FUNCTIONAL AND STRUCTURAL CHANGES. THESE CHANGES MAY INCLUDE IMPAIRED SELF-REGULATION, CHANGES IN TISSUES AND ORGANS. AGING ALSO AFFECTS MOOD, PHYSICAL STATUS AND SOCIAL ACTIVITY. THERE ARE ADVERSE CHANGES IN COGNITIVE BEHAVIOR, PERCEIVED SENSATION AND THINKING PROCESSES. REGULAR PHYSICAL ACTIVITY CAN ALLEVIATE MANY HEALTH PROBLEMS; YET, MANY OLDER ADULTS ARE INACTIVE. YOGA IS ONE OF THE SCIENTIFIC AND POPULAR LIFESTYLE PRACTICE CONSIDERED AS THE INTEGRATION OF MIND, BODY AND SOUL. RESULTS OF PREVIOUS STUDIES REPORTED POSITIVE EFFECTS OF YOGA ON MULTIPLE HEALTH OUTCOMES IN ELDERLY. HOWEVER, THERE IS SCARCITY OF SCIENTIFIC INFORMATION WHERE YOGA'S EFFECT IS EXAMINED ON OVER WELL-BEING AND ON MULTIPLE HEALTH OUTCOMES SIMULTANEOUSLY IN ELDERLY. THIS PROTOCOL DESCRIBES METHODS FOR A 12-WEEK YOGA-BASED INTERVENTION EXPLORING THE EFFECTS OF YOGA ON WELL-BEING IN PHYSICALLY INACTIVE ELDERLY LIVING IN COMMUNITY. METHODS AND ANALYSIS: THIS TWO GROUP PARALLEL SINGLE BLIND RANDOMIZED CONTROLLED TRIAL THAT WILL BE CONDUCTED AT A DESIGNATED FACILITY OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, MADHYA PRADESH, CENTRAL INDIA. A 12-WEEK 60-MIN YOGA INTERVENTION THREE TIMES WEEKLY IS DESIGNED. COMPARISON GROUP PARTICIPANTS WILL UNDERGO A 60-MIN PROGRAM COMPRISING LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING TO IMPROVE MOBILITY. AFTER SCREENING, 144 PARTICIPANTS AGED 60-80 YEARS WILL BE RECRUITED. THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE MOBILITY, FALL RISK, COGNITION, ANXIETY AND DEPRESSION, MOOD AND STRESS, SLEEP QUALITY, PAIN, PHYSICAL ACTIVITY/SEDENTARY BEHAVIOR AND CARDIO-METABOLIC RISK FACTORS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE (0 WEEK), AFTER THE INTERVENTION (12+1 WEEK) AND AT FOLLOW-UP (36+1 WEEK). INTENTION-TO-TREAT ANALYSES WITH MIXED LINEAR MODELING WILL BE APPLIED. DISCUSSION: THROUGH THIS TRIAL, WE AIM TO DETERMINE WHETHER ELDERLY PEOPLE IN THE INTERVENTION GROUP PRACTICING YOGA SHOW MORE FAVORABLE PRIMARY (WELL-BEING) AND SECONDARY OUTCOMES THAN THOSE IN THE LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING GROUP. WE ASSUME THAT YOGA MAY BE PRACTICED TO MAINTAIN HEALTH, REDUCE PARTICULAR SYMPTOMS COMMONLY ASSOCIATED WITH SKELETAL PAIN, ASSIST IN PAIN RELIEF AND ENHANCE WELL-BEING. WE ANTICIPATE THAT PRACTICING YOGA WILL IMPROVE WELL-BEING AND MENTAL HEALTH AND MAY LEAD TO SIGNIFICANT IMPROVEMENT IN DEPRESSION, PAIN AND SLEEP QUALITY.ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, IEC REF NO. 09/2018. ALL PARTICIPANTS WOULD BE PROVIDED WITH WRITTEN AND VERBAL INFORMATION ABOUT THE PURPOSE OF THE PROJECT AND WOULD BE FREE TO WITHDRAW FROM THE STUDY AT ANY TIME. REFUSAL TO PARTICIPATE IN THE STUDY WOULD NOT HAVE ANY NEGATIVE CONSEQUENCES. CONFIDENTIALITY OF THE INFORMATION OF EACH PARTICIPANT WOULD BE ENSURED. KNOWLEDGE OBTAINED WOULD BE DISSEMINATED TO STAKEHOLDERS THROUGH WORKSHOPS, MEETINGS AND RELEVANT SCIENTIFIC CONFERENCES. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE INDIAN COUNCIL OF MEDICAL RESEARCH TRIAL REGISTRY CTRI/2018/07/015051.	2019	

9 2036  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
10  132  41 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
11 2861  56 YOGA-BASED EXERCISE TO PREVENT FALLS IN COMMUNITY-DWELLING PEOPLE AGED 60 YEARS AND OVER: STUDY PROTOCOL FOR THE SUCCESSFUL AGEING (SAGE) YOGA RANDOMISED CONTROLLED TRIAL. INTRODUCTION: FALLS SIGNIFICANTLY REDUCE INDEPENDENCE AND QUALITY OF LIFE IN OLDER AGE. BALANCE-SPECIFIC EXERCISE PREVENTS FALLS IN PEOPLE AGED 60+ YEARS. YOGA IS GROWING IN POPULARITY AND CAN PROVIDE A HIGH CHALLENGE TO BALANCE; HOWEVER, THE EFFECT OF YOGA ON FALLS HAS NOT BEEN EVALUATED. THIS TRIAL AIMS TO ESTABLISH THE EFFECT ON FALLS OF A YOGA EXERCISE PROGRAMME COMPARED WITH A YOGA RELAXATION PROGRAMME IN COMMUNITY-DWELLERS AGED 60+ YEARS. METHOD AND ANALYSIS: THIS RANDOMISED CONTROLLED TRIAL WILL INVOLVE 560 COMMUNITY-DWELLING PEOPLE AGED 60+ YEARS. PARTICIPANTS WILL BE RANDOMISED TO EITHER: (1) THE SUCCESSFUL AGEING (SAGE) YOGA EXERCISE PROGRAMME OR (2) A YOGA RELAXATION PROGRAMME. PRIMARY OUTCOME IS RATE OF FALLS IN THE 12 MONTHS POST RANDOMISATION. SECONDARY OUTCOMES INCLUDE MENTAL WELL-BEING, PHYSICAL ACTIVITY, HEALTH-RELATED QUALITY OF LIFE, BALANCE SELF-CONFIDENCE, PHYSICAL FUNCTION, PAIN, GOAL ATTAINMENT AND SLEEP QUALITY AT 12 MONTHS AFTER RANDOMISATION. THE NUMBER OF FALLS PER PERSON-YEAR WILL BE ANALYSED USING NEGATIVE BINOMIAL REGRESSION MODELS TO ESTIMATE BETWEEN-GROUP DIFFERENCE IN FALL RATES. GENERALISED LINEAR MODELS WILL ASSESS THE EFFECT OF GROUP ALLOCATION ON THE CONTINUOUSLY SCORED SECONDARY OUTCOMES, ADJUSTING FOR BASELINE SCORES. AN ECONOMIC ANALYSIS WILL COMPARE THE COST-EFFECTIVENESS AND COST-UTILITY OF THE TWO YOGA PROGRAMMES. ETHICS AND DISSEMINATION: PROTOCOL WAS APPROVED BY THE HUMAN RESEARCH ETHICS COMMITTEE AT THE UNIVERSITY OF SYDNEY, AUSTRALIA (APPROVAL 2019/604). TRIAL RESULTS WILL BE DISSEMINATED VIA PEER-REVIEWED ARTICLES, CONFERENCE PRESENTATIONS, LAY SUMMARIES. TRIAL REGISTRATION NUMBER: THE PROTOCOL FOR THIS TRIAL IS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY (ACTRN12619001183178).	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
12  175  42 A RANDOMIZED CONTROLLED TRIAL EXAMINING IYENGAR YOGA FOR YOUNG ADULTS WITH RHEUMATOID ARTHRITIS: A STUDY PROTOCOL. BACKGROUND: RHEUMATOID ARTHRITIS IS A CHRONIC, DISABLING DISEASE THAT CAN COMPROMISE MOBILITY, DAILY FUNCTIONING, AND HEALTH-RELATED QUALITY OF LIFE, ESPECIALLY IN OLDER ADOLESCENTS AND YOUNG ADULTS. IN THIS PROJECT, WE WILL COMPARE A STANDARDIZED IYENGAR YOGA PROGRAM FOR YOUNG PEOPLE WITH RHEUMATOID ARTHRITIS TO A STANDARD CARE WAIT-LIST CONTROL CONDITION. METHODS/DESIGN: SEVENTY RHEUMATOID ARTHRITIS PATIENTS AGED 16-35 YEARS WILL BE RANDOMIZED INTO EITHER THE 6-WEEK IYENGAR YOGA PROGRAM (12 - 1.5 HOUR SESSIONS TWICE WEEKLY) OR THE 6-WEEK WAIT-LIST CONTROL CONDITION. A 20% ATTRITION RATE IS ANTICIPATED. THE WAIT-LIST GROUP WILL RECEIVE THE YOGA PROGRAM FOLLOWING COMPLETION OF THE FIRST ARM OF THE STUDY. WE WILL COLLECT DATA QUANTITATIVELY, USING QUESTIONNAIRES AND MARKERS OF DISEASE ACTIVITY, AND QUALITATIVELY USING SEMI-STRUCTURED INTERVIEWS. ASSESSMENTS INCLUDE STANDARDIZED MEASURES OF GENERAL AND ARTHRITIS-SPECIFIC FUNCTION, PAIN, MOOD, AND HEALTH-RELATED QUALITY OF LIFE, AS WELL AS QUALITATIVE INTERVIEWS, BLOOD PRESSURE/RESTING HEART RATE MEASUREMENTS, A MEDICAL EXAM AND THE ASSESSMENT OF PRO-INFLAMMATORY CYTOKINES. DATA WILL BE COLLECTED THREE TIMES: BEFORE TREATMENT, POST-TREATMENT, AND TWO MONTHS FOLLOWING THE TREATMENT. DISCUSSION: RESULTS FROM THIS STUDY WILL PROVIDE CRITICAL DATA ON NON-PHARMACOLOGIC METHODS FOR ENHANCING FUNCTION IN RHEUMATOID ARTHRITIS PATIENTS. IN PARTICULAR, RESULTS WILL SHED LIGHT ON THE FEASIBILITY AND POTENTIAL EFFICACY OF A NOVEL INTERVENTION FOR RHEUMATOID ARTHRITIS SYMPTOMS, PAVING THE WAY FOR A LARGER CLINICAL TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01096823.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
13 2187  49 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
14 1998  42 STRENGTH AND AWARENESS IN ACTION: FEASIBILITY OF A YOGA-BASED INTERVENTION FOR POST-ACUTE MILD TBI HEADACHES AMONG VETERANS. BACKGROUND: MILD TRAUMATIC BRAIN INJURY (MTBI) IS A SIGNATURE INJURY SUSTAINED BY VETERANS DURING RECENT CONFLICTS. FOR SOME, MTBI/CONCUSSION IS ASSOCIATED WITH DISABLING SYMPTOMS, INCLUDING POST-CONCUSSIVE HEADACHES (PCH). HOWEVER, THERE ARE LIMITED EVIDENCE-BASED TREATMENTS FOR PERSISTENT PCH. OBJECTIVE: INVESTIGATORS ASSESSED THE FEASIBILITY OF DESIGN ELEMENTS OF A YOGA-BASED INTERVENTIONAL TRIAL FOR PCH AMONG VETERANS, AS WELL AS THE ACCEPTABILITY OF THE INTERVENTION. METHODS: THIS RANDOMIZED CONTROLLED ACCEPTABILITY AND FEASIBILITY TRIAL WAS IMPLEMENTED USING A WAITLIST-CONTROL DESIGN. DESIGN ELEMENTS OF INTEREST INCLUDED: AN EXERCISE RUN-IN CLASS; RECRUITMENT AND RETENTION STRATEGIES; AND, ECOLOGICAL MOMENTARY ASSESSMENT (EMA) MODALITIES TO TRACK HEADACHES AND YOGA PRACTICE. VETERAN SATISFACTION REGARDING THE INTERVENTION WAS ALSO EVALUATED. A DESCRIPTIVE ANALYSIS WAS CONDUCTED ON CANDIDATE OUTCOMES INCLUDING PCH, POST-CONCUSSIVE SYMPTOMS, PAIN, AND DAILY FUNCTIONING. RESULTS: TWENTY-SEVEN PARTICIPANTS (OUT OF 70 CONSENTED AND ELIGIBLE AFTER STUDY VISIT 1) COMPLETED EACH EVALUATION TIMEPOINT AND REGULARLY ATTENDED YOGA SESSIONS, WITH 89% OF THESE VETERANS REPORTING MODERATE TO HIGH LEVELS OF SATISFACTION WITH THE INTERVENTION AT STUDY COMPLETION. QUALITATIVELY, PARTICIPANTS ENDORSED IMPROVEMENTS IN HEADACHES, CHRONIC PAIN, AND MOOD. FEASIBILITY RESULTS WERE MIXED. INITIAL FEASIBILITY CRITERION REGARDING YOGA ATTENDANCE WAS NOT MET; HOWEVER, MODIFICATIONS, SUCH AS EXPANSION TO AN ADDITIONAL CLINIC SITE AND REDUCTION OF IN-PERSON YOGA SESSIONS WITH INCREASED ENCOURAGEMENT TO USE STUDY-CREATED ONLINE YOGA VIDEOS IMPROVED FEASIBILITY OF THE STUDY DESIGN. PARTICIPANTS MOST FREQUENTLY USED MOBILE AND WEB-BASED EMA MODALITIES TO TRACK YOGA PRACTICE. CONCLUSIONS: ALTHOUGH CHALLENGES WITH FEASIBILITY OF THE STUDY DESIGN ELEMENTS WERE NOTED, RESULTS SUGGESTED ACCEPTABILITY OF THE YOGA-BASED INTERVENTION FOR VETERANS WITH PERSISTENT PCH. ADDITIONAL EXPLORATION REGARDING THE FREQUENCY AND MODALITY OF YOGA DELIVERY (E.G., IN-PERSON, TELEHEALTH) IS WARRANTED. IMPACT: VETERANS FOUND THE YOGA-BASED INTERVENTION ACCEPTABLE, HOWEVER EXPLORATION OF NOVEL MODALITIES OF INTERVENTION DELIVERY WILL LIKELY BE NECESSARY TO ENHANCE THE FEASIBILITY OF INTERVENTION IMPLEMENTATION DURING FUTURE TRIALS.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
15  131  36 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
16 2383  26 YOGA & CANCER INTERVENTIONS: A REVIEW OF THE CLINICAL SIGNIFICANCE OF PATIENT REPORTED OUTCOMES FOR CANCER SURVIVORS. LIMITED RESEARCH SUGGESTS YOGA MAY BE A VIABLE GENTLE PHYSICAL ACTIVITY OPTION WITH A VARIETY OF HEALTH-RELATED QUALITY OF LIFE, PSYCHOSOCIAL AND SYMPTOM MANAGEMENT BENEFITS. THE PURPOSE OF THIS REVIEW WAS TO DETERMINE THE CLINICAL SIGNIFICANCE OF PATIENT-REPORTED OUTCOMES FROM YOGA INTERVENTIONS CONDUCTED WITH CANCER SURVIVORS. A TOTAL OF 25 PUBLISHED YOGA INTERVENTION STUDIES FOR CANCER SURVIVORS FROM 2004-2011 HAD PATIENT-REPORTED OUTCOMES, INCLUDING QUALITY OF LIFE, PSYCHOSOCIAL OR SYMPTOM MEASURES. THIRTEEN OF THESE STUDIES MET THE NECESSARY CRITERIA TO ASSESS CLINICAL SIGNIFICANCE. CLINICAL SIGNIFICANCE FOR EACH OF THE OUTCOMES OF INTEREST WAS EXAMINED BASED ON 1 STANDARD ERROR OF THE MEASUREMENT, 0.5 STANDARD DEVIATION, AND RELATIVE COMPARATIVE EFFECT SIZES AND THEIR RESPECTIVE CONFIDENCE INTERVALS. THIS REVIEW DESCRIBES IN DETAIL THESE PATIENT-REPORTED OUTCOMES, HOW THEY WERE OBTAINED, THEIR RELATIVE CLINICAL SIGNIFICANCE AND IMPLICATIONS FOR BOTH CLINICAL AND RESEARCH SETTINGS. OVERALL, CLINICALLY SIGNIFICANT CHANGES IN PATIENT-REPORTED OUTCOMES SUGGEST THAT YOGA INTERVENTIONS HOLD PROMISE FOR IMPROVING CANCER SURVIVORS' WELL-BEING. THIS RESEARCH OVERVIEW PROVIDES NEW DIRECTIONS FOR EXAMINING HOW CLINICAL SIGNIFICANCE CAN PROVIDE A UNIQUE CONTEXT FOR DESCRIBING CHANGES IN PATIENT-REPORTED OUTCOMES FROM YOGA INTERVENTIONS. RESEARCHERS ARE ENCOURAGED TO EMPLOY INDICES OF CLINICAL SIGNIFICANCE IN THE INTERPRETATION AND DISCUSSION OF RESULTS FROM YOGA STUDIES.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
17 1414  38 IMPLEMENTING YOGA THERAPY ADAPTED FOR OLDER VETERANS WHO ARE CANCER SURVIVORS. OBJECTIVES: THIS GOAL OF THIS PAPER IS TO DESCRIBE THE REACH, APPLICATION, AND EFFECTIVENESS OF AN 8-WEEK YOGA THERAPY PROTOCOL WITH OLDER CANCER SURVIVORS WITHIN A VETERANS HEALTH ADMINISTRATION SETTING. METHODS: TO DOCUMENT THE REACH OF THIS INTERVENTION, RECRUITMENT EFFORTS, ATTENDANCE, AND PRACTICE RATES WERE TRACKED. TO EXPLORE THE APPLICATION OF THE PROTOCOL TO THIS POPULATION, PHYSICAL THERAPY PRE-ASSESSMENT AND OBSERVATIONS BY THE YOGA THERAPIST WERE RECORDED TO ASCERTAIN NECESSARY POSE MODIFICATIONS. EFFECTIVENESS WAS MEASURED THROUGH PRE- AND POST-COURSE STRUCTURED INTERVIEWS, TRACKING SELF-REPORTED SYMPTOMS OF COMBAT-RELATED POSTTRAUMATIC STRESS DISORDER, DEPRESSION, ANXIETY, FATIGUE, INSOMNIA, AND PAIN. RESULTS: REGARDING REACH, 15% OF ELIGIBLE VETERANS (N = 14) ENROLLED, PARTICIPATED IN 3-16 CLASSES (M+/-SD = 11.64+/-3.39), AND PRACTICED AT HOME FOR 0-56 DAYS (M+/-SD = 26.36+/-17.87). PARTICIPANTS WERE PRIMARILY CAUCASIAN (N = 13), MALE (N = 13), RANGED IN AGE FROM 55 TO 78 YEARS (M+/-SD = 65.64+/-5.15), AND HAD MULTIPLE MEDICAL PROBLEMS. DURING APPLICATION, SUBSTANTIAL INDIVIDUALIZED MODIFICATIONS TO THE YOGA THERAPY PROTOCOL WERE NECESSARY. EFFECTIVENESS OF THE INTERVENTION WAS MIXED. DURING POST-COURSE INTERVIEWS, PARTICIPANTS REPORTED A VARIETY OF QUALITATIVE BENEFITS. NOTABLY, THE MAJORITY OF PARTICIPANTS REPORTED THAT BREATHING AND RELAXATION TECHNIQUES WERE THE MOST USEFUL TO LEARN. GROUP COMPARISONS OF MEAN PRE- AND POST-COURSE SCORES ON STANDARDIZED MEASURES SHOWED NO SIGNIFICANT DIFFERENCES. CONCLUSIONS: A MINORITY OF OLDER VETERANS EXPRESS AN INTEREST IN YOGA, BUT THOSE WHO DO HAVE HIGH RATES OF CLASS ATTENDANCE AND HOME PRACTICE. CAREFUL PHYSICAL PRE-ASSESSMENT AND ATTENTIVE THERAPISTS ARE REQUIRED TO UNDERTAKE THE ADAPTATIONS REQUIRED BY PARTICIPANTS WITH MULTIPLE COMORBIDITIES. THE EFFECTIVENESS OF YOGA IN THIS SETTING REQUIRES ADDITIONAL STUDY.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
18 1106  39 EFFECTS OF YOGA, AEROBIC, AND STRETCHING AND TONING EXERCISES ON COGNITION IN ADULT CANCER SURVIVORS: PROTOCOL OF THE STAY FIT PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER SURVIVORS EXPERIENCE COMPROMISED QUALITY OF LIFE DUE TO IMPAIRED COGNITIVE FUNCTION AS A RESULT OF CANCER DIAGNOSIS AND TREATMENT. ALTHOUGH EXERCISE HAS PROVEN TO BE EFFECTIVE IN IMPROVING COGNITIVE FUNCTION ACROSS THE LIFESPAN, INTERVENTIONS COMPREHENSIVELY TESTING THE EFFECTIVENESS FOR CANCER SURVIVORS ARE LIMITED. THE STAY FIT TRIAL IS A THREE-ARMED PILOT RANDOMIZED CONTROLLED TRIAL DESIGNED TO COMPARE THE EFFECTS OF A 12-WEEK YOGA, AEROBIC WALKING, AND STRETCH AND TONE INTERVENTION ON COGNITIVE FUNCTION AMONG ADULT CANCER SURVIVORS. METHODS: THIS PILOT STUDY AIMS TO RECRUIT 75 ADULT CANCER SURVIVORS WHO WILL COMPLETE ASSESSMENTS OF COGNITIVE FUNCTION, CARDIOVASCULAR FITNESS, PHYSICAL ACTIVITY, AND PSYCHOSOCIAL MEASURES AT BASELINE AND AFTER THE 12-WEEK INTERVENTION. THE AIMS OF STAY FIT ARE (1) TO ASSESS THE EFFICACY OF YOGA TO IMPROVE COGNITIVE FUNCTION AMONG CANCER SURVIVORS, COMPARED TO AEROBIC EXERCISE AND AN ACTIVE CONTROL GROUP; (2) TO EXAMINE CHANGES IN CARDIOVASCULAR FITNESS AS A RESULT OF THE INTERVENTIONS; AND (3) TO ASSESS CHANGES IN QUALITY OF LIFE AMONG OUR POPULATION AS A RESULT OF THE EXERCISE INTERVENTIONS. DISCUSSION: THE STAY FIT TRIAL WILL TEST THE EFFECTIVENESS OF YOGA, AEROBIC EXERCISE, AND STRETCHING AND TONING EXERCISES IN IMPROVING COGNITIVE FUNCTION AND FITNESS AMONG ADULT CANCER SURVIVORS. THE RESULTS OF THIS PILOT STUDY WILL ENABLE US TO UNDERSTAND THE MOST EFFECTIVE PHYSICAL ACTIVITY MODALITY TO IMPROVE COGNITIVE FUNCTION IN THIS POPULATION AND POTENTIALLY COMBAT CANCER-RELATED COGNITIVE IMPAIRMENT. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03650322 . REGISTERED ON 28 AUGUST 2018.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
19 1242  45 FEASIBILITY OF A YOGA INTERVENTION TO DECREASE PAIN IN OLDER WOMEN: A RANDOMIZED CONTROLLED PILOT STUDY. BACKGROUND: A SIGNIFICANT PROPORTION OF OLDER WOMEN SUFFER FROM CHRONIC PAIN, WHICH CAN DECREASE QUALITY OF LIFE. THE OBJECTIVE OF THIS PILOT RANDOMIZED STUDY WAS TO EVALUATE THE FEASIBILITY OF A FLOW-RESTORATIVE YOGA INTERVENTION DESIGNED TO DECREASE PAIN AND RELATED OUTCOMES AMONG WOMEN AGED 60 OR OLDER. METHODS: FLOW-RESTORATIVE YOGA CLASSES WERE HELD TWICE WEEKLY FOR 1 HOUR AND LED BY A CERTIFIED YOGA INSTRUCTOR. PARTICIPANTS RANDOMIZED TO THE INTERVENTION GROUP ATTENDED THE YOGA CLASSES FOR 12 WEEKS AND RECEIVED SUPPLEMENTAL MATERIALS FOR AT-HOME PRACTICE. THOSE RANDOMIZED TO THE CONTROL GROUP WERE ASKED TO MAINTAIN THEIR NORMAL DAILY ROUTINE. FEASIBILITY WAS EVALUATED USING RECRUITMENT AND RETENTION RATES, CLASS AND HOME PRACTICE ADHERENCE RATES, AND PARTICIPANT SATISFACTION SURVEYS. OUTCOME MEASURES (SELF-REPORTED PAIN, INFLAMMATORY MARKERS, FUNCTIONAL FITNESS, QUALITY OF LIFE, RESILIENCE, AND SELF-REPORTED PHYSICAL ACTIVITY) WERE ASSESSED AT BASELINE AND POST-INTERVENTION. PAIRED T-TESTS OR WILCOXON SIGNED-RANK TESTS WERE USED TO EXAMINE CHANGES IN OUTCOME MEASURES WITHIN TREATMENT GROUPS. RESULTS: THIRTY-EIGHT PARTICIPANTS WERE RECRUITED AND RANDOMIZED. PARTICIPANTS WERE PRIMARILY WHITE, COLLEGE-EDUCATED, AND HIGHER FUNCTIONING, DESPITE EXPERIENCING VARIOUS FORMS OF CHRONIC PAIN. ATTENDANCE AND RETENTION RATES WERE HIGH (91 AND 97%, RESPECTIVELY) AND THE MAJORITY OF PARTICIPANTS WERE SATISFIED WITH THE YOGA PROGRAM (89%) AND WOULD RECOMMEND IT TO OTHERS (87%). INTERVENTION PARTICIPANTS ALSO EXPERIENCED REDUCTIONS IN PAIN INTERFERENCE AND IMPROVEMENTS IN ENERGY AND SOCIAL FUNCTIONING. CONCLUSIONS: THIS PILOT STUDY PROVIDES ESSENTIAL DATA TO INFORM A FULL SCALE RANDOMIZED TRIAL OF FLOW-RESTORATIVE YOGA FOR OLDER WOMEN WITH CHRONIC PAIN. FUTURE STUDIES SHOULD EMPHASIZE STRATEGIES TO RECRUIT A MORE DIVERSE STUDY POPULATION, PARTICULARLY OLDER WOMEN AT HIGHER RISK OF DISABILITY AND FUNCTIONAL DECLINE. TRIAL REGISTRATION: CLINICALTRIALS.GOV , NCT03790098 . REGISTERED 31 DECEMBER 2018 - RETROSPECTIVELY REGISTERED.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
20 1751  26 PILOT STUDY: USE OF MINDFULNESS, SELF-COMPASSION, AND YOGA PRACTICES WITH LOW-INCOME AND/OR UNINSURED PATIENTS WITH DEPRESSION AND/OR ANXIETY. PURPOSE: THIS PILOT STUDY WAS CONDUCTED TO DETERMINE THE EFFECTIVENESS OF MINDFULNESS PRACTICES, INCLUDING SELF-COMPASSION AND YOGA, ON DEPRESSION AND/OR ANXIETY IN UNINSURED AND/OR LOW-INCOME PATIENTS. DESIGN: THE DESIGN WAS REPEATED MEASURES WITH ONE GROUP. METHOD: PATIENTS RECEIVED 8 WEEKS OF MINDFULNESS TRAINING INCLUDING SELF-COMPASSION AND YOGA. DEPRESSION AND ANXIETY SYMPTOMS, SELF-COMPASSION, AND PSYCHOLOGICAL WELL-BEING WERE MEASURED FOUR TIMES. FINDINGS: INTERVENTIONS WERE EFFECTIVE IN HELPING UNINSURED AND LOW-INCOME PATIENTS REDUCE DEPRESSION AND/OR ANXIETY SYMPTOMS. CONCLUSION: THIS STUDY MAY HAVE IMPLICATIONS FOR A COST-EFFECTIVE TREATMENT FOR THESE DISORDERS. THE FINDINGS FROM THIS STUDY CAN PROVIDE USEFUL INFORMATION TO HEALTH CARE PROVIDERS.	2015