1 2283 202 THE USE OF INTEGRATIVE THERAPY BASED ON YOGA AND AYURVEDA IN THE TREATMENT OF A HIGH-RISK CASE OF COVID-19/SARS-COV-2 WITH MULTIPLE COMORBIDITIES: A CASE REPORT. BACKGROUND: WE REPORT A HIGH-RISK CASE OF A CORONAVIRUS DISEASE 19 (COVID-19)-POSITIVE PATIENT WITH COMORBIDITIES INCLUDING DIABETES MELLITUS (DM), HYPERTENSION (HTN), HYPOTHYROIDISM AND CHRONIC KIDNEY DISEASE (CKD), TREATED SUCCESSFULLY USING AN INTEGRATIVE THERAPY PLAN BASED ON AYURVEDA AND YOGA, ALONG WITH GOVERNMENT-MANDATED COMPULSORY MODERN WESTERN MEDICINE (MWM) TREATMENT. RECENTLY, SOME EVIDENCE HAS BEEN EMERGING ON THE USE OF AYURVEDA FOR TREATMENT OF COVID-19. THE CLASSICAL TEXTS OF AYURVEDIC MEDICINE SUCH AS CHARAKA SAMHITA AND SUSHRUTA SAMHITA CONTAIN DESCRIPTIONS OF PANDEMICS OF SIMILAR PROPORTIONS AND DESCRIBE THEM AS JANAPADODDHVANSA, MEANING THE DESTRUCTION OF COMMUNITIES, ALONG WITH THEIR CAUSES AND TREATMENT. CASE PRESENTATION: THE CASE REPORTED HEREIN IS A 55-YEAR-OLD MAN FROM DELHI, INDIA, WITH CONFIRMED (TESTED) COVID-19, WHO FIRST TOOK MWM FOR 7 DAYS BEFORE SEEKING INTEGRATIVE THERAPY. THE PATIENT HAS COMORBIDITIES INCLUDING DM, HTN, HYPOTHYROIDISM AND CKD AND HAD DEVELOPED SYMPTOMS INCLUDING FEVER (WHICH WAS RESOLVED BY THE TIME INTEGRATIVE THERAPY WAS STARTED), SORE THROAT, DRY COUGH, BODY ACHES, WEAKNESS, BAD TASTE AND SMELL, AND HEAVINESS IN THE ABDOMEN. BASED ON THE PATIENT'S SYMPTOMS AND COMORBIDITIES, A TREATMENT PLAN INCLUDING AYURVEDIC MEDICINES, YOGA PROTOCOL, DIETARY RECOMMENDATIONS AND LIFESTYLE MODIFICATIONS WAS PRESCRIBED BY A REGISTERED AYURVEDA DOCTOR AND A YOGA CONSULTANT. THE PATIENT STARTED EXPERIENCING IMPROVEMENT IN ALL THE SYMPTOMS WITHIN 2 DAYS AFTER STARTING THE TREATMENT; HE REPORTED APPROXIMATELY [FORMULA: SEE TEXT] RELIEF FROM THE SYMPTOMS AFTER 5 DAYS, AND ALMOST COMPLETE RELIEF WITHIN 9 DAYS. ALSO, THE BLOOD SUGAR LEVELS (BOTH FASTING BLOOD SUGAR [FBS] AND POSTPRANDIAL BLOOD SUGAR [PPBS]) EXHIBITED SIGNIFICANT IMPROVEMENT AFTER 5 DAYS, AND DECREASED TO WITHIN THE NORMAL RANGE WITHIN 12 DAYS. BESIDES RELIEF IN SYMPTOMS, THE PATIENT'S REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) TEST DONE ON THE 19TH DAY RETURNED NEGATIVE RESULTS. CONCLUSIONS: INTEGRATIVE THERAPY WAS FOUND TO BE EFFECTIVE IN MITIGATING THE SYMPTOMS OF COVID-19 IN THIS PATIENT WITH MULTIPLE COMORBIDITIES. MOREOVER, A SIGNIFICANT IMPROVEMENT IN BLOOD SUGAR LEVELS (NOT UNDER CONTROL WITH MODERN MEDICINE) WAS ALSO ACHIEVED. INTEGRATIVE THERAPY BASED ON THE CLASSICAL TEXTS OF AYURVEDA AND YOGA MAY OFFER A PROMISING AND SCALABLE TREATMENT OPTION FOR COVID-19 PATIENTS. A CASE SERIES OR A SUITABLY DESIGNED RANDOMIZED CONTROLLED TRIAL IS NEEDED TO ASSESS ITS EFFICACY. 2021 2 2117 39 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 3 614 36 DEVELOPMENT OF A YOGA-BASED CARDIAC REHABILITATION (YOGA-CARE) PROGRAMME FOR SECONDARY PREVENTION OF MYOCARDIAL INFARCTION. CARDIAC REHABILITATION (CR) AFTER MYOCARDIAL INFARCTION IS HIGHLY EFFECTIVE. IT IS UNAVAILABLE IN PUBLIC HOSPITALS IN INDIA DUE TO LIMITED RESOURCES. OUR OBJECTIVE WAS TO DEVELOP A SCALABLE MODEL OF CR FOR INDIA BASED ON YOGA, WHICH COULD ALSO APPEAL TO SOME GROUPS WITH LOW UPTAKE OF CR (E.G., ETHNIC MINORITIES, WOMEN, AND OLDER PEOPLE) GLOBALLY. THE INTERVENTION WAS DEVELOPED USING A STRUCTURED PROCESS. A LITERATURE REVIEW AND CONSULTATIONS WITH YOGA EXPERTS, CR EXPERTS, AND POSTMYOCARDIAL INFARCTION PATIENTS WERE CONDUCTED TO SYSTEMATICALLY IDENTIFY AND SHORTLIST APPROPRIATE YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, MEDITATION AND RELAXATION PRACTICES, AND LIFESTYLE CHANGES, WHICH WERE INCORPORATED INTO A CONVENTIONAL CR FRAMEWORK. THE DRAFT INTERVENTION WAS FURTHER REFINED BASED ON THE FEEDBACK FROM AN INTERNAL STAKEHOLDER GROUP AND AN EXTERNAL PANEL OF INTERNATIONAL EXPERTS, BEFORE BEING PILOTED WITH YOGA INSTRUCTORS AND PATIENTS WITH MYOCARDIAL INFARCTION. A FOUR-PHASE YOGA-BASED CR (YOGA-CARE) PROGRAMME WAS DEVELOPED FOR DELIVERY BY A SINGLE YOGA INSTRUCTOR WITH BASIC TRAINING. THE PROGRAMME CONSISTS OF A TOTAL OF 13 INSTRUCTOR-LED SESSIONS (2 INDIVIDUAL AND 11 GROUP) OVER A 3-MONTH PERIOD. GROUP SESSIONS INCLUDE GUIDED PRACTICE OF YOGA EXERCISES AND POSTURES, BREATHING EXERCISES, AND MEDITATION AND RELAXATION PRACTICES, AND SUPPORT FOR THE LIFESTYLE CHANGE AND COPING THROUGH A MODERATED DISCUSSION. PATIENTS ARE ENCOURAGED TO SELF-PRACTICE DAILY AT HOME AND CONTINUE LONG-TERM WITH THE HELP OF A BOOKLET AND DIGITAL VIDEO DISC (DVD). FAMILY MEMBERS/CARERS ARE ENCOURAGED TO JOIN THROUGHOUT. IN CONCLUSION, A NOVEL YOGA-BASED CR PROGRAMME HAS BEEN DEVELOPED, WHICH PROMISES TO PROVIDE A SCALABLE CR SOLUTION FOR INDIA AND AN ALTERNATIVE CHOICE FOR CR GLOBALLY. IT IS CURRENTLY BEING EVALUATED IN A LARGE MULTICENTRE RANDOMISED CONTROLLED TRIAL ACROSS INDIA. 2019 4 2831 38 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927. 2014 5 258 36 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 6 2821 54 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. BACKGROUND: NON-SPECIFIC LOW BACK PAIN IS A COMMON, POTENTIALLY DISABLING CONDITION USUALLY TREATED WITH SELF-CARE AND NON-PRESCRIPTION MEDICATION. FOR CHRONIC LOW BACK PAIN, CURRENT GUIDELINES STATE THAT EXERCISE THERAPY MAY BE BENEFICIAL. YOGA IS A MIND-BODY EXERCISE SOMETIMES USED FOR NON-SPECIFIC LOW BACK PAIN. OBJECTIVES: TO ASSESS THE EFFECTS OF YOGA FOR TREATING CHRONIC NON-SPECIFIC LOW BACK PAIN, COMPARED TO NO SPECIFIC TREATMENT, A MINIMAL INTERVENTION (E.G. EDUCATION), OR ANOTHER ACTIVE TREATMENT, WITH A FOCUS ON PAIN, FUNCTION, AND ADVERSE EVENTS. SEARCH METHODS: WE SEARCHED CENTRAL, MEDLINE, EMBASE, FIVE OTHER DATABASES AND FOUR TRIALS REGISTERS TO 11 MARCH 2016 WITHOUT RESTRICTION OF LANGUAGE OR PUBLICATION STATUS. WE SCREENED REFERENCE LISTS AND CONTACTED EXPERTS IN THE FIELD TO IDENTIFY ADDITIONAL STUDIES. SELECTION CRITERIA: WE INCLUDED RANDOMIZED CONTROLLED TRIALS OF YOGA TREATMENT IN PEOPLE WITH CHRONIC NON-SPECIFIC LOW BACK PAIN. WE INCLUDED STUDIES COMPARING YOGA TO ANY OTHER INTERVENTION OR TO NO INTERVENTION. WE ALSO INCLUDED STUDIES COMPARING YOGA AS AN ADJUNCT TO OTHER THERAPIES, VERSUS THOSE OTHER THERAPIES ALONE. DATA COLLECTION AND ANALYSIS: TWO AUTHORS INDEPENDENTLY SCREENED AND SELECTED STUDIES, EXTRACTED OUTCOME DATA, AND ASSESSED RISK OF BIAS. WE CONTACTED STUDY AUTHORS TO OBTAIN MISSING OR UNCLEAR INFORMATION. WE EVALUATED THE OVERALL CERTAINTY OF EVIDENCE USING THE GRADE APPROACH. MAIN RESULTS: WE INCLUDED 12 TRIALS (1080 PARTICIPANTS) CARRIED OUT IN THE USA (SEVEN TRIALS), INDIA (THREE TRIALS), AND THE UK (TWO TRIALS). STUDIES WERE UNFUNDED (ONE TRIAL), FUNDED BY A YOGA INSTITUTION (ONE TRIAL), FUNDED BY NON-PROFIT OR GOVERNMENT SOURCES (SEVEN TRIALS), OR DID NOT REPORT ON FUNDING (THREE TRIALS). MOST TRIALS USED IYENGAR, HATHA, OR VINIYOGA FORMS OF YOGA. THE TRIALS COMPARED YOGA TO NO INTERVENTION OR A NON-EXERCISE INTERVENTION SUCH AS EDUCATION (SEVEN TRIALS), AN EXERCISE INTERVENTION (THREE TRIALS), OR BOTH EXERCISE AND NON-EXERCISE INTERVENTIONS (TWO TRIALS). ALL TRIALS WERE AT HIGH RISK OF PERFORMANCE AND DETECTION BIAS BECAUSE PARTICIPANTS AND PROVIDERS WERE NOT BLINDED TO TREATMENT ASSIGNMENT, AND OUTCOMES WERE SELF-ASSESSED. THEREFORE, WE DOWNGRADED ALL OUTCOMES TO 'MODERATE' CERTAINTY EVIDENCE BECAUSE OF RISK OF BIAS, AND WHEN THERE WAS ADDITIONAL SERIOUS RISK OF BIAS, UNEXPLAINED HETEROGENEITY BETWEEN STUDIES, OR THE ANALYSES WERE IMPRECISE, WE DOWNGRADED THE CERTAINTY OF THE EVIDENCE FURTHER.FOR YOGA COMPARED TO NON-EXERCISE CONTROLS (9 TRIALS; 810 PARTICIPANTS), THERE WAS LOW-CERTAINTY EVIDENCE THAT YOGA PRODUCED SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE TO FOUR MONTHS (STANDARDIZED MEAN DIFFERENCE (SMD) -0.40, 95% CONFIDENCE INTERVAL (CI) -0.66 TO -0.14; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MEAN DIFFERENCE (MD) -2.18, 95% -3.60 TO -0.76), MODERATE-CERTAINTY EVIDENCE FOR SMALL TO MODERATE IMPROVEMENTS AT SIX MONTHS (SMD -0.44, 95% CI -0.66 TO -0.22; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -2.15, 95% -3.23 TO -1.08), AND LOW-CERTAINTY EVIDENCE FOR SMALL IMPROVEMENTS AT 12 MONTHS (SMD -0.26, 95% CI -0.46 TO -0.05; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -1.36, 95% -2.41 TO -0.26). ON A 0-100 SCALE THERE WAS VERY LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA WAS SLIGHTLY BETTER FOR PAIN AT THREE TO FOUR MONTHS (MD -4.55, 95% CI -7.04 TO -2.06), SIX MONTHS (MD -7.81, 95% CI -13.37 TO -2.25), AND 12 MONTHS (MD -5.40, 95% CI -14.50 TO -3.70), HOWEVER WE PRE-DEFINED CLINICALLY SIGNIFICANT CHANGES IN PAIN AS 15 POINTS OR GREATER AND THIS THRESHOLD WAS NOT MET. BASED ON INFORMATION FROM SIX TRIALS, THERE WAS MODERATE-CERTAINTY EVIDENCE THAT THE RISK OF ADVERSE EVENTS, PRIMARILY INCREASED BACK PAIN, WAS HIGHER IN YOGA THAN IN NON-EXERCISE CONTROLS (RISK DIFFERENCE (RD) 5%, 95% CI 2% TO 8%).FOR YOGA COMPARED TO NON-YOGA EXERCISE CONTROLS (4 TRIALS; 394 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE IN BACK-RELATED FUNCTION AT THREE MONTHS (SMD -0.22, 95% CI -0.65 TO 0.20; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -0.99, 95% -2.87 TO 0.90) AND SIX MONTHS (SMD -0.20, 95% CI -0.59 TO 0.19; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MD -0.90, 95% -2.61 TO 0.81), AND NO INFORMATION ON BACK-RELATED FUNCTION AFTER SIX MONTHS. THERE WAS VERY LOW-CERTAINTY EVIDENCE FOR LOWER PAIN ON A 0-100 SCALE AT SEVEN MONTHS (MD -20.40, 95% CI -25.48 TO -15.32), AND NO INFORMATION ON PAIN AT THREE MONTHS OR AFTER SEVEN MONTHS. BASED ON INFORMATION FROM THREE TRIALS, THERE WAS LOW-CERTAINTY EVIDENCE FOR NO DIFFERENCE IN THE RISK OF ADVERSE EVENTS BETWEEN YOGA AND NON-YOGA EXERCISE CONTROLS (RD 1%, 95% CI -4% TO 6%).FOR YOGA ADDED TO EXERCISE COMPARED TO EXERCISE ALONE (1 TRIAL; 24 PARTICIPANTS), THERE WAS VERY-LOW-CERTAINTY EVIDENCE FOR LITTLE OR NO DIFFERENCE AT 10 WEEKS IN BACK-RELATED FUNCTION (SMD -0.60, 95% CI -1.42 TO 0.22; CORRESPONDING TO A CHANGE IN THE OSWESTRY DISABILITY INDEX OF MD -17.05, 95% -22.96 TO 11.14) OR PAIN ON A 0-100 SCALE (MD -3.20, 95% CI -13.76 TO 7.36). THERE WAS NO INFORMATION ON OUTCOMES AT OTHER TIME POINTS. THERE WAS NO INFORMATION ON ADVERSE EVENTS.STUDIES PROVIDED LIMITED EVIDENCE ON RISK OF CLINICAL IMPROVEMENT, MEASURES OF QUALITY OF LIFE, AND DEPRESSION. THERE WAS NO EVIDENCE ON WORK-RELATED DISABILITY. AUTHORS' CONCLUSIONS: THERE IS LOW- TO MODERATE-CERTAINTY EVIDENCE THAT YOGA COMPARED TO NON-EXERCISE CONTROLS RESULTS IN SMALL TO MODERATE IMPROVEMENTS IN BACK-RELATED FUNCTION AT THREE AND SIX MONTHS. YOGA MAY ALSO BE SLIGHTLY MORE EFFECTIVE FOR PAIN AT THREE AND SIX MONTHS, HOWEVER THE EFFECT SIZE DID NOT MEET PREDEFINED LEVELS OF MINIMUM CLINICAL IMPORTANCE. IT IS UNCERTAIN WHETHER THERE IS ANY DIFFERENCE BETWEEN YOGA AND OTHER EXERCISE FOR BACK-RELATED FUNCTION OR PAIN, OR WHETHER YOGA ADDED TO EXERCISE IS MORE EFFECTIVE THAN EXERCISE ALONE. YOGA IS ASSOCIATED WITH MORE ADVERSE EVENTS THAN NON-EXERCISE CONTROLS, BUT MAY HAVE THE SAME RISK OF ADVERSE EVENTS AS OTHER BACK-FOCUSED EXERCISE. YOGA IS NOT ASSOCIATED WITH SERIOUS ADVERSE EVENTS. THERE IS A NEED FOR ADDITIONAL HIGH-QUALITY RESEARCH TO IMPROVE CONFIDENCE IN ESTIMATES OF EFFECT, TO EVALUATE LONG-TERM OUTCOMES, AND TO PROVIDE ADDITIONAL INFORMATION ON COMPARISONS BETWEEN YOGA AND OTHER EXERCISE FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. 2017 7 1345 43 HYPERTENSION ANALYSIS OF STRESS REDUCTION USING MINDFULNESS MEDITATION AND YOGA (THE HARMONY STUDY): STUDY PROTOCOL OF A RANDOMISED CONTROL TRIAL. INTRODUCTION: HYPERTENSION (HTN) IS A LEADING RISK FACTOR FOR PREVENTABLE CARDIOVASCULAR DISEASE, WITH OVER ONE IN FIVE ADULTS AFFECTED WORLDWIDE. LIFESTYLE MODIFICATION IS A KEY STRATEGY FOR THE PREVENTION AND TREATMENT OF HTN. STRESS HAS BEEN ASSOCIATED WITH GREATER CARDIOVASCULAR RISK, AND STRESS MANAGEMENT IS A RECOMMENDED INTERVENTION FOR HYPERTENSIVES. STRESS REDUCTION THROUGH RELAXATION THERAPIES HAS BEEN SHOWN TO HAVE AN EFFECT ON HUMAN PHYSIOLOGY, INCLUDING LOWERING BLOOD PRESSURE (BP). HOWEVER, INDIVIDUALISED BEHAVIOURAL INTERVENTIONS ARE RESOURCE INTENSIVE, AND GROUP STRESS MANAGEMENT APPROACHES HAVE NOT BEEN VALIDATED FOR REDUCING HTN. THE HARMONY STUDY IS A PILOT RANDOMISED CONTROLLED TRIAL DESIGNED TO DETERMINE IF MINDFULNESS-BASED STRESS REDUCTION (MBSR), A STANDARDISED GROUP THERAPY, IS AN EFFECTIVE INTERVENTION FOR LOWERING BP IN STAGE 1 UNMEDICATED HYPERTENSIVES. METHODS AND ANALYSIS: MEN AND WOMEN UNMEDICATED FOR HTN WITH MEAN DAYTIME AMBULATORY BLOOD PRESSURE (ABP) >/=135/85 MM HG OR 24 H ABP >/=130/80 MM HG ARE INCLUDED IN THE STUDY. SUBJECTS ARE RANDOMISED TO RECEIVE MBSR IMMEDIATELY OR AFTER A WAIT-LIST CONTROL PERIOD. THE PRIMARY OUTCOME MEASURE IS MEAN AWAKE AND 24 H ABP. THE PRIMARY OBJECTIVE OF THE HARMONY STUDY IS TO COMPARE ABP BETWEEN THE TREATMENT AND WAIT-LIST CONTROL ARM AT THE 12-WEEK PRIMARY ASSESSMENT PERIOD. RESULTS FROM THIS STUDY WILL DETERMINE IF MBSR IS AN EFFECTIVE INTERVENTION FOR LOWERING BP IN EARLY UNMEDICATED HYPERTENSIVES. ETHICS AND DISSEMINATION: THIS RESEARCH PROJECT WAS APPROVED BY THE SUNNYBROOK RESEARCH ETHICS BOARD AND THE UNIVERSITY HEALTH NETWORK RESEARCH ETHICS BOARD (TORONTO, CANADA). PLANNED ANALYSES ARE IN FULL COMPLIANCE WITH THE PRINCIPLES OF THE DECLARATION OF HELSINKI. DATA COLLECTION WILL BE COMPLETED BY EARLY SPRING 2012. PRIMARY AND SECONDARY ANALYSIS WILL COMMENCE IMMEDIATELY AFTER DATA MONITORING IS COMPLETED; DISSEMINATION PLANS INCLUDE PREPARING PUBLICATIONS FOR SUBMISSION DURING THE SUMMER OF 2012. TRIAL REGISTRATION NUMBER: THIS STUDY IS REGISTERED WITH HTTP://CLINICALTRIALS.GOV (NCT00825526). 2012 8 1331 30 HOME-BASED YOGA PROGRAM FOR THE PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA DURING CHEMOTHERAPY: A FEASIBILITY STUDY. BACKGROUND: YOGA IS PROVEN BENEFICIAL IN IMPROVING QUALITY OF LIFE AMONG BREAST CANCER SURVIVORS RECEIVING CHEMOTHERAPY, BUT ITS EFFECTIVENESS IN LYMPHOMA PATIENTS NEEDS TO BE EXPLORED. AS CHEMOTHERAPY-INDUCED NEUTROPENIA IS VERY COMMON AMONG LYMPHOMA PATIENTS, THEY ARE MUCH PRONE TO INFECTIONS FROM THE ENVIRONMENT. FURTHERMORE, TRAINED YOGA INSTRUCTORS ARE NOT AVAILABLE IN EVERY SETTING, SO THERE IS A NEED TO DEVELOP HOME-BASED YOGA PROGRAM MODULES FOR LYMPHOMA PATIENTS RECEIVING CHEMOTHERAPY. AIM: THE AIM OF THE STUDY WAS TO EXPLORE THE FEASIBILITY AND SAFETY OF YOGIC EXERCISES AMONG LYMPHOMA PATIENTS DURING CHEMOTHERAPY. SUBJECTS AND METHODS: AN INTERVENTIONAL, SINGLE-ARM PREPOST DESIGN STUDY WAS CONDUCTED AT A TERTIARY HEALTH-CARE CENTER. PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA (18-65 YEARS) WITH EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS FROM 0 TO 2, PLANNED TO RECEIVE CHEMOTHERAPY WERE ADMINISTERED A HOME-BASED YOGA PROGRAM OVER A PERIOD OF 2 MONTHS FROM THE START OF CHEMOTHERAPY. THE PRIMARY OUTCOME VARIABLES WERE RETENTION RATE, ACCEPTANCE RATE, SAFETY, AND ADHERENCE. HEALTH-RELATED QUALITY OF LIFE (HRQOL), FATIGUE LEVEL, OVERALL SLEEP QUALITY, DEPRESSION, ANXIETY LEVEL, AND PAIN WERE ALSO ASSESSED. STATISTICAL ANALYSIS: DESCRIPTIVE STATISTICS WAS USED TO SEE THE FEASIBILITY AND ADHERENCE. THE PAIRED T-TEST WAS USED TO COMPARE VARIOUS PRE AND POSTINTERVENTION OUTCOME MEASURES. RESULTS: FOURTEEN PATIENTS (MEDIAN AGE: 36 YEARS, RANGE13-65 YEARS) OF MALIGNANT LYMPHOMA WERE ENROLLED IN THE STUDY. MALE-TO-FEMALE RATIO WAS 9:5. NON-HODGKIN'S LYMPHOMA PATIENTS CONSTITUTED 64%. THE RECRUITMENT RATE WAS 93%. FAVORABLE RETENTION (100%), ACCEPTABILITY (97%), ADHERENCE (78.6%), AND NO SERIOUS ADVERSE EVENTS FOLLOWING YOGA PRACTICE WERE REPORTED. IMPROVEMENT WAS ALSO FOUND IN HRQOL, FATIGUE, SLEEP, DEPRESSION, AND ANXIETY. HOWEVER, IT NEEDS FURTHER VALIDATION IN A RANDOMIZED STUDY. CONCLUSION: HOME-BASED YOGA PROGRAM IS SAFE AND FEASIBLE AMONG THE PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA RECEIVING CHEMOTHERAPY. 2018 9 613 41 DEVELOPMENT OF A YOGA PROGRAM FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. INTRODUCTION: MANY INDIANS ARE AT HIGH-RISK OF TYPE-2 DIABETES MELLITUS (T2DM). YOGA IS AN ANCIENT INDIAN MIND-BODY DISCIPLINE, THAT HAS BEEN ASSOCIATED WITH IMPROVED GLUCOSE LEVELS AND CAN HELP TO PREVENT T2DM. THE STUDY AIMED TO SYSTEMATICALLY DEVELOP A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA USING A COMPLEX INTERVENTION DEVELOPMENT APPROACH. MATERIALS AND METHODS: AS PART OF THE INTERVENTION, WE DEVELOPED A BOOKLET AND A HIGH-DEFINITION VIDEO FOR PARTICIPANTS AND A MANUAL FOR YOGA-DP INSTRUCTORS. A SYSTEMATIC ITERATIVE PROCESS WAS FOLLOWED TO DEVELOP THE INTERVENTION AND INCLUDED FIVE STEPS: (I) A SYSTEMATIC REVIEW OF THE LITERATURE TO GENERATE A LIST OF YOGIC PRACTICES THAT IMPROVES BLOOD GLUCOSE LEVELS AMONG ADULTS AT HIGH-RISK OF OR WITH T2DM, (II) VALIDATION OF IDENTIFIED YOGIC PRACTICES BY YOGA EXPERTS, (III) DEVELOPMENT OF THE INTERVENTION, (IV) CONSULTATION WITH YOGA, EXERCISE, PHYSICAL ACTIVITY, DIET, BEHAVIOR CHANGE, AND/OR DIABETES EXPERTS ABOUT THE INTERVENTION, AND (V) PRETEST THE INTERVENTION AMONG YOGA PRACTITIONERS AND LAY PEOPLE (THOSE AT RISK OF T2DM AND HAD NOT PRACTICED YOGA BEFORE) IN INDIA. RESULTS: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAM, PROVIDED OVER A PERIOD OF 24 WEEKS. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES), AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. ONCE PARTICIPANTS COMPLETE THE PROGRAM, THEY ARE STRONGLY ENCOURAGED TO MAINTAIN A HEALTHY LIFESTYLE IN THE LONG-TERM. CONCLUSIONS: WE SYSTEMATICALLY DEVELOPED A NOVEL YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE IN INDIA. A MULTI-CENTER FEASIBILITY RANDOMIZED CONTROLLED TRIAL IS IN PROGRESS IN INDIA. 2020 10 2035 28 TELE-YOGA FOR CHRONIC PAIN: CURRENT STATUS AND FUTURE DIRECTIONS. PAIN IS A PERVASIVE, DEBILITATING DISORDER THAT IS RESISTANT TO LONG-TERM PHARMACOLOGICAL INTERVENTIONS. ALTHOUGH PSYCHOLOGICAL THERAPIES SUCH AS COGNITIVE BEHAVIOR THERAPY DEMONSTRATE MODERATE EFFICACY, MANY INDIVIDUALS CONTINUE TO HAVE ONGOING DIFFICULTIES FOLLOWING TREATMENT. THERE IS A CURRENT TREND TO ESTABLISH COMPLEMENTARY AND INTEGRATIVE HEALTH INTERVENTIONS FOR CHRONIC PAIN, FOR WHICH YOGA HAS BEEN FOUND TO HAVE EXCITING POTENTIAL. NEVERTHELESS, AN IMPORTANT CONSIDERATION WITHIN THE FIELD IS ACCESSIBILITY TO ADEQUATE CARE. TELEHEALTH CAN BE USED TO PROVIDE REAL-TIME INTERACTIVE VIDEO CONFERENCING LEADING TO INCREASED ACCESS TO HEALTH CARE FOR INDIVIDUALS LOCATED REMOTELY OR WHO OTHERWISE HAVE DIFFICULTY ACCESSING SERVICES, PERHAPS THROUGH ISSUES OF MOBILITY OR PROXIMITY OF ADEQUATE SERVICES. THIS ARTICLE ASSESSES THE CURRENT STATUS AND FEASIBILITY OF IMPLEMENTING TELE-YOGA FOR CHRONIC PAIN. METHODOLOGICAL LIMITATIONS AND RECOMMENDATIONS FOR FUTURE RESEARCH ARE DISCUSSED. 2018 11 2843 28 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS. 2021 12 2763 37 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893. 2021 13 2130 41 THE EFFECTIVENESS OF YOGA TO PREVENT DIABETES MELLITUS TYPE 2: A PROTOCOL FOR SYSTEMATIC REVIEW AND META-ANALYSIS. BACKGROUND: TYPE 2 DIABETES MELLITUS (T2DM) IS BECOMING A LEADING PROBLEM WORLDWIDE. EMERGING REPORTS REVEAL ALARMING EVIDENCE OF INCREASING PREVALENCE OF T2DM THAT HAS REACHED PANDEMIC LEVELS. DESPITE THE SIGNIFICANT INCIDENCE, THERE ARE LIMITED RELIABLE DATA RESOURCES AND COMPREHENSIVE SYSTEMATIC REVIEW AND META-ANALYSIS ON THE EFFECTS OF YOGA ON PEOPLE WHO ARE A PREDIABETIC OR HIGH RISK FOR DEVELOPING T2DM. OBJECTIVE: THE OBJECTIVE OF THIS PROTOCOL IS TO CONDUCT A FULL-SCALE SYSTEMATIC REVIEW AND META-ANALYSES ON THE EFFECTS OF YOGA ON PEOPLE WHO ARE PREDIABETES OR HIGH RISK OF DEVELOPING T2DM. METHODS: THE ARTICLES ENROLLED IN THE STUDY WILL BE RETRIEVED FROM THE ONLINE DATABASES BETWEEN 2002 AND THE DATE THE SEARCHES ARE EXECUTED. THE SEARCHES WILL BE REPEATED JUST BEFORE THE FINAL ANALYSES AND FURTHER RELEVANT STUDIES FOR INCLUSION. WE WILL CONDUCT A BIBLIOGRAPHIC SEARCH IN DATABASES: MEDLINE/PUBMED, SCOPUS, COCHRANE LIBRARY, EBSCO, AND INDMED USING KEYWORDS INCLUDING PREDIABETES STATE, HIGH RISK FOR DIABETES, METABOLIC SYNDROME, AND YOGA. A DEFINED SEARCH STRATEGY WILL BE IMPLEMENTED ALONG WITH SELECTION CRITERIA TO OBTAIN FULL-TEXT ARTICLES OF RELEVANT STUDIES. THIS STUDY PROTOCOL WAS PREPARED ACCORDING TO THE PREFERRED REPORTING ITEMS FOR SYSTEMATIC REVIEWS AND META-ANALYSIS FOR PROTOCOLS 2015 GUIDELINES. THERE WILL BE NO LANGUAGE RESTRICTIONS. ETHICS AND DISSEMINATION: THE PROPOSED STUDY WILL BE BASED ON PUBLISHED STUDIES AND PUBLICLY AVAILABLE ANONYMIZED DATA WITHOUT DIRECTLY INVOLVING HUMAN PARTICIPANTS AND THEREFORE REQUIRES NEITHER FORMAL HUMAN ETHICAL REVIEW NOR APPROVAL BY A HUMAN RESEARCH ETHICS COMMITTEE. WE PUBLISHED AN OUTLINE OF THE PROTOCOL IN THE INTERNATIONAL PROSPECTIVE REGISTER OF SYSTEMATIC REVIEWS (PROSPERO) IN 2018. WE PLAN TO DISSEMINATE THE FINDINGS OF THIS SYSTEMATIC REVIEW AND META-ANALYSIS THROUGH PUBLICATION IN A PEER-REVIEWED JOURNAL AND PRESENTATION AT RELEVANT CONFERENCE PROCEEDINGS. IN ADDITION, WE BELIEVE THE RESULTS OF THE SYSTEMATIC REVIEW WILL HAVE IMPLICATIONS FOR POLICY AND PRACTICE. WE WILL PREPARE POLICYMAKER SUMMARY USING A VALIDATED FORMAT, DISSEMINATE THROUGH SOCIAL MEDIA AND EMAIL DISCUSSION GROUPS. REVIEW REGISTRATION NUMBER: PROSPERO REGISTRATION NUMBER CRD 42018106657. 2019 14 1370 44 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 15 2496 39 YOGA AS PART OF A PACKAGE OF CARE VERSUS NON-STANDARD CARE FOR SCHIZOPHRENIA. BACKGROUND: YOGA IS AN ANCIENT BODY-MIND PRACTICE WHICH ORIGINATED IN INDIA AND IS POPULAR IN THE WESTERN WORLD AS A FORM OF RELAXATION AND EXERCISE. IT HAS BEEN OF INTEREST FOR PEOPLE WITH SCHIZOPHRENIA TO DETERMINE THE EFFICACY OF YOGA DELIVERED AS A PACKAGE OF CARE VERSUS NON-STANDARD CARE. OBJECTIVES: TO EXAMINE THE EFFECTS OF YOGA AS PART OF A PACKAGE OF CARE VERSUS NON-STANDARD CARE FOR SCHIZOPHRENIA. SEARCH METHODS: WE SEARCHED THE COCHRANE SCHIZOPHRENIA GROUP TRIALS REGISTER (LATEST 15 MAY 2018) WHICH IS BASED ON REGULAR SEARCHES OF MEDLINE, PUBMED, EMBASE, CINAHL, BIOSS, AMED, PSYCHINFO, AND REGISTRIES OF CLINICAL TRIALS. WE SEARCHED THE REFERENCES OF ALL INCLUDED STUDIES. THERE ARE NO LANGUAGE, DATE, DOCUMENT TYPE, OR PUBLICATION STATUS LIMITATIONS FOR INCLUSION OF RECORDS IN THE REGISTER. SELECTION CRITERIA: ALL RANDOMISED CONTROLLED TRIALS (RCTS) INCLUDING PEOPLE WITH SCHIZOPHRENIA COMPARING YOGA AS PART OF A PACKAGE OF CARE WITH NON-STANDARD CARE. DATA COLLECTION AND ANALYSIS: THERE WERE NO DATA TO ANALYSE AS NO STUDIES MET THE INCLUSION CRITERIA. MAIN RESULTS: THE SEARCHES IDENTIFIED 30 STUDIES THAT COULD BE RELEVANT TO THIS REVIEW. AFTER CAREFUL INSPECTION, 29 WERE EXCLUDED AND ONE IS AWAITING CLASSIFICATION. NO DATA WERE AVAILABLE FOR ANALYSES. AUTHORS' CONCLUSIONS: IN VIEW OF THE LACK OF EVIDENCE FROM RCTS, IT IS CURRENTLY NOT POSSIBLE FOR US TO COMMENT ON THE USE OF YOGA AS PART OF A PACKAGE OF CARE VERSUS NON-STANDARD CARE. 2019 16 1295 46 GUIDELINES FOR TEACHING YOGA TO WOMEN WITH BREAST CANCER-RELATED LYMPHOEDEMA: AN EVIDENCE-BASED APPROACH. BREAST CANCER-RELATED LYMPHOEDEMA (BCRL) IS A CHRONIC CONDITION THAT REQUIRES LIFELONG MANAGEMENT TO PREVENT THE CONDITION WORSENING AND TO REDUCE THE THREAT OF INFECTION. WOMEN ARE AFFECTED IN ALL DOMAINS OF THEIR LIFE. AS A HOLISTIC PRACTICE, YOGA MAY BE OF BENEFIT BY REDUCING BOTH THE PHYSICAL AND PSYCHOSOCIAL EFFECTS OF LYMPHOEDEMA. WOMEN WITH BCRL ARE ATTENDING YOGA CLASSES IN INCREASING NUMBERS, SO IT IS ESSENTIAL THAT YOGA BE BASED ON PRINCIPLES THAT ENSURE LYMPHOEDEMA IS CONTROLLED AND NOT EXACERBATED. TWO RANDOMISED CONTROLLED TRIALS WITH A YOGA INTERVENTION HAVE HAD POSITIVE RESULTS AFTER AN 8-WEEK INTERVENTION (N=28) AND 6-MONTHS AFTER A 4-WEEK INTERVENTION (N=18). THE FIRST STUDY HAD SEVERAL SIGNIFICANT RESULTS AND WOMEN REPORTED INCREASED BIOPSYCHOSOCIAL IMPROVEMENTS. BOTH STUDIES SHOWED TRENDS TO IMPROVED LYMPHOEDEMA STATUS. THE YOGA INTERVENTIONS COMPROMISED BREATHING, PHYSICAL POSTURES, MEDITATION AND RELAXATION PRACTICES BASED ON SATYANANDA YOGA(R), WITH MODIFICATIONS TO PROMOTE LYMPHATIC DRAINAGE AND FOLLOWING PRINCIPLES OF BEST CURRENT CARE FOR THOSE WITH BCRL. INDIVIDUAL NEEDS WERE CONSIDERED. THE YOGA PROTOCOL THAT WAS USED IN THE 8-WEEK TRIAL IS PRESENTED. OUR AIM IS TO PROVIDE PRINCIPLES FOR YOGA TEACHERS/THERAPISTS WORKING WITH THIS CLIENTELE THAT CAN BE ADAPTED TO OTHER YOGA STYLES. FURTHER, THESE PRINCIPLES MAY PROVIDE A BASIS FOR THE DEVELOPMENT OF YOGA PROGRAMS FOR PEOPLE WITH SECONDARY LYMPHOEDEMA IN OTHER AREAS OF THEIR BODY AS THE POPULATION REQUIRING CANCER TREATMENT CONTINUES TO INCREASE. WHILST THE STYLE OF YOGA PRESENTED HERE HAS HAD POSITIVE OUTCOMES, FURTHER APPLICATION AND RESEARCH IS NEEDED TO FULLY DEMONSTRATE ITS EFFECTIVENESS. 2017 17 603 31 DEVELOPMENT AND VALIDATION OF INTEGRATED YOGA MODULE FOR OBESITY IN ADOLESCENTS. BACKGROUND: OBESITY IS A GROWING GLOBAL EPIDEMIC AND CAUSE OF NONCOMMUNICABLE DISEASES. YOGA IS ONE OF THE EFFECTIVE WAYS TO REDUCE STRESS WHICH IS ONE OF THE CAUSES OF OBESITY. NOWADAYS, CHILDREN IN ADOLESCENT AGE ARE MORE PRONE TO GET OBESE DUE TO LACK OF PHYSICAL ACTIVITY MAKING THEM MORE SEDENTARY. AIM: TO IDENTIFY THE DESIGN AND VALIDATION OF INTEGRATED APPROACH OF YOGA THERAPY MODULE (IAYTM) FOR OBESITY IN ADOLESCENTS. MATERIALS AND METHODS: FIRST PHASE - IAYTM FOR OBESITY WAS DESIGNED BASED ON THE LITERATURE REVIEW OF CLASSICAL TEXTS AND RECENTLY PUBLISHED RESEARCH ARTICLES. SECOND PHASE - DESIGNED IAYTM WAS VALIDATED BY 16 SUBJECT MATTER (YOGA) EXPERTS. CONTENT-VALIDITY RATIO (CVR) WAS ANALYZED USING LAWSHE'S FORMULA. RESULTS: YOGA PRACTICES WERE DESIGNED FOR INTEGRATED YOGA MODULE FOR OBESITY IN ADOLESCENTS. YOGA PRACTICES WITH CVR >/=0.5 AND WHICH WERE VALIDATED BY 16 YOGA EXPERTS AND APPROVED IN FACULTY GROUP DISCUSSION WERE INCLUDED IN FINAL INTEGRATED YOGA THERAPY MODULE. CONCLUSION: THE YOGA PRACTICES WERE DESIGNED AND VALIDATED FOR IAYTM FOR OBESITY IN ADOLESCENTS. 2018 18 2638 33 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS. 2016 19 2093 35 THE EFFECT OF YOCAS(C)(R) YOGA FOR MUSCULOSKELETAL SYMPTOMS AMONG BREAST CANCER SURVIVORS ON HORMONAL THERAPY. UP TO 50% OF BREAST CANCER SURVIVORS ON AROMATASE INHIBITOR THERAPY REPORT MUSCULOSKELETAL SYMPTOMS SUCH AS JOINT AND MUSCLE PAIN, SIGNIFICANTLY IMPACTING TREATMENT ADHERENCE AND DISCONTINUATION RATES. WE CONDUCTED A SECONDARY DATA ANALYSIS OF A NATIONWIDE, MULTI-SITE, PHASE II/III RANDOMIZED, CONTROLLED, CLINICAL TRIAL EXAMINING THE EFFICACY OF YOGA FOR IMPROVING MUSCULOSKELETAL SYMPTOMS AMONG BREAST CANCER SURVIVORS CURRENTLY RECEIVING HORMONE THERAPY (AROMATASE INHIBITORS [AI] OR TAMOXIFEN [TAM]). BREAST CANCER SURVIVORS CURRENTLY RECEIVING AI (N = 95) OR TAM (N = 72) WITH NO PARTICIPATION IN YOGA DURING THE PREVIOUS 3 MONTHS WERE RANDOMIZED INTO 2 ARMS: (1) STANDARD CARE MONITORING AND (2) STANDARD CARE PLUS THE 4-WEEK YOGA INTERVENTION (2X/WEEK; 75 MIN/SESSION) AND INCLUDED IN THIS ANALYSIS. THE YOGA INTERVENTION UTILIZED THE UR YOGA FOR CANCER SURVIVORS (YOCAS(C)((R))) PROGRAM CONSISTING OF BREATHING EXERCISES, 18 GENTLE HATHA AND RESTORATIVE YOGA POSTURES, AND MEDITATION. MUSCULOSKELETAL SYMPTOMS WERE ASSESSED PRE- AND POST-INTERVENTION. AT BASELINE, AI USERS REPORTED HIGHER LEVELS OF GENERAL PAIN, MUSCLE ACHES, AND TOTAL PHYSICAL DISCOMFORT THAN TAM USERS (ALL P