1 2577 135 YOGA FOR GENERALIZED ANXIETY DISORDER: DESIGN OF A RANDOMIZED CONTROLLED CLINICAL TRIAL. GENERALIZED ANXIETY DISORDER (GAD) IS A COMMON DISORDER ASSOCIATED WITH SIGNIFICANT DISTRESS AND INTERFERENCE. ALTHOUGH COGNITIVE BEHAVIORAL THERAPY (CBT) HAS BEEN SHOWN TO BE THE MOST EFFECTIVE FORM OF PSYCHOTHERAPY, FEW PATIENTS RECEIVE OR HAVE ACCESS TO THIS INTERVENTION. YOGA THERAPY OFFERS ANOTHER PROMISING, YET UNDER-RESEARCHED, INTERVENTION THAT IS GAINING INCREASING POPULARITY IN THE GENERAL PUBLIC, AS AN ANXIETY REDUCTION INTERVENTION. THE PURPOSE OF THIS INNOVATIVE CLINICAL TRIAL PROTOCOL IS TO INVESTIGATE THE EFFICACY OF A KUNDALINI YOGA INTERVENTION, RELATIVE TO CBT AND A CONTROL CONDITION. KUNDALINI YOGA AND CBT ARE COMPARED WITH EACH OTHER IN A NONINFERIORITY TEST AND BOTH TREATMENTS ARE COMPARED TO STRESS EDUCATION TRAINING, AN ATTENTION CONTROL INTERVENTION, IN SUPERIORITY TESTS. THE SAMPLE WILL CONSIST OF 230 INDIVIDUALS WITH A PRIMARY DSM-5 DIAGNOSIS OF GAD. THIS RANDOMIZED CONTROLLED TRIAL WILL COMPARE YOGA (N=95) TO BOTH CBT FOR GAD (N=95) AND STRESS EDUCATION (N=40), A COMMONLY USED CONTROL CONDITION. ALL THREE TREATMENTS WILL BE ADMINISTERED BY TWO INSTRUCTORS IN A GROUP FORMAT OVER 12 WEEKLY SESSIONS WITH FOUR TO SIX PATIENTS PER GROUP. GROUPS WILL BE RANDOMIZED USING PERMUTED BLOCK RANDOMIZATION, WHICH WILL BE STRATIFIED BY SITE. TREATMENT OUTCOME WILL BE EVALUATED BI-WEEKLY AND AT 6MONTH FOLLOW-UP. FURTHERMORE, POTENTIAL MEDIATORS OF TREATMENT OUTCOME WILL BE INVESTIGATED. GIVEN THE INDIVIDUAL AND ECONOMIC BURDEN ASSOCIATED WITH GAD, IDENTIFYING ACCESSIBLE ALTERNATIVE BEHAVIORAL TREATMENTS WILL HAVE SUBSTANTIVE PUBLIC HEALTH IMPLICATIONS. 2015 2 181 50 A RANDOMIZED CONTROLLED TRIAL OF YOGA VS NONAEROBIC EXERCISE FOR VETERANS WITH PTSD: UNDERSTANDING EFFICACY, MECHANISMS OF CHANGE, AND MODE OF DELIVERY. BACKGROUND AND OBJECTIVES: POSTTRAUMATIC STRESS DISORDER (PTSD) IS A CHRONIC, DISABLING, AND PREVALENT MENTAL HEALTH DISORDER AMONG VETERANS. DESPITE THE AVAILABILITY OF EMPIRICALLY SUPPORTED PSYCHOTHERAPIES, MANY VETERANS REMAIN SYMPTOMATIC AFTER TREATMENT AND/OR PREFER TO SEEK COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES, INCLUDING YOGA, TO MANAGE PTSD. THE RANDOMIZED CONTROLLED TRIAL (RCT) DESCRIBED HEREIN WILL EVALUATE THE EFFICACY OF A MANUALIZED YOGA PROGRAM AS COMPARED TO NONAEROBIC EXERCISE IN REDUCING PTSD SEVERITY AMONG VETERANS. A SECONDARY AIM OF THIS STUDY IS TO BETTER UNDERSTAND THE MECHANISMS OF CHANGE. METHODS: VETERANS (N = 192) WITH PTSD WILL BE RANDOMIZED TO HATHA YOGA OR NONAEROBIC PHYSICAL ACTIVITY CONTROL; BOTH GROUPS CONSIST OF 12 WEEKLY, 60-MIN GROUP OR ONLINE TRAINING SESSIONS WITH 15-20 MIN OF DAILY AT-HOME PRACTICE. OUTCOME MEASURES WILL BE ADMINISTERED AT BASELINE, MID-TREATMENT, POSTTREATMENT, AND 12-WEEK FOLLOW-UP. PROJECTED OUTCOMES: THIS STUDY WILL EVALUATE CHANGES IN PTSD SEVERITY (PRIMARY OUTCOME) AS WELL AS DEPRESSION, ANXIETY, ANGER, SLEEP PROBLEMS, AND PSYCHOSOCIAL DISABILITY (SECONDARY OUTCOMES). WE WILL ALSO USE MULTIPLE MEDIATION TO EXAMINE TWO POTENTIAL MODELS OF THE MECHANISMS OF CLINICAL EFFECT: THE ATTENTION MODEL (I.E., YOGA INCREASES ATTENTIONAL CONTROL, WHICH REDUCES PTSD SYMPTOMS), THE COPING MODEL (I.E., YOGA INCREASES DISTRESS TOLERANCE, WHICH IMPROVES COPING, WHICH REDUCES PTSD SYMPTOMS), AND THE COMBINATION OF THESE MODELS. THIS ASPECT OF THE STUDY IS INNOVATIVE AND IMPORTANT GIVEN THE ABSENCE OF AN EXISTING, COMPREHENSIVE MODEL FOR UNDERSTANDING YOGA'S IMPACT ON PTSD. ULTIMATELY, WE HOPE TO DEVELOP GUIDELINES FOR APPLICATION OF YOGA TO PTSD RECOVERY. 2021 3 2638 42 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 4 2843 37 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 5 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 6 1093 41 EFFECTS OF YOGA ON WELL-BEING AND HEALTHY AGEING: STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (FITFORAGE). INTRODUCTION: DUE TO AGEING POPULATIONS WORLDWIDE, THE BURDEN OF DISABILITY IS INCREASING. IT IS THEREFORE IMPORTANT TO DEVELOP INTERVENTIONS THAT IMPROVE HEALTHY AGEING, REDUCE DISABILITY ONSET AND ENHANCE LIFE QUALITY. PHYSICAL ACTIVITY CAN PROMOTE HEALTHY AGEING AND HELP MAINTAIN INDEPENDENCE, YET MANY OLDER ADULTS ARE INACTIVE. YOGA IS A FORM OF PHYSICAL ACTIVITY THAT AIMS TO IMPROVE HEALTH AND MAY BE PARTICULARLY SUITABLE FOR OLDER ADULTS. RESEARCH INDICATES POSITIVE EFFECTS OF YOGA ON SEVERAL HEALTH-RELATED OUTCOMES; HOWEVER, EMPIRICAL STUDIES EXAMINING THE BENEFITS OF YOGA ON WELL-BEING AMONG THE ELDERLY REMAIN SCARCE. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 12-WEEK YOGA PROGRAMME AIMED TO IMPROVE HEALTH AND WELL-BEING AMONG PHYSICALLY INACTIVE OLDER ADULTS. METHODS AND ANALYSIS: THREE GROUP PARALLEL, SINGLE-BLIND RANDOMISED CONTROLLED TRIAL. TWO COMPARISON GROUPS ARE INCLUDED: AEROBIC EXERCISE AND A NON-ACTIVE WAIT-LIST CONTROL. IN TOTAL, 180 PARTICIPANTS AGED 65-85 YEARS WILL BE RECRUITED. ASSESSMENTS WILL BE PERFORMED AT BASELINE AND POSTINTERVENTION (12-WEEK FOLLOW-UP). THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE PHYSICAL ACTIVITY/SEDENTARY BEHAVIOUR, MOBILITY/FALL RISK, COGNITION, DEPRESSION, ANXIETY, MOOD, STRESS, PAIN, SLEEP QUALITY, SOCIAL SUPPORT AND CARDIOMETABOLIC RISK FACTORS. DATA WILL BE ANALYSED USING INTENTION-TO-TREAT ANALYSES, WITH MIXED LINEAR MODELLING. ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE ETHICAL REVIEW BOARD IN STOCKHOLM (2017/1862-31/2). ALL PARTICIPANTS MUST VOLUNTARILY AGREE TO PARTICIPATE AND ARE FREE TO WITHDRAW FROM THE STUDY AT ANY POINT. WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. A SUMMARY OF KEY RESULTS WILL BE PUBLICLY AVAILABLE THROUGH NEWSPAPER ARTICLES. TRIAL REGISTRATION NUMBER: DRKS00015093, U1111-1217-4248. 2019 7 2035 34 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 8 1370 50 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 9 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 10 1591 44 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 11 536 43 COMPARISON OF YOGA VERSUS STRETCHING FOR CHRONIC LOW BACK PAIN: PROTOCOL FOR THE YOGA EXERCISE SELF-CARE (YES) TRIAL. BACKGROUND: BACK PAIN, ONE OF THE MOST PREVALENT CONDITIONS AFFLICTING AMERICAN ADULTS, IS THE LEADING REASON FOR USING COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES. YOGA IS AN INCREASINGLY POPULAR "MIND-BODY" CAM THERAPY OFTEN USED FOR RELIEVING BACK PAIN AND SEVERAL SMALL STUDIES HAVE FOUND YOGA EFFECTIVE FOR THIS CONDITION. THIS STUDY WILL ASSESS WHETHER YOGA IS EFFECTIVE FOR TREATING CHRONIC LOW BACK PAIN COMPARED WITH SELF CARE AND EXERCISE AND WILL EXPLORE THE MECHANISMS RESPONSIBLE FOR ANY OBSERVED BENEFITS. METHODS/DESIGN: A TOTAL OF 210 PARTICIPANTS WITH LOW BACK PAIN LASTING AT LEAST 3 MONTHS WILL BE RECRUITED FROM PRIMARY CARE CLINICS OF A LARGE HEALTHCARE SYSTEM BASED IN SEATTLE. THEY WILL BE RANDOMIZED IN A 2:2:1 RATIO TO RECEIVE 12 WEEKLY YOGA CLASSES, 12 WEEKLY CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OF COMPARABLE PHYSICAL EXERTION, OR A SELF-CARE BOOK. INTERVIEWERS MASKED TO PARTICIPANTS' TREATMENT GROUP WILL ASSESS OUTCOMES AT BASELINE AND 6, 12 AND 26 WEEKS AFTER RANDOMIZATION. PRIMARY OUTCOMES WILL BE BACK-RELATED DYSFUNCTION AND SYMPTOM BOTHERSOMENESS. IN ADDITION, DATA WILL BE COLLECTED ON PHYSICAL MEASUREMENTS (E.G., FLEXION) AT BASELINE AND 12 WEEKS AND SALIVA SAMPLES WILL BE OBTAINED AT BASELINE, 6 AND 12 WEEKS. INFORMATION WILL BE COLLECTED ON SPECIFIC PHYSICAL, PSYCHOLOGICAL, AND PHYSIOLOGICAL FACTORS TO ALLOW EXPLORATION OF POSSIBLE MECHANISMS OF ACTION THROUGH WHICH YOGA COULD RELIEVE BACK PAIN AND DYSFUNCTION. THE EFFECTIVENESS OF YOGA WILL BE ASSESSED USING ANALYSIS OF COVARIANCE (USING GENERAL ESTIMATING EQUATIONS - GEE) WITHIN AN INTENTION-TO-TREAT CONTEXT. IF YOGA IS FOUND EFFECTIVE, FURTHER ANALYSES WILL EXPLORE WHETHER YOGA'S BENEFITS ARE ATTRIBUTABLE TO PHYSICAL, PSYCHOLOGICAL AND/OR PHYSIOLOGICAL FACTORS. CONCLUSIONS: THIS STUDY WILL PROVIDE THE CLEAREST EVIDENCE TO DATE ABOUT THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR TREATING CHRONIC BACK PAIN, AND IF THE RESULTS ARE POSITIVE, WILL HELP FOCUS FUTURE, MORE IN-DEPTH, RESEARCH ON THE MOST PROMISING POTENTIAL MECHANISMS OF ACTION IDENTIFIED BY THIS STUDY. 2010 12 258 42 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 13 2389 53 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823. 2020 14 1480 32 INTEGRATING YOGA INTO CANCER CARE. ALTHOUGH YOGA HAS BEEN PRACTICED IN EASTERN CULTURE FOR THOUSANDS OF YEARS AS PART OF LIFE PHILOSOPHY, CLASSES IN THE UNITED STATES ONLY RECENTLY HAVE BEEN OFFERED TO PEOPLE WITH CANCER. THE WORD YOGA IS DERIVED FROM THE SANSKRIT ROOT YUJ, MEANING TO BIND, JOIN, AND YOKE. THIS REFLECTION OF THE UNION OF THE BODY, MIND, AND SPIRIT IS WHAT DIFFERENTIATES YOGA FROM GENERAL EXERCISE PROGRAMS. YOGA CLASSES IN THE UNITED STATES GENERALLY CONSIST OF ASANAS (POSTURES), WHICH ARE DESIGNED TO EXERCISE EVERY MUSCLE, NERVE, AND GLAND IN THE BODY. THE POSTURES ARE COMBINED WITH PRANAYAMA, OR RHYTHMIC CONTROL OF THE BREATH. AS A COMPLEMENTARY THERAPY, YOGA INTEGRATES AWARENESS OF BREATH, RELAXATION, EXERCISE, AND SOCIAL SUPPORT--ELEMENTS THAT ARE KEY TO ENHANCING QUALITY OF LIFE IN PATIENTS WITH CANCER. YOGA PRACTICE MAY ASSIST CANCER SURVIVORS IN MANAGING SYMPTOMS SUCH AS DEPRESSION, ANXIETY, INSOMNIA, PAIN, AND FATIGUE. AS WITH ALL EXERCISE PROGRAMS, PARTICIPANTS NEED TO BE AWARE OF POTENTIAL RISKS AND THEIR OWN LIMITATIONS. THE PURPOSE OF THIS ARTICLE IS TO FAMILIARIZE NURSES WITH YOGA AS A COMPLEMENTARY THERAPY, INCLUDING CURRENT RESEARCH FINDINGS, TYPES OF YOGA, POTENTIAL BENEFITS, SAFETY CONCERNS, TEACHER TRAINING, AND WAYS TO INTEGRATE YOGA INTO CANCER CARE. 2008 15 2121 41 THE EFFECTIVENESS AND CHARACTERISTICS OF PREGNANCY YOGA INTERVENTIONS: A SYSTEMATIC REVIEW PROTOCOL. BACKGROUND: THE PURPOSE OF THIS REVIEW IS TO SYSTEMATICALLY EXAMINE THE REPORTED CLINICAL EFFECTIVENESS OF PREGNANCY YOGA. THE REVIEW WILL USE THE FITT (FREQUENCY, INTENSITY, TIME/DURATION AND TYPE) PRINCIPLE OF PHYSICAL ACTIVITY TO CHARACTERISE THE DIFFERENT TYPES OF YOGA INTERVENTIONS THAT HAVE BEEN EVALUATED IN THE INCLUDED STUDIES. STUDIES WILL BE CATEGORISED AS EFFECTIVENESS OR EFFICACY STUDIES AND THIS CONTINUUM OF EFFICACY VERSUS EFFECTIVENESS WILL BE INCORPORATED INTO THE FULL REVIEW. METHODS/DESIGN: THE FOLLOWING ELECTRONIC DATABASES WILL BE SEARCHED USING A DETAILED SEARCH STRATEGY: MEDLINE, PSYCINFO, EMBASE, CINAHL, WHOLIS, AMED, SCIELO, ASSIA AND WEB OF SCIENCE. RANDOMISED CONTROL TRIALS AND QUASI-EXPERIMENTAL STUDIES EXAMINING PREGNANCY YOGA AND REPORTING ON EFFECT WILL BE INCLUDED. TITLES, ABSTRACTS AND FULL ARTICLES WILL BE SCREENED BY TWO INVESTIGATORS INDEPENDENTLY TO IDENTIFY ELIGIBLE STUDIES. THE COCHRANE COLLABORATION'S RISK OF BIAS ASSESSMENT TOOL WILL BE USED TO ASSESS STUDY QUALITY. QUALITY OF THE EVIDENCE WILL BE EVALUATED USING THE GRADE CRITERIA. A STANDARDISED DATA EXTRACTION FORM WILL BE USED TO EXTRACT DATA. EFFECT SIZES WILL BE ESTIMATED USING MEAN DIFFERENCES FOR CONTINUOUS OUTCOMES, AND RELATIVE RISKS FOR DICHOTOMOUS OUTCOME. WHERE POSSIBLE, POOLING OF EFFECT ESTIMATES WILL BE DONE USING A RANDOM EFFECT MODEL. THE OUTCOMES OF INTEREST ARE QUALITY OF LIFE, STRESS, ANXIETY, DEPRESSION, MODE OF BIRTH, LABOUR DURATION AND PAIN MANAGEMENT IN LABOUR. DISCUSSION: THIS REVIEW WILL SYNTHESISE THE BEST AVAILABLE EVIDENCE ON THE EFFECTIVENESS OF YOGA DURING PREGNANCY AND PROVIDE VALUABLE HIGH-QUALITY INFORMATION FOR CLINICIANS AND HEALTH POLICYMAKERS. FINDINGS WILL BE DISSEMINATED THROUGH PUBLICATION IN A PEER-REVIEWED JOURNAL AND PRESENTATION AT RELEVANT CONFERENCE PROCEEDINGS. THE REVIEW WILL MAKE RECOMMENDATIONS FOR THE APPROPRIATE VOLUME, INTENSITY AND TYPE OF PREGNANCY YOGA FOR MAXIMUM EFFECT AND MAY HAVE IMPLICATIONS FOR POLICY AND PRACTICE RELATING TO PREGNANCY YOGA AS AN INTERVENTION. REGISTRATION: PROSPERO, CRD42019119916. REGISTERED ON 11TH JANUARY 2019. 2019 16 1820 41 PROTOCOL FOR A RANDOMIZED CONTROLLED STUDY OF IYENGAR YOGA FOR YOUTH WITH IRRITABLE BOWEL SYNDROME. INTRODUCTION: IRRITABLE BOWEL SYNDROME AFFECTS AS MANY AS 14% OF HIGH SCHOOL-AGED STUDENTS. SYMPTOMS INCLUDE DISCOMFORT IN THE ABDOMEN, ALONG WITH DIARRHEA AND/OR CONSTIPATION AND OTHER GASTROENTEROLOGICAL SYMPTOMS THAT CAN SIGNIFICANTLY IMPACT QUALITY OF LIFE AND DAILY FUNCTIONING. EMOTIONAL STRESS APPEARS TO EXACERBATE IRRITABLE BOWEL SYNDROME SYMPTOMS SUGGESTING THAT MIND-BODY INTERVENTIONS REDUCING AROUSAL MAY PROVE BENEFICIAL. FOR MANY SUFFERERS, SYMPTOMS CAN BE TRACED TO CHILDHOOD AND ADOLESCENCE, MAKING THE EARLY MANIFESTATION OF IRRITABLE BOWEL SYNDROME IMPORTANT TO UNDERSTAND. THE CURRENT STUDY WILL FOCUS ON YOUNG PEOPLE AGED 14-26 YEARS WITH IRRITABLE BOWEL SYNDROME. THE STUDY WILL TEST THE POTENTIAL BENEFITS OF IYENGAR YOGA ON CLINICAL SYMPTOMS, PSYCHOSPIRITUAL FUNCTIONING AND VISCERAL SENSITIVITY. YOGA IS THOUGHT TO BRING PHYSICAL, PSYCHOLOGICAL AND SPIRITUAL BENEFITS TO PRACTITIONERS AND HAS BEEN ASSOCIATED WITH REDUCED STRESS AND PAIN. THROUGH ITS FOCUS ON RESTORATION AND USE OF PROPS, IYENGAR YOGA IS ESPECIALLY DESIGNED TO DECREASE AROUSAL AND PROMOTE PSYCHOSPIRITUAL RESOURCES IN PHYSICALLY COMPROMISED INDIVIDUALS. AN EXTENSIVE AND STANDARDIZED TEACHER-TRAINING PROGRAM SUPPORT IYENGAR YOGA'S RELIABILITY AND SAFETY. IT IS HYPOTHESIZED THAT YOGA WILL BE FEASIBLE WITH LESS THAN 20% ATTRITION; AND THE YOGA GROUP WILL DEMONSTRATE SIGNIFICANTLY IMPROVED OUTCOMES COMPARED TO CONTROLS, WITH PHYSIOLOGICAL AND PSYCHOSPIRITUAL MECHANISMS CONTRIBUTING TO IMPROVEMENTS. METHODS/DESIGN: SIXTY IRRITABLE BOWEL SYNDROME PATIENTS AGED 14-26 WILL BE RANDOMLY ASSIGNED TO A STANDARDIZED 6-WEEK TWICE WEEKLY IYENGAR YOGA GROUP-BASED PROGRAM OR A WAIT-LIST USUAL CARE CONTROL GROUP. THE GROUPS WILL BE COMPARED ON THE PRIMARY CLINICAL OUTCOMES OF IRRITABLE BOWEL SYNDROME SYMPTOMS, QUALITY OF LIFE AND GLOBAL IMPROVEMENT AT POST-TREATMENT AND 2-MONTH FOLLOW-UP. SECONDARY OUTCOMES WILL INCLUDE VISCERAL PAIN SENSITIVITY ASSESSED WITH A STANDARDIZED LABORATORY TASK (WATER LOAD TASK), FUNCTIONAL DISABILITY AND PSYCHOSPIRITUAL VARIABLES INCLUDING CATASTROPHIZING, SELF-EFFICACY, MOOD, ACCEPTANCE AND MINDFULNESS. MECHANISMS OF ACTION INVOLVED IN THE PROPOSED BENEFICIAL EFFECTS OF YOGA UPON CLINICAL OUTCOMES WILL BE EXPLORED, AND INCLUDE THE MEDIATING EFFECTS OF VISCERAL SENSITIVITY, INCREASED PSYCHOSPIRITUAL RESOURCES, REGULATED AUTONOMIC NERVOUS SYSTEM RESPONSES AND REGULATED HORMONAL STRESS RESPONSE ASSESSED VIA SALIVARY CORTISOL. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01107977. 2011 17 2824 45 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183. 2016 18 1161 36 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 19 2019 28 SYNCHRONOUS TELEHEALTH YOGA AND COGNITIVE PROCESSING GROUP THERAPIES FOR WOMEN VETERANS WITH POSTTRAUMATIC STRESS DISORDER: A MULTISITE RANDOMIZED CONTROLLED TRIAL ADAPTED FOR COVID-19. BACKGROUND: PROVIDING CARE OVER TELEHEALTH GREW SLOWLY UNTIL THE COVID-19 PANDEMIC. SINCE THE ONSET OF THE COVID-19 PANDEMIC, PROVIDING MENTAL HEALTH CARE WAS READILY ADAPTED TO VIRTUAL MEANS; HOWEVER, CLINICAL TRIAL RESEARCH IS NASCENT IN ADAPTING METHODS AND PROCEDURES TO THE VIRTUAL WORLD. METHODS: WE PRESENT PROTOCOL MODIFICATIONS TO PIVOT A MULTISITE RANDOMIZED CONTROLLED TRIAL STUDY, CONDUCTED AT SOUTHEASTERN AND PACIFIC NORTHWESTERN VETERANS AFFAIRS HEALTH CARE SYSTEMS, FROM BEING CONDUCTED IN-PERSON TO VIRTUALLY, FOLLOWING THE ONSET OF THE COVID-19 PANDEMIC. WE MEASURED OUTCOMES OF POSTTRAUMATIC STRESS DISORDER (PTSD) SYMPTOMS AND PSYCHOPHYSIOLOGICAL MARKERS OF STRESS AMONG FEMALE VETERANS WITH PTSD SECONDARY TO MILITARY SEXUAL TRAUMA. WE COLLECTED QUALITATIVE DATA ABOUT PROVIDER AND PARTICIPANT EXPERIENCES WITH TELEHEALTH. RESULTS: ACROSS SITES, 200 PARTICIPANTS WERE CONSENTED (48 VIRTUALLY), 132 WERE RANDOMIZED (28 TO VIRTUAL GROUPS), AND 117 COMPLETED DATA COLLECTION AND TREATMENT (69 COMPLETED ALL OR SOME DATA COLLECTION OR TREATMENT VIRTUALLY). CONCLUSIONS: THE PIVOTS MADE FOR THIS STUDY WERE IN RESPONSE TO THE COVID-19 PANDEMIC AND OFFER INNOVATIVE PROCEDURES LEVERAGING TECHNOLOGY AND CONTRIBUTING TO THE BROADER LANDSCAPE OF CONDUCTING RESEARCH VIRTUALLY. CLINICAL TRIALS NUMBER: NCT02640690. 2022 20 1495 42 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE. 2016