1 2008 190 STUDY PROTOCOL FOR YOGA-BASED LIFESTYLE INTERVENTION FOR HEALTHY AGEING PHENOTYPE IN THE OLDER ADULTS (YHAP): A TWO-ARMED, WAITLIST RANDOMISED CONTROLLED TRIAL WITH MULTIPLE PRIMARY OUTCOMES. INTRODUCTION: THE CONCEPTUALISATION OF HEALTHY AGEING PHENOTYPE (HAP) AND THE AVAILABILITY OF A TENTATIVE PANEL FOR HAP BIOMARKERS RAISE THE NEED TO TEST THE EFFICACY OF POTENTIAL INTERVENTIONS TO PROMOTE HEALTH IN OLDER ADULTS. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 24-WEEK PROGRAMME TO EXPLORE THE HOLISTIC INFLUENCE OF THE YOGA-BASED INTERVENTION ON THE (BIO)MARKERS OF HAP. METHODS AND ANALYSIS: THE STUDY IS A TWO-ARMED, RANDOMISED WAITLIST CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS AND MULTIPLE PRIMARY OUTCOMES. WE AIM TO RECRUIT 250 SUBJECTS, AGED 60-80 YEARS FROM THE RESIDENTIAL COMMUNITIES AND OLD AGE CLUBS IN BANGALORE CITY, INDIA, WHO WILL UNDERGO RANDOMISATION INTO INTERVENTION OR CONTROL ARMS (1:1). THE INTERVENTION WILL INCLUDE A YOGA-BASED PROGRAMME TAILORED FOR THE OLDER ADULTS, 1 HOUR PER DAY FOR 6 DAYS A WEEK, SPREAD FOR 24 WEEKS. DATA WOULD BE COLLECTED AT THE BASELINE AND POST-INTERVENTION, THE 24TH WEEK. THE MULTIPLE PRIMARY OUTCOMES OF THE STUDY ARE THE (BIO)MARKERS OF HAP: GLYCATED HAEMOGLOBIN, LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C), SYSTOLIC BLOOD PRESSURE, AND FORCED EXPIRATORY VOLUME IN 1 S FOR PHYSIOLOGICAL AND METABOLIC HEALTH; DIGIT SYMBOL SUBSTITUTION TEST, TRAIL MAKING TESTS A AND B FOR COGNITION; HAND GRIP STRENGTH AND GAIT SPEED FOR PHYSICAL CAPABILITY; LONELINESS FOR SOCIAL WELL-BEING AND WHO QUALITY OF LIFE INSTRUMENT-SHORT FORM FOR QUALITY OF LIFE. THE SECONDARY OUTCOMES INCLUDE INFLAMMATORY MARKERS, TUMOUR NECROSIS FACTOR-ALPHA RECEPTOR II, C REACTIVE PROTEIN, INTERLEUKIN 6 AND SERUM KLOTHO LEVELS. ANALYSES WILL BE BY INTENTION-TO-TREAT AND THE HOLISTIC IMPACT OF YOGA ON HAP WILL BE ASSESSED USING GLOBAL STATISTICAL TEST. ETHICS AND DISSEMINATION: THE STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA UNIVERSITY, BANGALORE (ID: RES/IEC-SVYASA/143/2019). WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
2 2861  59 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
3  888  71 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	

4 1854  48 RANDOMISED CONTROLLED TRIAL OF A 12 WEEK YOGA INTERVENTION ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-CARDIAC REHABILITATION PATIENTS. BACKGROUND: NEGATIVE AFFECTIVE STATES SUCH AS ANXIETY, DEPRESSION AND STRESS ARE SIGNIFICANT RISK FACTORS FOR CARDIOVASCULAR DISEASE, PARTICULARLY IN CARDIAC AND POST-CARDIAC REHABILITATION POPULATIONS.YOGA IS A BALANCED PRACTICE OF PHYSICAL EXERCISE, BREATHING CONTROL AND MEDITATION THAT CAN REDUCE PSYCHOSOCIAL SYMPTOMS AS WELL AS IMPROVE CARDIOVASCULAR AND COGNITIVE FUNCTION. IT HAS THE POTENTIAL TO POSITIVELY AFFECT MULTIPLE DISEASE PATHWAYS AND MAY PROVE TO BE A PRACTICAL ADJUNCT TO CARDIAC REHABILITATION IN FURTHER REDUCING CARDIAC RISK FACTORS AS WELL AS IMPROVING SELF-EFFICACY AND POST-CARDIAC REHABILITATION ADHERENCE TO HEALTHY LIFESTYLE BEHAVIOURS. METHOD AND DESIGN: THIS IS A PARALLEL ARM, MULTI-CENTRE, RANDOMISED CONTROLLED TRIAL THAT WILL ASSESS THE OUTCOMES OF POST- PHASE 2 CARDIAC REHABILITATION PATIENTS ASSIGNED TO A YOGA INTERVENTION IN COMPARISON TO A NO-TREATMENT WAIT-LIST CONTROL GROUP. PARTICIPANTS RANDOMISED TO THE YOGA GROUP WILL ENGAGE IN A 12 WEEK YOGA PROGRAM COMPRISING OF TWO GROUP BASED SESSIONS AND ONE SELF-ADMINISTERED HOME SESSION EACH WEEK. GROUP BASED SESSIONS WILL BE LED BY AN EXPERIENCED YOGA INSTRUCTOR. THIS WILL INVOLVE TEACHING BEGINNER STUDENTS A HATHA YOGA SEQUENCE THAT INCORPORATES ASANA (POSES AND POSTURES), PRANAYAMA (BREATHING CONTROL) AND MEDITATION. THE PRIMARY OUTCOMES OF THIS STUDY ARE NEGATIVE AFFECTIVE STATES OF ANXIETY, DEPRESSION AND STRESS ASSESSED USING THE DEPRESSION ANXIETY STRESS SCALE. SECONDARY OUTCOMES INCLUDE MEASURES OF QUALITY OF LIFE, AND CARDIOVASCULAR AND COGNITIVE FUNCTION. THE CARDIOVASCULAR OUTCOMES WILL INCLUDE BLOOD PRESSURE, HEART RATE, HEART RATE VARIABILITY, PULSE WAVE VELOCITY, CAROTID INTIMA MEDIA THICKNESS MEASUREMENTS, LIPID/GLUCOSE PROFILES AND C-REACTIVE PROTEIN ASSAYS. ASSESSMENTS WILL BE CONDUCTED PRIOR TO (WEEK 0), MID-WAY THROUGH (WEEK 6) AND FOLLOWING THE INTERVENTION PERIOD (WEEK 12) AS WELL AS AT A FOUR WEEK FOLLOW-UP (WEEK 16). DISCUSSION: THIS STUDY WILL DETERMINE THE EFFECT OF YOGA PRACTICE ON NEGATIVE AFFECTIVE STATES, CARDIOVASCULAR AND COGNITIVE FUNCTION IN POST-PHASE 2 CARDIAC REHABILITATION PATIENTS. THE FINDINGS MAY PROVIDE EVIDENCE TO INCORPORATE YOGA INTO STANDARDISED CARDIAC REHABILITATION PROGRAMS AS A PRACTICAL ADJUNCT TO IMPROVE THE MANAGEMENT OF PSYCHOSOCIAL SYMPTOMS ASSOCIATED WITH CARDIOVASCULAR EVENTS IN ADDITION TO IMPROVING PATIENTS' COGNITIVE AND CARDIOVASCULAR FUNCTIONS. TRIAL REGISTRATION: ACTRN12612000358842.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
5 2764  61 YOGA PROGRAMME FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH RISK PEOPLE IN INDIA: A MULTICENTRE FEASIBILITY RANDOMISED CONTROLLED TRIAL PROTOCOL. INTRODUCTION: A HUGE POPULATION IN INDIA IS AT HIGH RISK OF TYPE-2 DIABETES (T2DM). PHYSICAL ACTIVITY AND A HEALTHY DIET (HEALTHY LIFESTYLE) IMPROVE BLOOD GLUCOSE LEVELS IN PEOPLE AT HIGH RISK OF T2DM. HOWEVER, AN UNHEALTHY LIFESTYLE IS COMMON AMONG INDIANS. YOGA COVERS PHYSICAL ACTIVITY AND A HEALTHY DIET AND CAN HELP TO PREVENT T2DM. THE RESEARCH QUESTION TO BE ADDRESSED BY THE MAIN RANDOMISED CONTROLLED TRIAL (RCT) IS WHETHER A YOGA PROGRAMME FOR T2DM PREVENTION (YOGA-DP) IS EFFECTIVE IN PREVENTING T2DM AMONG HIGH RISK PEOPLE IN INDIA AS COMPARED WITH ENHANCED STANDARD CARE. IN THIS CURRENT STUDY, WE ARE DETERMINING THE FEASIBILITY OF UNDERTAKING THE MAIN RCT. INTERVENTION: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAMME. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES) AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. METHODS AND ANALYSIS: THIS IS A MULTICENTRE, TWO-ARM, PARALLEL-GROUP, FEASIBILITY RCT WITH BLINDED OUTCOME ASSESSMENT AND INTEGRATED MIXED-METHODS PROCESS EVALUATION. ELIGIBLE PARTICIPANTS SHOULD BE AGED 18-74 YEARS, AT HIGH RISK OF T2DM (FASTING PLASMA GLUCOSE LEVEL 5.6-6.9 MMOL/L) AND SAFE TO PARTICIPATE IN PHYSICAL ACTIVITIES. AT LEAST 64 PARTICIPANTS WILL BE RANDOMISED TO INTERVENTION OR CONTROL GROUP WITH FINAL FOLLOW-UP AT 6 MONTHS. IMPORTANT PARAMETERS, NEEDED TO DESIGN THE MAIN RCT, WILL BE ESTIMATED, SUCH AS SD OF THE OUTCOME MEASURE (FASTING PLASMA GLUCOSE LEVEL AT 6-MONTH FOLLOW-UP), RECRUITMENT, INTERVENTION ADHERENCE, FOLLOW-UP, POTENTIAL CONTAMINATION AND TIME NEEDED TO CONDUCT THE STUDY. SEMISTRUCTURED QUALITATIVE INTERVIEWS WILL BE CONDUCTED WITH UP TO 20-30 PARTICIPANTS, A SAMPLE OF THOSE DECLINING TO PARTICIPATE, FOUR YOGA-DP INSTRUCTORS AND AROUND EIGHT STUDY STAFF TO EXPLORE THEIR PERCEPTIONS AND EXPERIENCES OF TAKING PART IN THE STUDY AND OF THE INTERVENTION, REASONS BEHIND NON-PARTICIPATION, EXPERIENCES OF DELIVERING THE INTERVENTION AND RUNNING THE STUDY, RESPECTIVELY. ETHICS AND DISSEMINATION: ETHICS APPROVAL HAS BEEN OBTAINED FROM THE FOLLOWING RESEARCH ETHICS COMMITTEES: FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITY OF NOTTINGHAM (UK); CENTRE FOR CHRONIC DISEASE CONTROL (CCDC, INDIA); BAPU NATURE CURE HOSPITAL AND YOGASHRAM (BNCHY, INDIA) AND SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA (S-VYASA, INDIA). THE RESULTS WILL BE WIDELY DISSEMINATED AMONG KEY STAKEHOLDERS THROUGH VARIOUS AVENUES. TRIAL REGISTRATION NUMBER: CTRI/2019/05/018893.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
6 1370  42 IMPACT OF A STRUCTURED YOGA PROGRAM ON BLOOD PRESSURE REDUCTION AMONG HYPERTENSIVE PATIENTS: STUDY PROTOCOL FOR A PRAGMATIC RANDOMIZED MULTICENTER TRIAL IN PRIMARY HEALTH CARE SETTINGS IN NEPAL. BACKGROUND: HYPERTENSION CONTROL REMAINS A MAJOR GLOBAL CHALLENGE. THE BEHAVIORAL APPROACHES RECOMMENDED FOR BLOOD PRESSURE REDUCTION ARE STRESS REDUCTION, INCREASED EXERCISE AND HEALTHY DIETARY HABITS. SOME STUDY FINDINGS SUGGEST THAT YOGA HAS A BENEFICIAL EFFECT IN REDUCING BLOOD PRESSURE. HOWEVER, THE ROLE OF YOGA ON BLOOD PRESSURE HAS RECEIVED LITTLE ATTENTION IN EXISTING HEALTH CARE PRACTICES IN DEVELOPING COUNTRIES. THIS STUDY WILL BE CONDUCTED IN PRIMARY HEALTH CARE FACILITIES IN NEPAL TO ASSESS THE EFFECTIVENESS OF A PRAGMATIC YOGA INTERVENTION TO COMPLEMENT STANDARD PRACTICE IN FURTHER REDUCING BLOOD PRESSURE. METHODS: THIS WILL BE MULTICENTRIC, TWO ARMS, RANDOMIZED, NONBLINDED, PRAGMATIC TRIAL. IT WILL BE CONDUCTED IN SEVEN DISTRICT AYURVEDA HEALTH CENTERS (DAHCS) IN NEPAL BETWEEN JULY 2017 AND JUNE 2018. THE STUDY PARTICIPANTS WILL CONSIST OF HYPERTENSIVE PATIENTS WITH OR WITHOUT ANTIHYPERTENSIVE MEDICATION ATTENDING TO THE OUTPATIENT DEPARTMENT (OPD). ONE HUNDRED AND FORTY PARTICIPANTS WILL BE RANDOMIZED TO TREATMENT OR CONTROL GROUPS BY USING A STRATIFIED BLOCK RANDOMIZATION. AT THE STUDY SITE, THE TREATMENT ARM PARTICIPANTS WILL RECEIVE AN INTERVENTION CONSISTING OF FIVE DAYS OF STRUCTURED YOGA TRAINING AND PRACTICE OF THE SAME PACKAGE AT HOME WITH A RECOMMENDATION OF FIVE DAYS A WEEK FOR THE FOLLOWING 90 DAYS. BOTH THE INTERVENTION AND CONTROL GROUPS WILL RECEIVE TWO HOURS OF HEALTH EDUCATION ON LIFESTYLE MODIFICATIONS. THE PRIMARY OUTCOME OF THIS TRIAL WILL BE THE CHANGE IN SYSTOLIC BLOOD PRESSURE AND IT WILL BE ASSESSED AFTER 90 DAYS OF THE INTERVENTION. DISCUSSION: THIS STUDY WILL ESTABLISH THE EXTENT TO WHICH A YOGA INTERVENTION PACKAGE CAN HELP REDUCE BLOOD PRESSURE IN HYPERTENSIVE PATIENTS. IF PROVEN EFFECTIVE, STUDY FINDINGS MAY BE USED TO RECOMMEND THE GOVERNING BODIES AND OTHER STAKEHOLDERS FOR THE INTEGRATION OF YOGA IN THE NATIONAL HEALTHCARE SYSTEM FOR THE TREATMENT AND CONTROL OF HYPERTENSION. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRY- INDIA (CTRI); CTRI REG. NO- CTRI/2017/02/007822 . REGISTERED ON 10/02/2017.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
7 1093  75 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
8 2834  43 YOGA'S EFFECT ON INFLAMMATORY BIOMARKERS AND METABOLIC RISK FACTORS IN A HIGH RISK POPULATION - A CONTROLLED TRIAL IN PRIMARY CARE. BACKGROUND: YOGA CAN REDUCE BLOOD PRESSURE AND HAS ALSO BEEN SUGGESTED TO REDUCE INFLAMMATORY BIOMARKERS AND METABOLIC RISK FACTORS FOR CARDIOVASCULAR DISEASES (CVDS). WE AIMED TO ASSESS THE BENEFIT OF TWO YOGA INTERVENTIONS ON INFLAMMATORY BIOMARKERS AND METABOLIC RISK FACTORS IN A HIGH RISK POPULATION IN PRIMARY CARE. METHODS: ADULT PATIENTS FROM A HEALTH CARE CENTER IN SWEDEN, WITH DIAGNOSED HYPERTENSION, WERE INVITED TO UNDERGO A BASELINE CHECK AT THE HEALTH CARE CENTER. BASELINE CHECK INCLUDED STANDARDIZED BLOOD PRESSURE MEASUREMENT, BMI AND WEIGHT CIRCUMFERENCE MEASUREMENTS, BLOOD SAMPLING (HS-CRP, IL-6, FP-GLUCOSE, HBA1C, CHOLESTEROL, TG, LDL AND HDL) AND A QUESTIONNAIRE ON SELF-RATED QUALITY OF LIFE (WHOQOL-BREF). THERE WERE THREE GROUPS: 1) YOGA CLASS WITH YOGA INSTRUCTOR; 2) YOGA AT HOME; AND 3) A CONTROL GROUP. IN TOTAL, 83 PATIENTS WERE INCLUDED AND MATCHED AT THE GROUP LEVEL FOR SYSTOLIC BLOOD PRESSURE. A MAJORITY OF THE PATIENTS (92 %) WERE ON ANTIHYPERTENSIVE MEDICATION, WHICH THEY WERE REQUESTED NOT TO CHANGE DURING THE STUDY. AFTER 12 WEEKS OF INTERVENTION, THE ASSESSMENTS WERE PERFORMED AGAIN. RESULTS: WE RECORDED NO EVIDENCE THAT YOGA ALTERED INFLAMMATORY BIOMARKERS OR METABOLIC RISK FACTORS IN OUR STUDY POPULATION. A TOTAL OF 49 PARTICIPANTS (59 %) MET THE CRITERIA FOR METABOLIC SYNDROME. CONCLUSION: THE YOGA INTERVENTIONS PERFORMED IN OUR STUDY DID NOT AFFECT INFLAMMATORY BIOMARKERS OR METABOLIC RISK FACTORS ASSOCIATED WITH CVD IN THE STUDY POPULATION OF PRIMARY CARE PATIENTS WITH HYPERTENSION. FURTHER RANDOMIZED TRIALS ARE NEEDED TO ELUCIDATE THE EFFECTS OF YOGA ON CVD RISK FACTORS IN THIS PARTICULAR GROUP. TRAIL REGISTRATION: NCT01302535 , FEBRUARY 22, 2011.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
9 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
10 2353  31 UTILIZATION OF 3-MONTH YOGA PROGRAM FOR ADULTS AT HIGH RISK FOR TYPE 2 DIABETES: A PILOT STUDY. VARIOUS MODES OF PHYSICAL ACTIVITY, COMBINED WITH DIETING, HAVE BEEN WIDELY RECOMMENDED TO PREVENT OR DELAY TYPE 2 DIABETES. AMONG THESE, YOGA HOLDS PROMISE FOR REDUCING RISK FACTORS FOR TYPE 2 DIABETES BY PROMOTING WEIGHT LOSS, IMPROVING GLUCOSE LEVELS AND REDUCING BLOOD PRESSURE AND LIPID LEVELS. THIS PILOT STUDY AIMED TO ASSESS THE FEASIBILITY OF IMPLEMENTING A 12-WEEK YOGA PROGRAM AMONG ADULTS AT HIGH RISK FOR TYPE 2 DIABETES. TWENTY-THREE ADULTS (19 WHITES AND 4 NON-WHITES) WERE RANDOMLY ASSIGNED TO THE YOGA INTERVENTION GROUP OR THE EDUCATIONAL GROUP. THE YOGA GROUP PARTICIPATED IN A 3-MONTH YOGA INTERVENTION WITH SESSIONS TWICE PER WEEK AND THE EDUCATIONAL GROUP RECEIVED GENERAL HEALTH EDUCATIONAL MATERIALS EVERY 2 WEEKS. ALL PARTICIPANTS COMPLETED QUESTIONNAIRES AND HAD BLOOD TESTS AT BASELINE AND AT THE END OF 3 MONTHS. EFFECT SIZES WERE REPORTED TO SUMMARIZE THE EFFICACY OF THE INTERVENTION. ALL PARTICIPANTS ASSIGNED TO THE YOGA INTERVENTION COMPLETED THE YOGA PROGRAM WITHOUT COMPLICATION AND EXPRESSED HIGH SATISFACTION WITH THE PROGRAM (99.2%). THEIR YOGA SESSION ATTENDANCE RANGED FROM 58.3 TO 100%. COMPARED WITH THE EDUCATION GROUP, THE YOGA GROUP EXPERIENCED IMPROVEMENTS IN WEIGHT, BLOOD PRESSURE, INSULIN, TRIGLYCERIDES AND EXERCISE SELF-EFFICACY INDICATED BY SMALL TO LARGE EFFECT SIZES. THIS PRELIMINARY STUDY INDICATES THAT A YOGA PROGRAM WOULD BE A POSSIBLE RISK REDUCTION OPTION FOR ADULTS AT HIGH RISK FOR TYPE 2 DIABETES. IN ADDITION, YOGA HOLDS PROMISE AS AN APPROACH TO REDUCING CARDIOMETABOLIC RISK FACTORS AND INCREASING EXERCISE SELF-EFFICACY FOR THIS GROUP.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
11 1242  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
12 1161  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
13  175  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
14 2394  42 YOGA AND BREATHING TECHNIQUE TRAINING IN PATIENTS WITH HEART FAILURE AND PRESERVED EJECTION FRACTION: STUDY PROTOCOL FOR A RANDOMIZED CLINICAL TRIAL. BACKGROUND: CURRENT THERAPIES FOR HEART FAILURE (HF) ARE FOLLOWED BY STRATEGIES TO IMPROVE QUALITY OF LIFE AND EXERCISE TOLERANCE, BESIDES REDUCING MORBIDITY AND MORTALITY. SOME HF PATIENTS PRESENT CHANGES IN THE MUSCULOSKELETAL SYSTEM AND INSPIRATORY MUSCLE WEAKNESS, WHICH MAY BE RESTORED BY INSPIRATORY MUSCLE TRAINING, THUS INCREASING RESPIRATORY MUSCLE STRENGTH AND ENDURANCE, MAXIMAL OXYGEN UPTAKE (VO2), FUNCTIONAL CAPACITY, RESPIRATORY RESPONSES TO EXERCISE, AND QUALITY OF LIFE. YOGA THERAPIES HAVE BEEN SHOWN TO IMPROVE QUALITY OF LIFE, INFLAMMATORY MARKERS, AND PEAK VO2 MOSTLY IN HF PATIENTS WITH A REDUCED EJECTION FRACTION. HOWEVER, THE EFFECT OF DIFFERENT YOGA BREATHING TECHNIQUES IN PATIENTS SHOWING HF WITH A PRESERVED EJECTION FRACTION (HFPEF) REMAIN TO BE ASSESSED. METHODS/DESIGN: A PROBE (PROSPECTIVE RANDOMIZED OPEN BLINDED END-POINT) PARALLEL-GROUP TRIAL WILL BE CONDUCTED AT TWO SPECIALIZED HF CLINICS. ADULT PATIENTS PREVIOUSLY DIAGNOSED WITH HFPEF WILL BE INCLUDED. AFTER SIGNING INFORMED CONSENT AND PERFORMING A PRE-TEST INTERVENTION, PATIENTS WILL BE RANDOMIZED INTO THREE GROUPS AND PROVIDED WITH EITHER (1) ACTIVE YOGA BREATHING TECHNIQUES; (2) PASSIVE YOGA BREATHING TECHNIQUES (PRANAYAMA); OR AND (3) CONTROL (STANDARD PHARMACOLOGICAL TREATMENT). FOLLOW-UP WILL LAST 8 WEEKS (16 SESSIONS). THE POST-INTERVENTION TESTS WILL BE PERFORMED AT THE END OF THE INTERVENTION PERIOD FOR ANALYSIS OF OUTCOMES. INTERVENTIONS WILL OCCUR CONTINUOUSLY ACCORDING TO PATIENTS' ENROLLMENT. THE MAIN OUTCOME IS RESPIRATORY MUSCULAR RESISTANCE. A TOTAL OF 33 ENROLLED PATIENTS ARE EXPECTED. THE PRESENT PROTOCOL FOLLOWED THE SPIRIT GUIDELINES AND FULFILLED THE SPIRIT CHECKLIST. DISCUSSION: THIS TRIAL IS PROBABLY THE FIRST TO ASSESS THE EFFECTS OF A NON-PHARMACOLOGICAL INTERVENTION, NAMELY YOGA AND SPECIFIC BREATHING TECHNIQUES, TO IMPROVE CARDIORESPIRATORY FUNCTION, AUTONOMIC SYSTEM, AND QUALITY OF LIFE IN PATIENTS WITH HFPEF. TRIAL REGISTRATION: REBEC IDENTIFIER: RBR-64MBNX (AUGUST 19, 2012). CLINICAL TRIALS REGISTER: NCT03028168 . REGISTERED ON 16 JANUARY 2017).	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
15 1106  36 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
16 2117  44 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
17 1707  34 PATTERNS OF YOGA PRACTICE AND PHYSICAL ACTIVITY FOLLOWING A YOGA INTERVENTION FOR ADULTS WITH OR AT RISK FOR TYPE 2 DIABETES. BACKGROUND: THE CURRENT STUDY DESCRIBED PATTERNS OF YOGA PRACTICE AND EXAMINED DIFFERENCES IN PHYSICAL ACTIVITY OVER TIME BETWEEN INDIVIDUALS WITH OR AT RISK FOR TYPE 2 DIABETES WHO COMPLETED AN 8-WEEK YOGA INTERVENTION COMPARED WITH CONTROLS. METHODS: A LONGITUDINAL COMPARATIVE DESIGN MEASURED THE EFFECT OF A YOGA INTERVENTION ON YOGA PRACTICE AND PHYSICAL ACTIVITY, USING DATA AT BASELINE AND POSTINTERVENTION MONTHS 3, 6, AND 15. RESULTS: DISPARATE PATTERNS OF YOGA PRACTICE OCCURRED BETWEEN INTERVENTION AND CONTROL PARTICIPANTS OVER TIME, BUT THE SUBJECTIVE DEFINITION OF YOGA PRACTICE LIMITS INTERPRETATION. MULTILEVEL MODEL ESTIMATES INDICATED THAT TREATMENT GROUP DID NOT HAVE A SIGNIFICANT INFLUENCE IN THE RATE OF CHANGE IN PHYSICAL ACTIVITY OVER THE STUDY PERIOD. WHILE AGE AND EDUCATION WERE NOT SIGNIFICANT INDIVIDUAL PREDICTORS, THE INCLUSION OF THESE VARIABLES IN THE MODEL DID IMPROVE FIT. CONCLUSIONS: FINDINGS INDICATE THAT AN 8-WEEK YOGA INTERVENTION HAD LITTLE EFFECT ON PHYSICAL ACTIVITY OVER TIME. FURTHER RESEARCH IS NECESSARY TO EXPLORE THE INFLUENCE OF YOGA ON BEHAVIORAL HEALTH OUTCOMES AMONG INDIVIDUALS WITH OR AT RISK FOR TYPE 2 DIABETES.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
18 2187  48 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
19 1552  37 LIFESTYLE MODIFICATION IN BLOOD PRESSURE STUDY II (LIMBS): STUDY PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL ASSESSING THE EFFICACY OF A 24 WEEK STRUCTURED YOGA PROGRAM VERSUS LIFESTYLE MODIFICATION ON BLOOD PRESSURE REDUCTION. HYPERTENSION IS A MAJOR PUBLIC HEALTH ISSUE AFFECTING 68 MILLION ADULTS IN THE UNITED STATES. LIFESTYLE MODIFICATIONS INCLUDING COMPLEMENTARY THERAPIES SUCH AS THE MOVEMENT BASED MIND BODY PRACTICE OF YOGA HAVE BECOME INCREASINGLY POPULAR IN THE UNITED STATES AND HAVE BEEN CONSIDERED AS A POTENTIAL ALTERNATIVE TO MEDICATION IN BLOOD PRESSURE REDUCTION. WE COMPLETED A PILOT STUDY IN 2009 WHICH SHOWED MEANINGFUL DECREASES IN 24-HOUR AMBULATORY BLOOD PRESSURE READINGS AFTER A 12 WEEK PERIOD OF YOGA PARTICIPATION. BASED ON DATA FROM OUR PILOT STUDY WE ARE NOW COMPLETING THE LIFESTYLE MODIFICATION AND BLOOD PRESSURE STUDY (LIMBS II) WHICH IS A PHASE 2 RANDOMIZED CONTROLLED TRIAL DESIGNED TO DETERMINE THE EFFECTS OF YOGA THERAPY AND ENHANCED LIFESTYLE MODIFICATION ON LOWERING BLOOD PRESSURE IN PRE-HYPERTENSIVE AND STAGE 1 HYPERTENSIVE SUBJECTS. USING 24-HOUR AMBULATORY BLOOD PRESSURE MONITORING, LIMBS II AIMS TO COMPARE THE EFFECTS ON BLOOD PRESSURE REDUCTION IN SUBJECTS RANDOMIZED FOR 24 WEEKS TO ONE OF THE THREE FOLLOWING GROUPS: YOGA THERAPY VERSUS BLOOD PRESSURE EDUCATION PROGRAM (SODIUM RESTRICTION AND WALKING PROGRAM) VERSUS A COMBINATION PROGRAM THAT INVOLVES COMPONENTS OF BOTH GROUPS. LIMBS II WILL ALSO EXAMINE THE IMPACT THAT CHANGES IN BLOOD PRESSURE HAVE ON CEREBRAL BLOOD FLOW. IF SUCCESSFUL, THE LIMBS STUDY WILL DETERMINE IF YOGA THERAPY COMBINED WITH ENHANCED LIFESTYLE MODIFICATION WILL RESULT IN CLINICALLY MEANINGFUL DECREASES IN BLOOD PRESSURE AND THUS CAN BE IMPLEMENTED AS AN ALTERNATIVE TO DRUG THERAPY FOR PATIENTS WITH PREHYPERTENSION AND STAGE 1 HYPERTENSION.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
20 1402  41 IMPACT OF YOGA ON BLOOD PRESSURE AND QUALITY OF LIFE IN PATIENTS WITH HYPERTENSION - A CONTROLLED TRIAL IN PRIMARY CARE, MATCHED FOR SYSTOLIC BLOOD PRESSURE. BACKGROUND: MEDICAL TREATMENT OF HYPERTENSION IS NOT ALWAYS SUFFICIENT TO ACHIEVE BLOOD PRESSURE CONTROL. DESPITE THIS, PREVIOUS STUDIES ON SUPPLEMENTARY THERAPIES, SUCH AS YOGA, ARE RELATIVELY FEW. WE INVESTIGATED THE EFFECTS OF TWO YOGA INTERVENTIONS ON BLOOD PRESSURE AND QUALITY OF LIFE IN PATIENTS IN PRIMARY HEALTH CARE DIAGNOSED WITH HYPERTENSION. METHODS: ADULT PATIENTS (AGE 20-80 YEARS) WITH DIAGNOSED HYPERTENSION WERE IDENTIFIED BY AN ELECTRONIC CHART SEARCH AT A PRIMARY HEALTH CARE CENTER IN SOUTHERN SWEDEN. IN TOTAL, 83 SUBJECTS WITH BLOOD PRESSURE VALUES OF 120-179/</=109 MMHG AT BASELINE WERE ENROLLED. AT BASELINE, THE PATIENTS UNDERWENT STANDARDIZED BLOOD PRESSURE MEASUREMENT AT THE HEALTH CARE CENTER AND THEY COMPLETED A QUESTIONNAIRE ON SELF-RATED QUALITY OF LIFE (WHOQOL-BREF). THERE WERE THREE GROUPS: 1) YOGA CLASS WITH YOGA INSTRUCTOR (N = 28); 2) YOGA AT HOME (N = 28); AND 3) A CONTROL GROUP (N = 27). THE PARTICIPANTS WERE MATCHED AT THE GROUP LEVEL FOR SYSTOLIC BLOOD PRESSURE. AFTER 12 WEEKS OF INTERVENTION, THE ASSESSMENTS WERE PERFORMED AGAIN. AT BASELINE A MAJORITY OF THE PATIENTS (92%) WERE ON ANTIHYPERTENSIVE MEDICATION, AND THE PATIENTS WERE REQUESTED NOT TO CHANGE THEIR MEDICATION DURING THE STUDY. RESULTS: THE YOGA CLASS GROUP SHOWED NO IMPROVEMENT IN BLOOD PRESSURE OR SELF-RATED QUALITY OF LIFE, WHILE IN THE YOGA AT HOME GROUP THERE WAS A DECLINE IN DIASTOLIC BLOOD PRESSURE OF 4.4 MMHG (P < 0.05) COMPARED TO THE CONTROL GROUP. MOREOVER, THE YOGA AT HOME GROUP SHOWED SIGNIFICANT IMPROVEMENT IN SELF-RATED QUALITY OF LIFE COMPARED TO THE CONTROL GROUP (P < 0.05). CONCLUSIONS: A SHORT YOGA PROGRAM FOR THE PATIENT TO PRACTICE AT HOME SEEMS TO HAVE AN ANTIHYPERTENSIVE EFFECT, AS WELL AS A POSITIVE EFFECT ON SELF-RATED QUALITY OF LIFE COMPARED TO CONTROLS. THIS IMPLIES THAT SIMPLE YOGA EXERCISES MAY BE USEFUL AS A SUPPLEMENTARY BLOOD PRESSURE THERAPY IN ADDITION TO MEDICAL TREATMENT WHEN PRESCRIBED BY PRIMARY CARE PHYSICIANS.	2013