1 1941 357 SAFETY AND EFFICACY OF AYURVEDIC INTERVENTIONS AND YOGA ON LONG TERM EFFECTS OF COVID-19: A STRUCTURED SUMMARY OF A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. OBJECTIVES: PRIMARY OBJECTIVE * TO ASSESS THE EFFICACY OF AYURVEDA INTERVENTIONS AND YOGA IN REHABILITATION OF COVID-19 CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 AS COMPARED TO WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19- RELATED ILLNESS. SECONDARY OBJECTIVE * TO ASSESS THE SAFETY OF AYURVEDIC INTERVENTIONS IN CASES SUFFERING WITH LONG TERM EFFECTS OF COVID 19 TRIAL DESIGN: MULTI-CENTRIC, RANDOMIZED, CONTROLLED, PARALLEL GROUP, OPEN-LABEL, EXPLORATORY STUDY. THE STUDY DURATION IS 9 MONTHS AND THE INTERVENTION PERIOD IS 90 DAYS FROM THE DAY OF ENROLMENT OF THE PARTICIPANT. PARTICIPANTS: PATIENTS OF EITHER SEX BETWEEN 18 TO 60 YEARS, AMBULATORY, WILLING TO PARTICIPATE, WITH HISTORY (NOT MORE THAN 4 WEEKS) OF POSITIVE RT-PCR FOR COVID-19 OR IGM ANTIBODIES POSITIVITY FOR SARS COV-2, BUT HAVING NEGATIVE RT-PCR FOR COVID-19 AT THE TIME OF SCREENING WILL BE CONSIDERED ELIGIBLE FOR ENROLMENT IN THE STUDY. CRITICALLY ILL PATIENTS WITH ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME), REQUIRING INVASIVE RESPIRATORY SUPPORT IN THE INTENSIVE CARE UNIT, KNOWN CASE OF ANY MALIGNANCY, IMMUNE-COMPROMISED STATE (E.G. HIV), DIABETES MELLITUS, ACTIVE PULMONARY TUBERCULOSIS, PAST HISTORY OF ANY CHRONIC RESPIRATORY DISEASE, MOTOR NEURON DISEASE, MULTIPLE SCLEROSIS, STROKE, IMPAIRED COGNITION, ATRIAL FIBRILLATION, ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, SEVERE ARRHYTHMIA, CONCURRENT SERIOUS HEPATIC DISEASE OR RENAL DISEASE, PREGNANT OR LACTATING WOMEN, PATIENTS ON IMMUNOSUPPRESSIVE MEDICATIONS, HISTORY OF HYPERSENSITIVITY TO THE TRIAL DRUGS OR THEIR INGREDIENTS, DEPRESSIVE ILLNESS (BEFORE COVID-19), DIAGNOSED PSYCHOTIC ILLNESSES, SUBSTANCE DEPENDENCE OR ALCOHOLISM WILL BE EXCLUDED. THE TRIAL WILL BE CONDUCTED AT TWO MEDICAL COLLEGES IN MAHARASHTRA, INDIA. INTERVENTION AND COMPARATOR: INTERVENTION ARM (GROUP-I): AYURVEDA INTERVENTIONS INCLUDING AGASTYA HARITAKI SIX GRAM AND ASHWAGANDHA TABLET 500 MG TWICE DAILY ORALLY AFTER MEALS WITH WARM WATER AND TWO SESSIONS OF YOGA (MORNING 30 MINUTES AND EVENING 15 MINUTES) DAILY FOR 90 DAYS, AS PER THE POST-COVID-19 CARE PROTOCOL PROVIDED IN NATIONAL CLINICAL MANAGEMENT PROTOCOL BASED ON AYURVEDA AND YOGA FOR MANAGEMENT OF COVID-19 PUBLISHED BY MINISTRY OF AYUSH, GOVERNMENT OF INDIA. COMPARATOR ARM (GROUP-II): WHO REHABILITATION SELF-MANAGEMENT AFTER COVID-19 RELATED ILLNESS FOR 90 DAYS. THE TRIAL DRUGS ARE BEING PROCURED FROM A GMP CERTIFIED PHARMACEUTICAL COMPANY. MAIN OUTCOMES: PRIMARY OUTCOME: CHANGE IN RESPIRATORY FUNCTION TO BE ASSESSED BY SAN DIEGO SHORTNESS OF BREATH QUESTIONNAIRE, 6-MINUTES WALK TEST AND PULMONARY FUNCTION TEST. SECONDARY OUTCOMES: CHANGE IN HIGH-RESOLUTION COMPUTED TOMOGRAPHY (HRCT) CHEST CHANGE IN FATIGUE SCORE ASSESSED BY MODIFIED FATIGUE IMPACT SCALE CHANGE IN ANXIETY SCORE ASSESSED BY HOSPITAL ANXIETY AND DEPRESSION SCALE SCORE CHANGE IN SLEEP QUALITY ASSESSED BY PITTSBURGH SLEEP QUALITY INDEX CHANGE IN THE QUALITY OF LIFE ASSESSED BY COV19-QOL SCALE SAFETY OF THE INTERVENTIONS WILL BE ASSESSED BY COMPARING HEMATOLOGICAL AND BIOCHEMICAL INVESTIGATIONS BEFORE AND AFTER THE INTERVENTION PERIOD AND ADVERSE EVENT/ ADVERSE DRUG REACTION TIMELINES FOR OUTCOME ASSESSMENT: SUBJECTIVE PARAMETERS AND CLINICAL ASSESSMENT WILL BE ASSESSED AT BASELINE, 15(TH) DAY, 30(TH) DAY, 60(TH) DAY AND 90(TH) DAY. LABORATORY PARAMETERS (CBC, LFT, KFT, HBA1C, HS-CRP, D-DIMER), PULMONARY FUNCTION TEST AND HRCT CHEST WILL BE DONE AT BASELINE AND AFTER COMPLETION OF STUDY PERIOD I.E. 90(TH) DAY. RANDOMISATION: STATISTICAL PACKAGE FOR SOCIAL SCIENCES (SPSS) VERSION 15.0 IS USED TO GENERATE THE RANDOM NUMBER SEQUENCES. THE PARTICIPANTS WILL BE RANDOMIZED TO TWO STUDY GROUPS IN THE RATIO OF 1:1. BLINDING (MASKING): THE STUDY IS OPEN-LABEL DESIGN. HOWEVER, THE OUTCOME ASSESSOR WILL BE KEPT BLINDED REGARDING THE STUDY GROUP ALLOCATION OF THE PARTICIPANTS. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: THE SAMPLE SIZE FOR THE STUDY IS CALCULATED ASSUMING IMPROVEMENT IN 6-MINUTES WALK TEST BY 40 METER IN GROUP I AND A CHANGE OF 10 METER IN GROUP II WITH A STANDARD DEVIATION OF 50 METER BASED ON THE RESULTS OF THE PREVIOUS STUDIES, WITH 95% CONFIDENCE LEVEL (ALPHA = 0.05) AND 80% POWER AND EXPECTING A DROPOUT RATE OF 20%. THE NUMBER OF PARTICIPANTS TO BE ENROLLED IN THE STUDY SHOULD BE APPROXIMATELY 55 IN EACH GROUP. HENCE, A TOTAL OF 110 PARTICIPANTS WILL BE ENROLLED IN THE TRIAL AT EACH STUDY SITE. TRIAL STATUS: PARTICIPANTS' RECRUITMENT STARTED ON 1(ST) MAY 2021. ANTICIPATED END OF RECRUITMENT IS AUGUST 2021. PROTOCOL NUMBER: CCRAS-01 PROTOCOL VERSION NUMBER: 1.1, 13TH JANUARY 2021. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE CLINICAL TRIAL REGISTRY OF INDIA (CTRI) ON 03(RD) MARCH 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: THE FULL PROTOCOL IS ATTACHED AS AN ADDITIONAL FILE, ACCESSIBLE FROM THE JOURNAL WEBSITE (ADDITIONAL FILE 1). THIS COMMUNICATION SERVES AS A SUMMARY OF THE KEY ELEMENTS OF THE FULL PROTOCOL. 2021 2 682 41 EFFECT OF ADJUNCT YOGA THERAPY IN DEPRESSIVE DISORDERS: FINDINGS FROM A RANDOMIZED CONTROLLED STUDY. BACKGROUND: DEPRESSION CAUSES SIGNIFICANT BURDEN BOTH TO THE INDIVIDUAL AND TO SOCIETY, AND ITS TREATMENT BY ANTIDEPRESSANTS HAS VARIOUS DISADVANTAGES. THERE IS PRELIMINARY EVIDENCE THAT ADDS ON YOGA THERAPY IMPROVES DEPRESSION BY IMPACTING THE NEUROTRANSMITTERS INVOLVED IN THE REGULATION OF MOOD, MOTIVATION, AND PLEASURE. OUR STUDY AIMED TO FIND THE EFFECT OF ADJUNCTIVE YOGA THERAPY ON OUTCOME OF DEPRESSION AND COMORBID ANXIETY. MATERIALS AND METHODS: A RANDOMIZED CONTROLLED STUDY INVOLVING PATIENTS WITH MAJOR DEPRESSIVE DISORDER (N = 80) WERE ALLOCATED TO TWO GROUPS, ONE RECEIVED STANDARD THERAPY (ANTIDEPRESSANTS AND COUNSELING) AND THE OTHER RECEIVED ADJUNCT YOGA THERAPY ALONG WITH STANDARD THERAPY. RATINGS OF DEPRESSION AND ANXIETY WERE DONE USING MONTGOMERY-ASBERG DEPRESSION RATING SCALE AND HOSPITAL ANXIETY AND DEPRESSION SCALE AT BASELINE, 10(TH) AND 30(TH) DAY. CLINICAL GLOBAL IMPRESSION (CGI) SCALE WAS APPLIED AT BASELINE AND 30(TH) DAY TO VIEW THE SEVERITY OF ILLNESS AND CLINICAL IMPROVEMENT. RESULTS: BY THE 30(TH) DAY, INDIVIDUALS IN THE YOGA GROUP HAD SIGNIFICANTLY LOWER SCORES OF DEPRESSION, ANXIETY, AND CGI SCORES, IN COMPARISON TO THE CONTROL GROUP. THE INDIVIDUALS IN THE YOGA GROUP HAD A SIGNIFICANT FALL IN DEPRESSION SCORES AND SIGNIFICANT CLINICAL IMPROVEMENT, COMPARED TO THE CONTROL GROUP, FROM BASELINE TO 30(TH) DAY AND 10(TH) TO 30(TH) DAY. IN ADDITION, THE INDIVIDUALS IN THE YOGA GROUP HAD A SIGNIFICANT FALL IN ANXIETY SCORES FROM BASELINE TO 10(TH) DAY. CONCLUSION: ANXIETY STARTS TO IMPROVE WITH SHORT-TERM YOGA SESSIONS, WHILE LONG-TERM YOGA THERAPY IS LIKELY TO BE BENEFICIAL IN THE TREATMENT OF DEPRESSION. 2019 3 1370 55 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 4 2187 58 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 5 2394 62 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 6 1242 55 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 7 2036 62 TELE-YOGA IN LONG TERM ILLNESS-PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL INCLUDING A PROCESS EVALUATION AND RESULTS FROM A PILOT STUDY. BACKGROUND: FOR PEOPLE WITH LONG-TERM ILLNESS, DEBILITATED BY SEVERE SYMPTOMS, IT CAN BE DIFFICULT TO ATTEND REGULAR YOGA CLASSES. WE HAVE THEREFORE DEVELOPED A TELE-HEALTH FORMAT OF YOGA THAT CAN BE DELIVERED IN THE HOME. THE TELE-YOGA WAS CO-DESIGNED WITH MEMBERS OF A PATIENT-ORGANISATION, YOGA-INSTRUCTOR, AND IT-TECHNICIAN. IT INCLUDES LIVE-STREAMED GROUP-YOGA SESSIONS TWICE A WEEK AND AN APP WITH INSTRUCTIONS ON HOW TO SELF-PERFORM YOGA. AIM: TO DESCRIBE A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (RCT) INCLUDING A PROCESS EVALUATION AND REPORT ON A PILOT STUDY EVALUATING METHOD- AND INTERVENTION-RELATED COMPONENTS INCLUDING FEASIBILITY, SAFETY, AND EFFICACY. METHODS: TEN PARTICIPANTS WITH HEART FAILURE AGED BETWEEN 41-76 YEARS WERE RANDOMISED TO TELE-YOGA (N = 5) OR TO THE CONTROL GROUP (N = 5). IN THE PILOT STUDY RECRUITMENT, ENROLMENT, RANDOMISATION, AND DATA COLLECTION OF ALL OUTCOMES INCLUDING PRIMARY, SECONDARY AND PROCESS EVALUATION MEASURES WERE TESTED ACCORDING TO THE STUDY PROTOCOL. FIDELITY, ADHERENCE AND ACCEPTABILITY TO THE TELE-YOGA GROUP TRAINING AND APP USE WAS DETERMINED. SAFETY WAS ASSESSED BY ADVERSE EVENTS. RESULTS: THE PILOT REVEALED THAT THE METHODOLOGICAL ASPECT OF THE PROTOCOL WORKED SUFFICIENTLY IN ALL ASPECTS EXCEPT FOR MISSING DATA IN THE PHYSICAL TEST OF TWO PARTICIPANTS AND ONE PARTICIPANT IN THE CONTROL-GROUP THAT DROPPED OUT OF THE STUDY AT THREE MONTHS FOLLOW-UP. THE TELE-YOGA TRAINING DID NOT LEAD TO ANY ADVERSE EVENTS OR INJURIES, ADHERENCE OF TELE-YOGA WAS SUFFICIENT ACCORDING TO PRESET LIMITS. THE TELE-YOGA INTERVENTION ALSO SHOWED SOME FAVOURABLE TRENDS OF IMPROVEMENTS IN THE COMPOSITE-END POINT COMPARED TO THE ACTIVE CONTROL GROUP. HOWEVER, SINCE DATA ONLY WAS PRESENTED DESCRIPTIVELY DUE TO THE SMALL SAMPLE SIZE, THE IMPACT OF THESE TRENDS SHOULD BE INTERPRETED CAREFULLY. CONCLUSION: OUR PILOT STUDY SHOWED PROMISING RESULTS IN FEASIBILITY, SAFETY, AND ACCEPTABILITY OF THE TELE-YOGA INTERVENTION. SOME CHANGES IN THE PROTOCOL HAVE BEEN MADE TO DECREASE THE RISK OF MISSING DATA IN THE MEASURES OF PHYSICAL FUNCTION AND IN THE FULL-SCALE RCT NOW ONGOING THE RESULTS OF THE SAMPLE SIZE CALCULATION FOR 300 PARTICIPANTS HAVE INCLUDED THE ESTIMATED LEVEL OF DROP OUTS AND MISSING DATA. 2021 8 301 62 AN ASSESSMENT OF THE EFFECTS OF IYENGAR YOGA PRACTICE ON THE HEALTH-RELATED QUALITY OF LIFE OF PATIENTS WITH CHRONIC RESPIRATORY DISEASES: A PILOT STUDY. OBJECTIVE: TO ASSESS THE EFFECTS OF AN IYENGAR YOGA PROGRAM (IYP) ON PATIENTS WITH CHRONIC RESPIRATORY DISEASES. METHODS: PATIENTS ATTENDING LUNG TRANSPLANT CLINICS IN A TERTIARY INSTITUTION WERE INVITED TO PARTICIPATE IN A TWO-PHASE, 12-WEEK IYP THAT INCLUDED 2 H BIWEEKLY CLASSES. DOCTORS COMPLETED A FORMAL PHYSICAL AND CLINICAL ASSESSMENT ON CANDIDATES BEFORE ENROLLMENT. PATIENTS WITH NEW YORK ASSOCIATION CLASS III OR IV, OR DYSPNEA GRADE IV WERE EXCLUDED. AT BASELINE AND AT THE END OF 12-WEEKS, PATIENTS COMPLETED THE HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS), CHRONIC RESPIRATORY QUESTIONNAIRE (CRQ) AND HEALTH UTILITIES INDEX (HUI). MEDICATION(S), 6 MIN WALK TEST RESULTS AND OTHER CLINICAL PARAMETERS WERE ALSO RECORDED. PATIENTS RECORDED THE EFFECTS OF THE IYP ON THEIR DAILY LIVING IN JOURNALS. NONPARAMETRIC AND QUALITATIVE METHODS WERE USED TO ANALYZE THE DATA. RESULTS: TWENTY-FIVE PATIENTS DIAGNOSED WITH PULMONARY ARTERIAL HYPERTENSION AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MEAN AGE 60 YEARS) WERE INVITED TO PARTICIPATE. AT THE END OF THE 12-WEEK PERIOD, CHANGES IN HADS ANXIETY AND CRQ FATIGUE SCORES WERE STATISTICALLY SIGNIFICANT (P<0.05) AND CHANGES IN HUI AMBULATION, PAIN, EMOTION AND OVERALL SCORE WERE CLINICALLY IMPORTANT. THE CONTENT OF THE JOURNALS REVEALED PATIENTS' IMPROVEMENT IN BREATHING CAPACITY, MOBILITY, ENERGY, SLEEP AND INCLUDED POSITIVE FEEDBACK SUCH AS: "INCREASED TIDAL VOLUME WITH SLOWING EXPIRATION", "I HAVE AN OVERALL FEELING OF WELLBEING" AND "EXCELLENT AMOUNT OF ENERGY". CONCLUSIONS: THE FINDINGS SUGGEST THAT YOGA HAS SIGNIFICANT POTENTIAL TO PRODUCE BENEFITS. POTENTIAL BENEFITS WILL BE FURTHER EXPLORED IN A NATIONAL MULTISITE STUDY. 2013 9 1402 63 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/ 0.05). STATISTICALLY SIGNIFICANT DIFFERENCE WAS OBSERVED IN THE MEAN LEVEL OF PERCEIVED FATIGUE IN TRIPLICATE MEASUREMENTS (P = 0.013) AMONG PATIENTS WHO COMPLETED INDIVIDUAL EXERCISE. HOWEVER, THIS DIFFERENCE WAS NOT SIGNIFICANT IN THE GROUP EXERCISE. CONCLUSION: PERFORMING MILD STRETCHING EXERCISES AND BASIC YOGA ARE RECOMMENDED AS A COST-EFFECTIVE METHOD WHICH IS EASY TO PERFORM AMONG PATIENTS WITH MILD TO MODERATE DISABILITIES. 2015 19 1939 55 ROLE OF YOGA THERAPY IN IMPROVING DIGESTIVE HEALTH AND QUALITY OF SLEEP IN AN ELDERLY POPULATION: A RANDOMIZED CONTROLLED TRIAL. INTRODUCTION: CONSTIPATION AND SLEEP DISTURBANCES COMMONLY AFFECT ELDERLY POPULATION RESULTS IN COMPROMISED PHYSICAL AND MENTAL HEALTH. MIND-BODY INTERVENTIONS LIKE YOGA NOT ONLY ADDRESS THE MENTAL AND PHYSICAL HEALTH BUT ALSO PROMOTE HEALTHY AGEING. THIS STUDY EVALUATES THE EFFECT OF 3 MONTHS YOGA INTERVENTION ON THE SLEEP AND CONSTIPATION RELATED QUALITY OF LIFE (QOL) AMONG THE ELDERLY. MATERIALS AND METHODS: NINETY SIX PARTICIPANTS AGED BETWEEN 60 AND 75 WHO DID NOT HAD ANY HISTORY OF YOGA PRACTICE FOR PAST 1 YEAR AND HAVING A ZUBROD SCORE OF 0-2 WERE RANDOMIZED IN TO YOGA (N = 48) OR WAITLISTED CONTROL (N = 48). THE YOGA GROUP RECEIVED YOGA INTERVENTIONS AT A FREQUENCY OF 3 SESSIONS PER WEEK FOR 3 MONTHS. PITTSBURG SLEEP QUALITY INDEX (PSQI) AND PATIENT ASSESSMENT OF CONSTIPATION QOL (PAC-QOL) WERE USED TO ASSESS THE IMPROVEMENT. INTENTION TO TREAT ANALYSIS METHOD WAS USED TO INCLUDE THE DROP-OUT PARTICIPANTS. RESULTS: EIGHTY ONE PARTICIPANTS (YOGA = 48, WAITLISTED CONTROL = 33) COMPLETED THE STUDY. WILCOXON'S SIGN RANK TEST HAS SHOWN THAT THE YOGA GROUP HAD STATISTICALLY SIGNIFICANT CHANGES IN MOST OF THE PARAMETERS IN PSQI AND PAC-QOL (P