1 70 136 A FEASIBILITY STUDY EXAMINING THE IMPACT OF YOGA ON PSYCHOSOCIAL HEALTH AND SYMPTOMS IN PEDIATRIC OUTPATIENTS RECEIVING CHEMOTHERAPY. PURPOSE: PEDIATRIC CANCER PATIENTS EXPERIENCE SYMPTOMS THAT NEGATIVELY IMPACT QUALITY OF LIFE; YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF A 10-WEEK, WEEKLY INDIVIDUALIZED YOGA INTERVENTION FOR CHILDREN AND ADOLESCENTS RECEIVING OUTPATIENT CANCER THERAPY PRIMARILY DELIVERED REMOTELY USING SKYPE. SECONDARY OBJECTIVES WERE TO DESCRIBE DEPRESSION, ANXIETY, ANGER, FATIGUE, QUALITY OF LIFE, AND SYMPTOMS AT 5 AND 10 WEEKS AFTER ENROLLMENT. METHODS: WE INCLUDED ENGLISH-SPEAKING PATIENTS AGED 10 TO 18 YEARS RECEIVING OUTPATIENT CHEMOTHERAPY FOR CANCER. WEEKLY INDIVIDUALIZED YOGA SESSIONS WERE OFFERED FOR 10 WEEKS. WEEKS 1, 5, AND 10 WERE IN-HOSPITAL WHILE THE REMAINING SESSIONS WERE DELIVERED REMOTELY USING SKYPE. TWICE WEEKLY, HOMEWORK WAS ASSIGNED BETWEEN EACH SESSION. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS 80% OF PARTICIPANTS COMPLETING AT LEAST 60% OF PLANNED IN-HOSPITAL OR REMOTE YOGA SESSIONS. RESULTS: BETWEEN MARCH AND NOVEMBER 2017, 10 PATIENTS WERE ENROLLED. TWO PATIENTS DISCONTINUED THE STUDY AFTER ONE AND TWO SESSIONS. ONLY SIX PARTICIPANTS ACHIEVED AT LEAST 60% OF PLANNED YOGA SESSIONS AND THUS, THE STUDY DID NOT MEET THE A PRIORI DEFINED FEASIBILITY THRESHOLD. AMONG ALL PARTICIPANTS, ONLY ONE HOMEWORK SESSION WAS PERFORMED. CONCLUSIONS: A 10-WEEK INDIVIDUALIZED IN-PERSON AND REMOTELY CONDUCTED YOGA INTERVENTION WAS NOT FEASIBLE IN CHILDREN RECEIVING CANCER TREATMENTS BECAUSE OF FAILURE TO ACHIEVE THE DESIRED FREQUENCY OF YOGA SESSIONS IN A SUFFICIENT NUMBER OF PARTICIPANTS. FUTURE RESEARCH SHOULD IDENTIFY APPROACHES TO IMPROVE COMPLIANCE WITH REMOTE YOGA SESSIONS AND HOME PRACTICE. TRIAL REGISTRATION: NCT03318068. 2019 2 71 37 A FEASIBILITY STUDY OF RESTORATIVE YOGA VERSUS VIGOROUS YOGA INTERVENTION FOR SEDENTARY BREAST AND OVARIAN CANCER SURVIVORS. YOGA HAS BEEN SHOWN TO IMPROVE CANCER SURVIVORS' QUALITY OF LIFE, YET REGULAR YOGA PRACTICE IS A CHALLENGE FOR THOSE WHO ARE SEDENTARY. WE CONDUCTED A PILOT RANDOMIZED CONTROLLED STUDY TO ASSESS FEASIBILITY AND ADHERENCE OF TWO TYPES OF YOGA INTERVENTION AMONG SEDENTARY CANCER SURVIVORS. SEDENTARY BREAST AND OVARIAN CANCER SURVIVORS WERE RANDOMIZED TO PRACTICE EITHER RESTORATIVE YOGA (MINIMAL PHYSICAL EXERTION, GROUP R) OR VIGOROUS YOGA (CONSIDERABLE PHYSICAL EXERTION, GROUP V) IN THREE 60-MINUTE SUPERVISED SESSIONS A WEEK FOR 12 WEEKS, FOLLOWED BY 12 WEEKS OF HOME PRACTICE. ACCRUAL, ADHERENCE, AND ATTENDANCE RATES WERE ASSESSED. OF THE 226 ELIGIBLE PATIENTS, 175 (77%) DECLINED TO PARTICIPATE IN THE STUDY, CITING TIME COMMITMENT AND TRAVEL AS THE MOST COMMON BARRIERS. FORTY-TWO SUBJECTS CONSENTED TO PARTICIPATE IN THE STUDY. OF THE 35 PARTICIPANTS WHO BEGAN THE INTERVENTION (20 IN GROUP R AND 15 IN GROUP V), ADHERENCE RATE (PERCENTAGE REMAINING IN THE STUDY AT WEEK 12) WAS 100% AND 87%, RESPECTIVELY. RATE OF ADEQUATE ATTENDANCE (MORE THAN 66% OF THE SCHEDULED SUPERVISED SESSIONS) WAS 85% AND 73%, RESPECTIVELY. RATE OF COMPLETION OF THE HOME PRACTICE PERIOD WAS 85% AND 77%, RESPECTIVELY. IN THIS STUDY, SEDENTARY CANCER SURVIVORS WERE ABLE TO ADHERE TO A LONG-TERM, REGULAR YOGA REGIMEN. THE RATE OF ADEQUATE ATTENDANCE WAS HIGHER FOR RESTORATIVE YOGA. FUTURE STUDIES FOR SEDENTARY PATIENTS SHOULD FOCUS ON REDUCING TIME COMMITMENT AND TRAVEL REQUIREMENTS TO IMPROVE RECRUITMENT, AND ON USING RESTORATIVE YOGA AS A MORE FEASIBLE INTERVENTION FOR THIS POPULATION. 2018 3 312 39 AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL OF A 12-WEEK YOGA VERSUS EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME: FEASIBILITY AND ACCEPTABILITY. OBJECTIVES: THE PRIMARY OBJECTIVES OF THIS PILOT TRIAL WERE TO ASSESS THE STUDY FEASIBILITY AND ACCEPTABILITY OF THE 12-WEEK YOGA AND EDUCATIONAL FILM PROGRAMS FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS) IN PREPARATION FOR A FUTURE RANDOMIZED CONTROLLED TRIAL (RCT). MATERIALS AND METHODS: THIS PILOT, PARALLEL-ARM, RANDOMIZED FEASIBILITY TRIAL WAS CONDUCTED AT TWO SITES, MORGANTOWN, WV AND COLUMBUS, OH. YOGA GROUP PARTICIPANTS ATTENDED 75-MIN IYENGAR YOGA CLASSES, TWICE WEEKLY FOR 4 WEEKS, THEN ONCE A WEEK FOR 8 WEEKS (16 TOTAL CLASSES), AND COMPLETED A 30-MIN HOMEWORK ROUTINE ON NONCLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS ATTENDED ONCE WEEKLY, 75-MIN CLASSES (12 TOTAL CLASSES), WHICH INCLUDED INFORMATION ON RLS AND OTHER SLEEP DISORDERS, RLS MANAGEMENT INCLUDING SLEEP HYGIENE PRACTICES, AND COMPLEMENTARY THERAPIES. FEASIBILITY AND ACCEPTABILITY OUTCOMES INCLUDED PROGRAM SATISFACTION AND RECRUITMENT, RETENTION, AND ADHERENCE RATES. IN ADDITION, PARTICIPANTS WERE ASKED THEIR PREFERENCES REGARDING THREE YOGA CLASS SCHEDULE SCENARIOS FOR A FUTURE STUDY. ATTENDANCE, YOGA, AND TREATMENT LOGS WERE COLLECTED WEEKLY. PROGRAM EVALUATION AND YOGA SCHEDULING QUESTIONNAIRES WERE COLLECTED AT WEEK 12. RESULTS: FORTY-ONE ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EDUCATIONAL FILM (N = 22) PROGRAM. THIRTY PARTICIPANTS (73%) COMPLETED THE PROGRAM. YOGA AND EDUCATION GROUP PARTICIPANTS ATTENDED AN AVERAGE OF 13.0 +/- 0.84 (81%) AND 10.3 +/- 0.3 CLASSES (85%), RESPECTIVELY. PARTICIPANTS FROM BOTH GROUPS INDICATED SATISFACTION WITH THE STUDY. ALL YOGA GROUP RESPONDENTS TO THE PROGRAM EVALUATION REPORTED THEY WOULD LIKELY (N = 6) OR VERY LIKELY (N = 7) CONTINUE YOGA PRACTICE; 86.7% OF EDUCATION GROUP RESPONDENTS (13 OF 15) INDICATED THAT THEY WERE LIKELY (N = 7) OR VERY LIKELY (N = 6) TO MAKE LASTING CHANGES BASED ON WHAT THEY HAD LEARNED. THE PREFERRED SCHEDULE FOR A FUTURE STUDY WAS A 16-WEEK STUDY WITH ONCE-WEEKLY YOGA CLASSES. CONCLUSIONS: THE FINDINGS OF THIS STUDY SUGGEST THAT A LARGER RCT COMPARING YOGA WITH AN EDUCATIONAL FILM GROUP FOR THE MANAGEMENT OF RLS IS FEASIBLE. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT03570515; 02/01/2017. 2022 4 162 42 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 5 1240 42 FEASIBILITY OF A MINDFUL YOGA PROGRAM FOR WOMEN WITH METASTATIC BREAST CANCER: RESULTS OF A RANDOMIZED PILOT STUDY. PURPOSE: PATIENTS WITH METASTATIC BREAST CANCER (MBC) EXPERIENCE HIGH LEVELS OF SYMPTOMS. YOGA INTERVENTIONS HAVE SHOWN PROMISE FOR IMPROVING CANCER SYMPTOMS BUT HAVE RARELY BEEN TESTED IN PATIENTS WITH ADVANCED DISEASE. THIS STUDY EXAMINED THE ACCEPTABILITY OF A COMPREHENSIVE YOGA PROGRAM FOR MBC AND THE FEASIBILITY OF CONDUCTING A RANDOMIZED TRIAL TESTING THE INTERVENTION. METHODS: SIXTY-THREE WOMEN WITH MBC WERE RANDOMIZED WITH A 2:1 ALLOCATION TO YOGA OR A SUPPORT GROUP COMPARISON CONDITION. BOTH INTERVENTIONS INVOLVED EIGHT WEEKLY GROUP SESSIONS. FEASIBILITY WAS QUANTIFIED USING RATES OF ACCRUAL, ATTRITION, AND SESSION ATTENDANCE. ACCEPTABILITY WAS ASSESSED WITH A STANDARDIZED SELF-REPORT MEASURE. PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS, AND FUNCTIONAL CAPACITY WERE ASSESSED AT BASELINE, POST-INTERVENTION, AND 3 AND 6 MONTHS POST-INTERVENTION. RESULTS: WE MET GOALS FOR ACCRUAL AND RETENTION, WITH 50% OF ELIGIBLE PATIENTS ENROLLED AND 87% OF RANDOMIZED PARTICIPANTS COMPLETING POST-INTERVENTION SURVEYS. SIXTY-FIVE PERCENT OF WOMEN IN THE YOGA CONDITION AND 90% IN THE SUPPORT GROUP ATTENDED >/= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION. 2019 6 2628 35 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS. 2018 7 1140 44 EFFICACY OF YOGA VS COGNITIVE BEHAVIORAL THERAPY VS STRESS EDUCATION FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER: A RANDOMIZED CLINICAL TRIAL. IMPORTANCE: GENERALIZED ANXIETY DISORDER (GAD) IS COMMON, IMPAIRING, AND UNDERTREATED. ALTHOUGH MANY PATIENTS WITH GAD SEEK COMPLEMENTARY AND ALTERNATIVE INTERVENTIONS, INCLUDING YOGA, DATA SUPPORTING YOGA'S EFFICACY OR HOW IT COMPARES TO FIRST-LINE TREATMENTS ARE LACKING. OBJECTIVES: TO ASSESS WHETHER YOGA (KUNDALINI YOGA) AND COGNITIVE BEHAVIORAL THERAPY (CBT) FOR GAD ARE EACH MORE EFFECTIVE THAN A CONTROL CONDITION (STRESS EDUCATION) AND WHETHER YOGA IS NONINFERIOR TO CBT FOR THE TREATMENT OF GAD. DESIGN, SETTING, AND PARTICIPANTS: FOR THIS RANDOMIZED, 3-ARM, CONTROLLED, SINGLE-BLIND (MASKED INDEPENDENT RATERS) CLINICAL TRIAL, PARTICIPANTS WERE RECRUITED FROM 2 SPECIALTY ACADEMIC CENTERS STARTING DECEMBER 1, 2013, WITH ASSESSMENT ENDING OCTOBER 25, 2019. PRIMARY ANALYSES, COMPLETED BY FEBRUARY 12, 2020, INCLUDED SUPERIORITY TESTING OF KUNDALINI YOGA AND CBT VS STRESS EDUCATION AND NONINFERIORITY TESTING OF KUNDALINI YOGA VS CBT. INTERVENTIONS: PARTICIPANTS WERE RANDOMIZED TO KUNDALINI YOGA (N = 93), CBT FOR GAD (N = 90), OR STRESS EDUCATION (N = 43), WHICH WERE EACH DELIVERED TO GROUPS OF 4 TO 6 PARTICIPANTS BY 2 INSTRUCTORS DURING TWELVE 120-MINUTE SESSIONS WITH 20 MINUTES OF DAILY HOMEWORK. MAIN OUTCOMES AND MEASURES: THE PRIMARY INTENTION-TO-TREAT OUTCOME WAS ACUTE GAD RESPONSE (CLINICAL GLOBAL IMPRESSION-IMPROVEMENT SCALE SCORE OF MUCH OR VERY MUCH IMPROVED) AFTER 12 WEEKS AS ASSESSED BY TRAINED INDEPENDENT RATERS. RESULTS: OF 538 PARTICIPANTS WHO PROVIDED CONSENT AND WERE EVALUATED, 226 (MEAN [SD] AGE, 33.4 [13.5] YEARS; 158 [69.9%] FEMALE) WITH A PRIMARY DIAGNOSIS OF GAD WERE INCLUDED IN THE TRIAL. A TOTAL OF 155 PARTICIPANTS (68.6%) COMPLETED THE POSTTREATMENT ASSESSMENT. COMPLETION RATES DID NOT DIFFER (KUNDALINI YOGA, 60 [64.5%]; CBT, 67 [74.4%]; AND STRESS EDUCATION, 28 [65.1%]: CHI2 = 2.39, DF = 2, P = .30). RESPONSE RATES WERE HIGHER IN THE KUNDALINI YOGA GROUP (54.2%) THAN IN THE STRESS EDUCATION GROUP (33.%) (ODDS RATIO [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; NUMBER NEEDED TO TREAT, 4.59 [95% CI, 2.52-46.19]) AND IN THE CBT GROUP (70.8%) COMPARED WITH THE STRESS EDUCATION GROUP (33.0%) (OR, 5.00 [95% CI, 2.12-11.82]; P < .001; NUMBER NEEDED TO TREAT, 2.62 [95% CI, 1.91-5.68]). HOWEVER, THE NONINFERIORITY TEST DID NOT FIND KUNDALINI YOGA TO BE AS EFFECTIVE AS CBT (DIFFERENCE, 16.6%; P = .42 FOR NONINFERIORITY). CONCLUSIONS AND RELEVANCE: IN THIS TRIAL, KUNDALINI YOGA WAS EFFICACIOUS FOR GAD, BUT THE RESULTS SUPPORT CBT REMAINING FIRST-LINE TREATMENT. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT01912287. 2021 8 2811 38 YOGA TO PREVENT MOBILITY LIMITATIONS IN OLDER ADULTS: FEASIBILITY OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: THE LOSS OF MOBILITY DURING AGING IMPACTS INDEPENDENCE AND LEADS TO FURTHER DISABILITY, MORBIDITY, AND REDUCED LIFE EXPECTANCY. OUR OBJECTIVE WAS TO EXAMINE THE FEASIBILITY AND SAFETY OF CONDUCTING A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR OLDER ADULTS AT RISK FOR MOBILITY LIMITATIONS. METHODS: SEDENTARY OLDER ADULTS (N = 46; AGE 60-89) WERE RECRUITED AND RANDOMIZED TO EITHER YOGA OR A HEALTH EDUCATION COMPARISON GROUP. YOGA SESSIONS (60-MIN) OCCURRED 2X WEEKLY, AND 90-MIN HEALTH EDUCATION SESSIONS OCCURRED WEEKLY, FOR 10 WEEKS. THE PRIMARY OUTCOMES WERE RECRUITMENT RATE, INTERVENTION ATTENDANCE, AND RETENTION AT ASSESSMENTS. ADVERSE EVENT RATES AND PARTICIPANT SATISFACTION WERE ALSO MEASURED. PHYSICAL PERFORMANCE MEASURES OF GAIT, BALANCE, AND STRENGTH AND SELF-REPORT OUTCOME MEASURES WERE ADMINISTERED AT BASELINE AND 10-WEEKS. RESULTS: RECRUITMENT LASTED 6 MONTHS. RETENTION OF PARTICIPANTS AT THE 10-WEEK FOLLOW-UP WAS HIGH (89% - PERFORMANCE MEASURES; 98% - SELF-REPORT QUESTIONNAIRES). ATTENDANCE WAS GOOD WITH 82% OF YOGA AND 74% OF HEALTH EDUCATION PARTICIPANTS ATTENDING AT LEAST 50% OF THE SESSIONS. NO SERIOUS ADVERSE EVENTS WERE REPORTED. PATIENT SATISFACTION WITH THE INTERVENTIONS WAS HIGH. THE MEAN EFFECT SIZE FOR THE PHYSICAL PERFORMANCE MEASURES WAS 0.35 WITH SOME OVER 0.50. THE MEAN EFFECT SIZE FOR SELF-REPORT OUTCOME MEASURES WAS 0.36. CONCLUSIONS: RESULTS INDICATE THAT IT IS FEASIBLE TO CONDUCT A LARGER RCT OF YOGA FOR SEDENTARY OLDER ADULTS AT RISK FOR MOBILITY PROBLEMS. THE YOGA AND COMPARISON INTERVENTIONS WERE SAFE, WELL ACCEPTED, AND WELL ATTENDED. EFFECT SIZES SUGGEST YOGA MAY HAVE IMPORTANT BENEFITS FOR THIS POPULATION AND SHOULD BE STUDIED FURTHER. TRIAL REGISTRATION: CLINICALTRIALS # NCT03544879 ; RETROSPECTIVELY REGISTERED 4 JUNE, 2018. 2018 9 2036 51 TELE-YOGA IN LONG TERM ILLNESS-PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL INCLUDING A PROCESS EVALUATION AND RESULTS FROM A PILOT STUDY. BACKGROUND: FOR PEOPLE WITH LONG-TERM ILLNESS, DEBILITATED BY SEVERE SYMPTOMS, IT CAN BE DIFFICULT TO ATTEND REGULAR YOGA CLASSES. WE HAVE THEREFORE DEVELOPED A TELE-HEALTH FORMAT OF YOGA THAT CAN BE DELIVERED IN THE HOME. THE TELE-YOGA WAS CO-DESIGNED WITH MEMBERS OF A PATIENT-ORGANISATION, YOGA-INSTRUCTOR, AND IT-TECHNICIAN. IT INCLUDES LIVE-STREAMED GROUP-YOGA SESSIONS TWICE A WEEK AND AN APP WITH INSTRUCTIONS ON HOW TO SELF-PERFORM YOGA. AIM: TO DESCRIBE A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (RCT) INCLUDING A PROCESS EVALUATION AND REPORT ON A PILOT STUDY EVALUATING METHOD- AND INTERVENTION-RELATED COMPONENTS INCLUDING FEASIBILITY, SAFETY, AND EFFICACY. METHODS: TEN PARTICIPANTS WITH HEART FAILURE AGED BETWEEN 41-76 YEARS WERE RANDOMISED TO TELE-YOGA (N = 5) OR TO THE CONTROL GROUP (N = 5). IN THE PILOT STUDY RECRUITMENT, ENROLMENT, RANDOMISATION, AND DATA COLLECTION OF ALL OUTCOMES INCLUDING PRIMARY, SECONDARY AND PROCESS EVALUATION MEASURES WERE TESTED ACCORDING TO THE STUDY PROTOCOL. FIDELITY, ADHERENCE AND ACCEPTABILITY TO THE TELE-YOGA GROUP TRAINING AND APP USE WAS DETERMINED. SAFETY WAS ASSESSED BY ADVERSE EVENTS. RESULTS: THE PILOT REVEALED THAT THE METHODOLOGICAL ASPECT OF THE PROTOCOL WORKED SUFFICIENTLY IN ALL ASPECTS EXCEPT FOR MISSING DATA IN THE PHYSICAL TEST OF TWO PARTICIPANTS AND ONE PARTICIPANT IN THE CONTROL-GROUP THAT DROPPED OUT OF THE STUDY AT THREE MONTHS FOLLOW-UP. THE TELE-YOGA TRAINING DID NOT LEAD TO ANY ADVERSE EVENTS OR INJURIES, ADHERENCE OF TELE-YOGA WAS SUFFICIENT ACCORDING TO PRESET LIMITS. THE TELE-YOGA INTERVENTION ALSO SHOWED SOME FAVOURABLE TRENDS OF IMPROVEMENTS IN THE COMPOSITE-END POINT COMPARED TO THE ACTIVE CONTROL GROUP. HOWEVER, SINCE DATA ONLY WAS PRESENTED DESCRIPTIVELY DUE TO THE SMALL SAMPLE SIZE, THE IMPACT OF THESE TRENDS SHOULD BE INTERPRETED CAREFULLY. CONCLUSION: OUR PILOT STUDY SHOWED PROMISING RESULTS IN FEASIBILITY, SAFETY, AND ACCEPTABILITY OF THE TELE-YOGA INTERVENTION. SOME CHANGES IN THE PROTOCOL HAVE BEEN MADE TO DECREASE THE RISK OF MISSING DATA IN THE MEASURES OF PHYSICAL FUNCTION AND IN THE FULL-SCALE RCT NOW ONGOING THE RESULTS OF THE SAMPLE SIZE CALCULATION FOR 300 PARTICIPANTS HAVE INCLUDED THE ESTIMATED LEVEL OF DROP OUTS AND MISSING DATA. 2021 10 599 40 DEVELOPMENT AND TESTING OF AN AUDIO-VISUAL SELF-HELP YOGA MANUAL FOR INDIAN CAREGIVERS OF PERSONS WITH SCHIZOPHRENIA LIVING IN THE COMMUNITY: A SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL. BACKGROUND: TO TEST THE FEASIBILITY AND EFFECTIVENESS OF AN AUDIO-VISUAL SELF-HELP AUDIO-VISUAL YOGA MANUAL ON BURDEN OF INDIAN CAREGIVERS OF PERSONS WITH SCHIZOPHRENIA, LIVING IN THE COMMUNITY. METHODS: AN EARLIER DEVELOPED YOGA PROGRAM FOR CAREGIVERS OF SCHIZOPHRENIA WAS REMODELED INTO AN AUDIO-VISUAL SELF-HELP MANUAL IN THREE LANGUAGES AND VALIDATED BY MENTAL HEALTH AND YOGA EXPERTS. 48 CONSENTING PRIMARY FAMILY CAREGIVERS OF OUTPATIENTS WITH SCHIZOPHRENIA WERE SCREENED, RECRUITED, AND ALLOTTED RANDOMLY TO YOGA OR CARE AS USUAL GROUP. PARTICIPANTS IN YOGA GROUP WERE TAUGHT YOGA FROM THE SELF-HELP MANUAL (1 SESSION OF 1 H EVERY MONTH FOR 5 MONTHS). THE CAREGIVERS WERE ASKED TO FOLLOW THE MANUAL FOR THE REMAINING MONTH AT HOME. ASSESSMENTS OF BURDEN, PERCEIVED STRESS, QUALITY OF LIFE, AND ANXIETY-DEPRESSION WERE CONDUCTED BY A RATER BLIND TO THE GROUP STATUS AT BASELINE AND AT THE END OF EVERY MONTH. RESULTS: POST FACTORING FOR MISSING DATA, REPEATEDMEASURE ANOVA WAS CONDUCTED; WHICH SHOWED THAT THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUP THAT PRACTICED THE SELFHELP YOGA MANUAL AND THE CARE AS USUAL GROUP. THE CAREGIVERS WHO PRACTICED YOGA AT HOME MAINTAINED AN AVERAGE OF 50% ATTENDANCE AND "VERY WELL" LEVEL OF YOGA PERFORMANCE. CONCLUSION: THE AUDIO-VISUAL SELF-HELP YOGA MANUAL WAS FOUND TO BE FEASIBLE TO USE BY THE CAREGIVERS EVEN THOUGH ITS EFFECTIVENESS COULD NOT BE ASCERTAINED DUE TO HIGH ATTRITION. 2020 11 258 43 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 12 106 23 A PILOT RANDOMIZED CONTROLLED TRIAL COMPARING PRENATAL YOGA TO PERINATAL HEALTH EDUCATION FOR ANTENATAL DEPRESSION. WE CONDUCTED A PILOT RANDOMIZED CONTROLLED TRIAL (RCT) COMPARING A PRENATAL YOGA INTERVENTION TO PERINATAL-FOCUSED HEALTH EDUCATION IN PREGNANT WOMEN WITH DEPRESSION. FINDINGS DOCUMENT ACCEPTABILITY AND FEASIBILITY OF THE YOGA INTERVENTION: NO YOGA-RELATED INJURIES WERE OBSERVED, INSTRUCTORS SHOWED FIDELITY TO THE YOGA MANUAL, AND WOMEN RATED INTERVENTIONS AS ACCEPTABLE. ALTHOUGH IMPROVEMENTS IN DEPRESSION WERE NOT STATISTICALLY DIFFERENT BETWEEN GROUPS, THEY FAVORED YOGA. THIS STUDY PROVIDES SUPPORT FOR A LARGER SCALE RCT EXAMINING PRENATAL YOGA TO IMPROVE MOOD DURING PREGNANCY. 2016 13 2701 48 YOGA INTERVENTION FOR PATIENTS WITH PROSTATE CANCER UNDERGOING EXTERNAL BEAM RADIATION THERAPY: A PILOT FEASIBILITY STUDY. PURPOSE: STUDIES HAVE DEMONSTRATED BENEFICIAL HEALTH EFFECTS FROM YOGA INTERVENTIONS IN CANCER PATIENTS, BUT PREDOMINANTLY IN BREAST CANCER. RESEARCH ON ITS ROLE IN ALLEVIATING PROSTATE CANCER (PC) PATIENTS' SIDE EFFECTS HAS BEEN LACKING. OUR PRIMARY GOAL WAS TO DETERMINE THE FEASIBILITY OF RECRUITING PC PATIENTS ON A CLINICAL TRIAL OF YOGA WHILE THEY UNDERWENT EXTERNAL BEAM RADIATION THERAPY (RT). METHODS: TWICE-WEEKLY YOGA INTERVENTIONS WERE OFFERED THROUGHOUT THE RT COURSE (6-9 WEEKS). BASELINE DEMOGRAPHIC INFORMATION WAS COLLECTED. FEASIBILITY WAS DECLARED IF 15 OF THE FIRST 75 ELIGIBLE PC PATIENTS APPROACHED (20%) WERE SUCCESSFULLY ACCRUED AND COMPLETED THE INTERVENTION. ADDITIONAL END POINTS INCLUDED STANDARDIZED ASSESSMENTS OF FATIGUE, ERECTILE DYSFUNCTION (ED), URINARY INCONTINENCE (UI), AND QUALITY OF LIFE (QOL) AT TIME POINTS BEFORE, DURING, AND AFTER RT. RESULTS: BETWEEN MAY 2013 AND JUNE 2014, 68 ELIGIBLE PC PATIENTS WERE IDENTIFIED. 23 PATIENTS (34%) DECLINED, AND 45 (56%) CONSENTED TO THE STUDY. 18 (40%) WERE VOLUNTARILY WITHDRAWN DUE TO TREATMENT CONFLICTS. OF THE REMAINING 27, 12 (30%) PARTICIPATED IN >/=50% OF CLASSES, AND 15 (59%) WERE EVALUABLE. SEVERITY OF FATIGUE SCORES DEMONSTRATED SIGNIFICANT VARIABILITY, WITH FATIGUE INCREASING BY WEEK 4, BUT THEN IMPROVING OVER THE COURSE OF TREATMENT (P = .008). ED, UI, AND GENERAL QOL SCORES DEMONSTRATED REASSURINGLY STABLE, ALBEIT NOT SIGNIFICANT TRENDS. CONCLUSIONS: A STRUCTURED YOGA INTERVENTION OF TWICE-WEEKLY CLASSES IS FEASIBLE FOR PC PATIENTS DURING A 6- TO 9-WEEK COURSE OF OUTPATIENT RADIOTHERAPY. PRELIMINARY RESULTS ARE PROMISING, SHOWING STABLE MEASUREMENTS IN FATIGUE, SEXUAL HEALTH, UI, AND GENERAL QOL. 2016 14 119 49 A PILOT STUDY OF THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. OBJECTIVES: TO DETERMINE THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. DESIGN AND SETTING: IN PART A OF THIS TWO-PART STUDY, ADOLESCENTS WITH SCD AND CHRONIC PAIN (GROUP 1) AND THEIR PARENT (GROUP 2) COMPLETED A SURVEY DESIGNED TO CAPTURE PAIN CHARACTERISTICS, ATTITUDES AND PRACTICES RELATED TO YOGA, AND POTENTIAL ACCEPTABILITY OF A YOGA PROGRAM. IN PART B, THE STUDY ASSESSED THE FEASIBILITY AND SAFETY OF AN INSTRUCTOR-LED GROUP YOGA PROGRAM. THE STUDY WAS REGISTERED ON CLINICALTRIALS.GOV (NCT03694548). INTERVENTION: EIGHT INSTRUCTOR-LED GROUP YOGA SESSIONS. MAIN OUTCOME MEASURES: FEASIBILITY AND SAFETY OUTCOMES WERE CHOSEN A PRIORI, AS FOLLOWS: 1) PROPORTION OF ADOLESCENT PATIENTS WITH SCD AND CHRONIC PAIN APPROACHED THAT CONSENT TO PARTICIPATE IN PART A, 2) PROPORTION OF ADOLESCENT PARTICIPANTS ENROLLED IN PART A THAT CONSENT TO PARTICIPATE IN PART B, 3) PROPORTION OF PARTICIPANTS ENROLLED IN PART B THAT ATTEND AT LEAST 6 OF 8 YOGA SESSIONS, 4) PROPORTION OF PARTICIPANTS ENROLLED IN PART B WITH AN ED VISIT OR A HOSPITALIZATION FOR PAIN WITHIN 24 H OF COMPLETION OF EACH YOGA SESSION, 5) PROPORTION OF PARTICIPANTS IN PART B WHO COMPLETE ALL STUDY ASSESSMENTS BEFORE, AND AT THE END OF THE YOGA PROGRAM, 6) ADHERENCE TO SUBMISSION OF PAIN DIARY. RESULTS: THE MEDIAN AGE OF 15 PATIENT PARTICIPANTS IN PART A WAS 16 (IQR 14-17), AND 14 PARENTS WAS 43.5 (IQR 42-51). MOST PARTICIPANTS WERE FEMALE. MOST PARTICIPANT RESPONSES INDICATED A POSITIVE OPINION OF YOGA. NINE ADOLESCENTS (60 %) FROM PART A PARTICIPATED IN PART B OF THE STUDY. THE MEDIAN AGE OF 9 PARTICIPANTS IN PART B WAS 17 (IQR 15-18), AND 5 OF THE 9 PARTICIPANTS WERE FEMALE (53.3 %). ONLY ONE PARTICIPANT WAS ABLE TO ATTEND 3 OF THE 8 YOGA SESSIONS OFFERED, AND DID NOT EXPERIENCE ANY ED VISITS OR HOSPITALIZATIONS FOLLOWING THE YOGA SESSIONS. NONE OF THE OTHER FEASIBILITY ENDPOINTS WERE MET IN THIS STUDY. CONCLUSIONS: PATIENTS WITH SCD AND CHRONIC PAIN OVERALL HAVE A POSITIVE OPINION OF YOGA, BUT THERE ARE CHALLENGES WITH RECRUITMENT AND RETENTION OF PARTICIPANTS IN A CLINICAL TRIAL OF YOGA, AND BARRIERS TO FEASIBILITY OF AN IN-PERSON GROUP YOGA INTERVENTION. 2021 15 1331 41 HOME-BASED YOGA PROGRAM FOR THE PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA DURING CHEMOTHERAPY: A FEASIBILITY STUDY. BACKGROUND: YOGA IS PROVEN BENEFICIAL IN IMPROVING QUALITY OF LIFE AMONG BREAST CANCER SURVIVORS RECEIVING CHEMOTHERAPY, BUT ITS EFFECTIVENESS IN LYMPHOMA PATIENTS NEEDS TO BE EXPLORED. AS CHEMOTHERAPY-INDUCED NEUTROPENIA IS VERY COMMON AMONG LYMPHOMA PATIENTS, THEY ARE MUCH PRONE TO INFECTIONS FROM THE ENVIRONMENT. FURTHERMORE, TRAINED YOGA INSTRUCTORS ARE NOT AVAILABLE IN EVERY SETTING, SO THERE IS A NEED TO DEVELOP HOME-BASED YOGA PROGRAM MODULES FOR LYMPHOMA PATIENTS RECEIVING CHEMOTHERAPY. AIM: THE AIM OF THE STUDY WAS TO EXPLORE THE FEASIBILITY AND SAFETY OF YOGIC EXERCISES AMONG LYMPHOMA PATIENTS DURING CHEMOTHERAPY. SUBJECTS AND METHODS: AN INTERVENTIONAL, SINGLE-ARM PREPOST DESIGN STUDY WAS CONDUCTED AT A TERTIARY HEALTH-CARE CENTER. PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA (18-65 YEARS) WITH EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS FROM 0 TO 2, PLANNED TO RECEIVE CHEMOTHERAPY WERE ADMINISTERED A HOME-BASED YOGA PROGRAM OVER A PERIOD OF 2 MONTHS FROM THE START OF CHEMOTHERAPY. THE PRIMARY OUTCOME VARIABLES WERE RETENTION RATE, ACCEPTANCE RATE, SAFETY, AND ADHERENCE. HEALTH-RELATED QUALITY OF LIFE (HRQOL), FATIGUE LEVEL, OVERALL SLEEP QUALITY, DEPRESSION, ANXIETY LEVEL, AND PAIN WERE ALSO ASSESSED. STATISTICAL ANALYSIS: DESCRIPTIVE STATISTICS WAS USED TO SEE THE FEASIBILITY AND ADHERENCE. THE PAIRED T-TEST WAS USED TO COMPARE VARIOUS PRE AND POSTINTERVENTION OUTCOME MEASURES. RESULTS: FOURTEEN PATIENTS (MEDIAN AGE: 36 YEARS, RANGE13-65 YEARS) OF MALIGNANT LYMPHOMA WERE ENROLLED IN THE STUDY. MALE-TO-FEMALE RATIO WAS 9:5. NON-HODGKIN'S LYMPHOMA PATIENTS CONSTITUTED 64%. THE RECRUITMENT RATE WAS 93%. FAVORABLE RETENTION (100%), ACCEPTABILITY (97%), ADHERENCE (78.6%), AND NO SERIOUS ADVERSE EVENTS FOLLOWING YOGA PRACTICE WERE REPORTED. IMPROVEMENT WAS ALSO FOUND IN HRQOL, FATIGUE, SLEEP, DEPRESSION, AND ANXIETY. HOWEVER, IT NEEDS FURTHER VALIDATION IN A RANDOMIZED STUDY. CONCLUSION: HOME-BASED YOGA PROGRAM IS SAFE AND FEASIBLE AMONG THE PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA RECEIVING CHEMOTHERAPY. 2018 16 1902 38 RESTORATIVE YOGA IN ADULTS WITH METABOLIC SYNDROME: A RANDOMIZED, CONTROLLED PILOT TRIAL. BACKGROUND: METABOLIC SYNDROME INCREASES THE RISK OF DIABETES AND CARDIOVASCULAR DISEASE. YOGA IMPROVES SOME METABOLIC PARAMETERS, BUT IT HAS NOT BEEN STUDIED IN PERSONS WITH METABOLIC SYNDROME. WE CONDUCTED A RANDOMIZED CONTROLLED PILOT TRIAL TO DETERMINE WHETHER A RESTORATIVE YOGA INTERVENTION WAS FEASIBLE AND ACCEPTABLE IN UNDERACTIVE, OVERWEIGHT ADULTS WITH METABOLIC SYNDROME. METHODS: TWENTY SIX UNDERACTIVE, OVERWEIGHT ADULT MEN AND WOMEN WITH METABOLIC SYNDROME WERE RANDOMIZED TO ATTEND 15 YOGA SESSIONS OF 90 MINUTES EACH OVER 10 WEEKS OR TO A WAIT-LIST CONTROL GROUP. FEASIBILITY WAS MEASURED BY RECRUITMENT RATES, SUBJECT RETENTION, AND ADHERENCE. ACCEPTABILITY WAS ASSESSED BY INTERVIEW AND QUESTIONNAIRES. CHANGES IN METABOLIC OUTCOMES AND QUESTIONNAIRE MEASURES FROM BASELINE TO WEEK 10 WERE CALCULATED. RESULTS: A TOTAL OF 280 PEOPLE WERE SCREENED BY PHONE, AND 93 WITH HIGH LIKELIHOOD OF METABOLIC SYNDROME WERE INVITED TO A SCREENING VISIT. OF THE 68 WHO ATTENDED SCREENING VISITS, 26 (38%) WERE RANDOMIZED, AND 24 (92%) COMPLETED THE TRIAL. ATTENDANCE AT YOGA CLASSES AND ADHERENCE TO HOME PRACTICE EXCEEDED OUR GOALS. IN THE YOGA GROUP, ALL PARTICIPANTS GAVE THE STUDY THE HIGHEST POSSIBLE SATISFACTION RATING, AND THE MAJORITY (87%) FELT THAT THE YOGA POSES WERE EASY TO PERFORM. THERE WAS TREND TO REDUCED BLOOD PRESSURE (P = 0.07), A SIGNIFICANT INCREASE IN ENERGY LEVEL (P < 0.009), AND TRENDS TO IMPROVEMENT IN WELL-BEING (P < 0.12) AND STRESS (P < 0.22) IN THE YOGA VERSUS CONTROL GROUP. CONCLUSIONS: RESTORATIVE YOGA WAS A FEASIBLE AND ACCEPTABLE INTERVENTION IN OVERWEIGHT ADULTS WITH METABOLIC SYNDROME. THE EFFICACY OF YOGA FOR IMPROVING METABOLIC PARAMETERS IN THIS POPULATION SHOULD BE EXPLORED IN A LARGER RANDOMIZED CONTROLLED TRIAL. 2008 17 1243 44 FEASIBILITY OF A YOGA, AEROBIC AND STRETCHING-TONING EXERCISE PROGRAM FOR ADULT CANCER SURVIVORS: THE STAYFIT TRIAL. BACKGROUND: THE USE OF YOGA AS A MIND-BODY PRACTICE HAS BECOME INCREASINGLY POPULAR AMONG CLINICAL POPULATIONS AND OLDER ADULTS WHO USE THIS PRACTICE TO MANAGE AGE AND CHRONIC DISEASE-RELATED SYMPTOMS. ALTHOUGH YOGA CONTINUES TO GAIN POPULARITY AMONG PRACTITIONERS AND RESEARCHERS, PILOT STUDIES THAT EXAMINE ITS FEASIBILITY AND ACCEPTABILITY, ESPECIALLY AMONG CANCER SURVIVORS, ARE LIMITED. FEASIBILITY STUDIES PLAY A CRITICAL ROLE IN DETERMINING WHETHER THE TARGET POPULATION IS LIKELY TO ENGAGE WITH LARGER SCALE EFFICACY AND EFFECTIVENESS TRIALS. IN THIS PAPER WE PRESENT FEASIBILITY AND ACCEPTABILITY DATA FROM A 12-WEEK RANDOMIZED CONTROLLED TRIAL (RCT) CONDUCTED WITH ADULT CANCER SURVIVORS. METHODS: PARTICIPANTS N = 78 (MEAN AGE: 55 YEARS) WERE RANDOMIZED TO ONE OF THREE GROUPS: A HATHA YOGA, AEROBIC EXERCISE, OR STRETCHING-TONING CONTROL GROUP WITH GROUP EXERCISE CLASSES HELD FOR 150 MIN/WEEK FOR 12 WEEKS. HEREIN WE REPORT FEASIBILITY AND ACCEPTABILITY, INCLUDING ENROLLMENT RATES, ATTENDANCE, ATTRITION AND ADVERSE EVENTS, AND PARTICIPANT FEEDBACK AND SATISFACTION DATA. RESULTS: OF THE 233 ADULTS SCREENED, 109 WERE ELIGIBLE AND 78 RANDOMIZED TO ONE OF THE THREE INTERVENTION ARMS. SESSION ATTENDANCE WAS HIGH FOR ALL GROUPS (75.5-89.5%) AND 17 PARTICIPANTS DROPPED OUT DURING THE 12-WEEK INTERVENTION. PROGRAM SATISFACTION WAS HIGH (4.8 OR HIGHER OUT OF 5) AND NO ADVERSE EVENTS WERE REPORTED. ONE COHORT (N = 15) OF THE INTERVENTION TRANSITIONED TO REMOTE INTERVENTION DELIVERY DUE TO THE COVID-19 PANDEMIC. FEASIBILITY DATA FROM THESE PARTICIPANTS SUGGESTED THAT SYNCHRONIZED GROUP EXERCISE CLASSES VIA ZOOM WITH A LIVE INSTRUCTOR WERE ACCEPTABLE AND ENJOYABLE. PARTICIPANT FEEDBACK REGARDING MOST AND LEAST HELPFUL ASPECTS OF THE PROGRAM AS WELL AS SUGGESTIONS FOR FUTURE YOGA INTERVENTIONS ARE SUMMARIZED. CONCLUSIONS: OVERALL, THE YOGA INTERVENTION WAS HIGHLY FEASIBLE AND ACCEPTABLE. THE FEASIBILITY PARAMETERS FROM THIS TRIAL CAN AID RESEARCHERS IN ESTIMATING RECRUITMENT RATES FOR DESIRED SAMPLE SIZES TO SUCCESSFULLY RANDOMIZE AND RETAIN CANCER SURVIVORS IN SHORT- AND LONG-TERM YOGA-BASED EFFICACY AND EFFECTIVENESS TRIALS. THE FINDINGS ALSO PROVIDE EVIDENCE TO CLINICIANS WHO CAN RECOMMEND UP TO 150 MIN OF A COMBINATION OF EXERCISES-AEROBIC, YOGA, OR STRETCHING-TONING TO THEIR CANCER PATIENTS IN ORDER TO IMPROVE HEALTH AND WELLBEING DURING CANCER SURVIVORSHIP. 2021 18 282 44 ADHERENCE TO YOGA AND EXERCISE INTERVENTIONS IN A 6-MONTH CLINICAL TRIAL. BACKGROUND: TO DETERMINE FACTORS THAT PREDICT ADHERENCE TO A MIND-BODY INTERVENTION IN A RANDOMIZED TRIAL. DESIGN: WE ANALYZED ADHERENCE DATA FROM A 3-ARM TRIAL INVOLVING 135 GENERALLY HEALTHY SENIORS 65-85 YEARS OF AGE RANDOMIZED TO A 6-MONTH INTERVENTION CONSISTING OF: AN IYENGAR YOGA CLASS WITH HOME PRACTICE, AN EXERCISE CLASS WITH HOME PRACTICE, OR A WAIT-LIST CONTROL GROUP. OUTCOME MEASURES INCLUDED COGNITIVE FUNCTION, MOOD, FATIGUE, ANXIETY, HEALTH-RELATED QUALITY OF LIFE, AND PHYSICAL MEASURES. ADHERENCE TO THE INTERVENTION WAS OBTAINED BY CLASS ATTENDANCE AND BIWEEKLY HOME PRACTICE LOGS. RESULTS: THE DROP-OUT RATE WAS 13%. AMONG THE COMPLETERS OF THE TWO ACTIVE INTERVENTIONS, AVERAGE YOGA CLASS ATTENDANCE WAS 77% AND HOME PRACTICE OCCURRED 64% OF ALL DAYS. AVERAGE EXERCISE CLASS ATTENDANCE WAS 69% AND HOME EXERCISE OCCURRED 54% OF ALL DAYS. THERE WERE NO CLEAR EFFECTS OF ADHERENCE ON THE SIGNIFICANT STUDY OUTCOMES (QUALITY OF LIFE AND PHYSICAL MEASURES). CLASS ATTENDANCE WAS SIGNIFICANTLY CORRELATED WITH BASELINE MEASURES OF DEPRESSION, FATIGUE, AND PHYSICAL COMPONENTS OF HEALTH-RELATED QUALITY OF LIFE. SIGNIFICANT DIFFERENCES IN BASELINE MEASURES WERE ALSO FOUND BETWEEN STUDY COMPLETERS AND DROP-OUTS IN THE ACTIVE INTERVENTIONS. ADHERENCE WAS NOT RELATED TO AGE, GENDER, OR EDUCATION LEVEL. CONCLUSION: HEALTHY SENIORS HAVE GOOD ATTENDANCE AT CLASSES WITH A PHYSICALLY ACTIVE INTERVENTION. HOME PRACTICE TAKES PLACE OVER HALF OF THE TIME. DECREASED ADHERENCE TO A POTENTIALLY BENEFICIAL INTERVENTION HAS THE POTENTIAL TO DECREASE THE EFFECT OF THE INTERVENTION IN A CLINICAL TRIAL BECAUSE SUBJECTS WHO MIGHT SUSTAIN THE GREATEST BENEFIT WILL RECEIVE A LOWER DOSE OF THE INTERVENTION AND SUBJECTS WITH HIGHER ADHERENCE RATES MAY BE FUNCTIONING CLOSER TO MAXIMUM ABILITY BEFORE THE INTERVENTION. STRATEGIES TO MAXIMIZE ADHERENCE AMONG SUBJECTS AT GREATER RISK FOR LOW ADHERENCE WILL BE IMPORTANT FOR FUTURE TRIALS, ESPECIALLY COMPLEMENTARY TREATMENTS REQUIRING GREATER EFFORT THAN SIMPLE PILL-TAKING. 2007 19 1681 28 ONLINE ISHA UPA YOGA FOR STUDENT MENTAL HEALTH AND WELL-BEING DURING COVID-19: A RANDOMIZED CONTROL TRIAL. COLLEGE STUDENTS EXPERIENCED INCREASED STRESS AND ANXIETY DURING THE COVID-19 PANDEMIC. THIS STUDY EVALUATED THE EFFECT OF BRIEF ONLINE ISHA UPA YOGA MODULES ON UNDERGRADUATES' MENTAL HEALTH AND WELL-BEING. RANDOMIZED CONTROL TRIAL (RCT) WITH WAITLIST CONTROL CROSSOVER (N = 679). THE INTERVENTION GROUP WAS INSTRUCTED TO LEARN AND PRACTICE THE MODULES DAILY FOR 12 WEEKS. AT THE END OF THE 4-WEEK RCT, THE CONTROL GROUP WAS INSTRUCTED TO LEARN AND PRACTICE THE MODULES FOR THE REMAINING 8 WEEKS. PRIMARY OUTCOMES INCLUDED STRESS AND WELL-BEING. SECONDARY OUTCOMES INCLUDED ANXIETY, DEPRESSION, RESILIENCE, POSITIVE AFFECT AND NEGATIVE AFFECT. LINEAR MIXED-EFFECTS MODELS WERE USED FOR ANALYSES. ISHA UPA YOGA SIGNIFICANTLY REDUCED STRESS (GROUP [INTERVENTION, CONTROL] X TIME [BASELINE, WEEK 4] INTERACTION, P = .009, D = .27) AND INCREASED WELL-BEING (GROUP X TIME INTERACTION P = .002, D = .32). BY THE STUDY'S END, THE INTERVENTION AND CONTROL GROUPS EXPERIENCED SIGNIFICANT IMPROVEMENTS IN WELL-BEING (P < .001, P < .001), STRESS (P < .001, P < .001), ANXIETY (P < .001, P < .001), DEPRESSION (P < .001, P = .004), POSITIVE AFFECT (P = .04, P < .001), AND NEGATIVE AFFECT (P < .001, P < .001). ONLINE ISHA UPA YOGA SHOWS PROMISE FOR MITIGATING THE PANDEMIC'S NEGATIVE IMPACT ON UNDERGRADUATES' MENTAL HEALTH AND IMPROVING THEIR WELL-BEING. 2022 20 1859 39 RANDOMIZED CONTROLLED PILOT TRIAL OF YOGA IN OVERWEIGHT AND OBESE BREAST CANCER SURVIVORS: EFFECTS ON QUALITY OF LIFE AND ANTHROPOMETRIC MEASURES. PURPOSE: TO OBTAIN ESTIMATES OF TIME TO RECRUIT THE STUDY SAMPLE, RETENTION, FACILITY-BASED CLASS ATTENDANCE AND HOME PRACTICE FOR A STUDY OF YOGA IN BREAST CANCER SURVIVORS, AND ITS EFFICACY ON FATIGUE, QUALITY OF LIFE (QOL), AND WEIGHT CHANGE. METHODS: SIXTY-THREE POST-TREATMENT STAGES 0-III BORDERLINE OVERWEIGHT AND OBESE (BODY MASS INDEX >/= 24 KG/M(2)) BREAST CANCER SURVIVORS WERE RANDOMLY ASSIGNED TO A 6-MONTH, FACILITY- AND HOME-BASED VINIYOGA INTERVENTION (N = 32) OR A WAITLIST CONTROL GROUP (N = 31). THE YOGA GOAL WAS FIVE PRACTICES PER WEEK. PRIMARY OUTCOME MEASURES WERE CHANGES IN QOL, FATIGUE, AND WEIGHT FROM BASELINE TO 6 MONTHS. SECONDARY OUTCOMES INCLUDED CHANGES IN WAIST AND HIP CIRCUMFERENCE. RESULTS: IT TOOK 12 MONTHS TO COMPLETE RECRUITMENT. PARTICIPANTS ATTENDED A MEAN OF 19.6 CLASSES AND PRACTICED AT HOME A MEAN OF 55.8 TIMES DURING THE 6-MONTH PERIOD. AT FOLLOW-UP, 90% OF PARTICIPANTS COMPLETED QUESTIONNAIRES AND 87% COMPLETED ANTHROPOMETRIC MEASUREMENTS. QOL AND FATIGUE IMPROVED TO A GREATER EXTENT AMONG WOMEN IN THE YOGA GROUP RELATIVE TO WOMEN IN THE CONTROL GROUP, ALTHOUGH NO DIFFERENCES WERE STATISTICALLY SIGNIFICANT. WAIST CIRCUMFERENCE DECREASED 3.1 CM (95% CI, -5.7 AND -0.4) MORE AMONG WOMEN IN THE YOGA COMPARED WITH THE CONTROL GROUP, WITH NO DIFFERENCE IN WEIGHT CHANGE. CONCLUSIONS: THIS STUDY PROVIDES IMPORTANT INFORMATION REGARDING RECRUITMENT, RETENTION, AND PRACTICE LEVELS ACHIEVED DURING A 6-MONTH, INTENSIVE YOGA INTERVENTION IN OVERWEIGHT AND OBESE BREAST CANCER SURVIVORS. YOGA MAY HELP DECREASE WAIST CIRCUMFERENCE AND IMPROVE QUALITY OF LIFE; FUTURE STUDIES ARE NEEDED TO CONFIRM THESE RESULTS. 2012