1 1165 234 EVALUATING THE FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES IN PEOPLE LIVING WITH HIV: PROTOCOL FOR A RANDOMIZED PILOT TRIAL. BACKGROUND: DESPITE LOWER MORTALITY RATES DUE TO COMBINATION ANTIRETROVIRAL THERAPY, PEOPLE LIVING WITH HIV (PLWH) ARE GRAPPLING WITH INCREASINGLY COMPLEX HEALTH ISSUES, INCLUDING COGNITIVE IMPAIRMENTS IN AREAS SUCH AS MEMORY, ATTENTION, PROCESSING SPEED, AND MOTOR FUNCTION. YOGA HAS BEEN SHOWN TO BE AN EFFECTIVE FORM OF EXERCISE AND MINDFULNESS-BASED STRESS REDUCTION FOR MANY CLINICAL POPULATIONS. HOWEVER, NO RANDOMIZED TRIALS HAVE EVALUATED THE IMPACT OF YOGA ON COGNITIVE AND PHYSICAL FUNCTION AMONG PLWH. OBJECTIVE: THE AIM OF THIS PILOT RANDOMIZED TRIAL WAS TO DETERMINE THE FEASIBILITY OF A YOGA INTERVENTION TO LAY THE GROUNDWORK FOR A FULL-SCALE, MULTISITE, COMMUNITY-BASED TRIAL FOR PLWH. SPECIFIC OBJECTIVES ARE TO (1) ASSESS THE FEASIBILITY OF STUDY PROTOCOL AND PROCEDURES, (2) COMPARE COGNITION IN THE YOGA GROUP WITH THE USUAL CARE CONTROL GROUP AFTER 12 WEEKS OF THE INTERVENTION IN PLWH, AND (3) COMPARE THE EFFECTS OF THE 12-WEEK YOGA INTERVENTION VERSUS CONTROL ON BALANCE, WALKING SPEED, PHYSICAL ACTIVITY, MENTAL HEALTH, MEDICATION ADHERENCE, AND QUALITY OF LIFE AMONG PLWH. METHODS: WE PROPOSE A PILOT RANDOMIZED TRIAL WITH 2 PARALLEL GROUPS (YOGA VERSUS CONTROL). WE WILL RECRUIT 25 PLWH (>35 YEARS) FROM COMMUNITY AND HEALTH ORGANIZATIONS IN HALIFAX, CANADA. AFTER BASELINE ASSESSMENT WITH BLINDED ASSESSORS, PARTICIPANTS WILL BE RANDOMLY ASSIGNED TO THE YOGA OR CONTROL GROUP, USING A RANDOM COMPUTER GENERATOR. PARTICIPANTS IN THE YOGA GROUP WILL ENGAGE IN SUPERVISED 60-MIN GROUP-BASED YOGA SESSIONS 3 TIMES A WEEK FOR 12 WEEKS AT A YOGA STUDIO. PARTICIPANTS IN THE CONTROL GROUP WILL MAINTAIN THEIR CURRENT PHYSICAL ACTIVITY LEVELS THROUGHOUT THE STUDY. RESULTS: AS PER THE CONSOLIDATED STANDARDS OF REPORTING TRIALS EXTENSION FOR PILOT STUDIES, MEANS OF ALL OUTCOMES, MEAN CHANGE, AND 95% CIS WILL BE CALCULATED FOR EACH GROUP SEPARATELY. TWO-TAILED INDEPENDENT T TESTS AND FISHER EXACT TESTS WILL BE USED TO COMPARE GROUPS AT BASELINE. WE WILL ANALYZE QUANTITATIVE POSTINTERVENTION QUESTIONNAIRE RESPONSES USING CHI-SQUARE TESTS, AND OPEN-ENDED RESPONSES WILL BE ANALYZED THEMATICALLY. INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSES WILL BE USED TO ANALYZE SECONDARY VARIABLES. CHANGES IN OUTCOME VARIABLES WILL BE EXAMINED BETWEEN GROUPS AND WITHIN GROUPS. EFFECT SIZES WILL BE REPORTED FOR EACH OUTCOME. A PRIORI ADHERENCE AND SATISFACTION CRITERIA WILL BE MET IF PARTICIPANTS ATTEND >70% OF THE YOGA SESSIONS AND IF >70% OF THE PARTICIPANTS ARE SATISFIED WITH THE INTERVENTION AS DETERMINED BY A POSTPARTICIPATION QUESTIONNAIRE. STUDY ENROLLMENT BEGAN IN JANUARY 2018, WITH RESULTS EXPECTED FOR OCTOBER 2019. CONCLUSIONS: THIS PILOT RANDOMIZED TRIAL WILL BE THE FIRST TO INVESTIGATE THE FEASIBILITY AND EFFECT OF A YOGA INTERVENTION ON COGNITIVE AND PHYSICAL OUTCOMES AMONG PLWH. THIS WORK WILL INFORM THE FEASIBILITY OF FURTHER INVESTIGATIONS IN TERMS OF CAPACITY BUILDING, PARTICIPANT RECRUITMENT AND RETENTION, AND ASSESSMENT AND INTERVENTION PROTOCOLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03071562; HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03071562 (ARCHIVED BY WEBCITE AT HTTP://WWW.WEBCITATION.ORG/785SFHWKW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13818. 2019 2 1228 65 FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES AMONG PEOPLE LIVING WITH HIV: A RANDOMIZED CONTROLLED PILOT TRIAL. THE PURPOSE OF THIS PILOT RANDOMIZED CONTROLLED TRIAL IS TO ASSESS THE FEASIBILITY AND IMPACT OF A TRIWEEKLY 12-WEEK YOGA INTERVENTION AMONG PEOPLE LIVING WITH HIV (PLWH). ADDITIONAL OBJECTIVES INCLUDED EVALUATING COGNITION, PHYSICAL FUNCTION, MEDICATION ADHERENCE, HEALTH-RELATED QUALITY OF LIFE (HRQOL), AND MENTAL HEALTH AMONG YOGA PARTICIPANTS VERSUS CONTROLS USING BLINDED ASSESSORS. WE RECRUITED 22 MEDICALLY STABLE PLWH AGED >/=35 YEARS. A PRIORI FEASIBILITY CRITERIA WERE >/=70% YOGA SESSION ATTENDANCE AND >/=70% OF PARTICIPANTS SATISFIED WITH THE INTERVENTION USING A POSTPARTICIPATION QUESTIONNAIRE. TWO PARTICIPANTS WITHDREW FROM THE YOGA GROUP. MEAN YOGA CLASS ATTENDANCE WAS 82%, WITH 100% SATISFACTION. INTENTION-TO-TREAT ANALYSES (YOGA N = 11, CONTROL N = 11) SHOWED NO WITHIN- OR BETWEEN-GROUP DIFFERENCES IN COGNITIVE AND PHYSICAL FUNCTION. THE YOGA GROUP IMPROVED OVER TIME IN HRQOL COGNITION (P = .047) WITH TRENDS TOWARD IMPROVEMENTS IN HRQOL HEALTH TRANSITION (P =.063) AND DEPRESSION (P = .055). THIS PILOT STUDY PROVIDES PRELIMINARY EVIDENCE OF FEASIBILITY AND BENEFITS OF YOGA FOR PLWH. 2020 3 2811 55 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 4 1242 66 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 5 2628 60 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 6 282 54 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 7 1243 59 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 8 2222 60 THE IMPACT OF MODIFIED HATHA YOGA ON CHRONIC LOW BACK PAIN: A PILOT STUDY. PURPOSE: THE PURPOSE OF THIS RANDOMIZED PILOT STUDY WAS TO EVALUATE A POSSIBLE DESIGN FOR A 6-WEEK MODIFIED HATHA YOGA PROTOCOL TO STUDY THE EFFECTS ON PARTICIPANTS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS: TWENTY-TWO PARTICIPANTS (M = 4; F = 17), BETWEEN THE AGES OF 30 AND 65, WITH CHRONIC LOW BACK PAIN (CLBP) WERE RANDOMIZED TO EITHER AN IMMEDIATE YOGA BASED INTERVENTION, OR TO A CONTROL GROUP WITH NO TREATMENT DURING THE OBSERVATION PERIOD BUT RECEIVED LATER YOGA TRAINING. METHODS: A SPECIFIC CLBP YOGA PROTOCOL DESIGNED AND MODIFIED FOR THIS POPULATION BY A CERTIFIED YOGA INSTRUCTOR WAS ADMINISTERED FOR ONE HOUR, TWICE A WEEK FOR 6 WEEKS. PRIMARY FUNCTIONAL OUTCOME MEASURES INCLUDED THE FORWARD REACH (FR) AND SIT AND REACH (SR) TESTS. ALL PARTICIPANTS COMPLETED OSWESTRY DISABILITY INDEX (ODI) AND BECK DEPRESSION INVENTORY (BDI) QUESTIONNAIRES. GUIDING QUESTIONS WERE USED FOR QUALITATIVE DATA ANALYSIS TO ASCERTAIN HOW YOGA PARTICIPANTS PERCEIVED THE INSTRUCTOR, GROUP DYNAMICS, AND THE IMPACT OF YOGA ON THEIR LIFE. ANALYSIS: TO ACCOUNT FOR DROP OUTS, THE DATA WERE DIVIDED INTO BETTER OR NOT CATEGORIES, AND ANALYZED USING CHI-SQUARE TO EXAMINE DIFFERENCES BETWEEN THE GROUPS. QUALITATIVE DATA WERE ANALYZED THROUGH FREQUENCY OF POSITIVE RESPONSES. RESULTS: POTENTIALLY IMPORTANT TRENDS IN THE FUNCTIONAL MEASUREMENT SCORES SHOWED IMPROVED BALANCE AND FLEXIBILITY AND DECREASED DISABILITY AND DEPRESSION FOR THE YOGA GROUP BUT THIS PILOT WAS NOT POWERED TO REACH STATISTICAL SIGNIFICANCE. SIGNIFICANT LIMITATIONS INCLUDED A HIGH DROPOUT RATE IN THE CONTROL GROUP AND LARGE BASELINE DIFFERENCES IN THE SECONDARY MEASURES. IN ADDITION, ANALYSIS OF THE QUALITATIVE DATA REVEALED THE FOLLOWING FREQUENCY OF RESPONSES (1) GROUP INTERVENTION MOTIVATED THE PARTICIPANTS AND (2) YOGA FOSTERED RELAXATION AND NEW AWARENESS/LEARNING. CONCLUSION: A MODIFIED YOGA-BASED INTERVENTION MAY BENEFIT INDIVIDUALS WITH CLB, BUT A LARGER STUDY IS NECESSARY TO PROVIDE DEFINITIVE EVIDENCE. ALSO, THE IMPACT ON DEPRESSION AND DISABILITY COULD BE CONSIDERED AS IMPORTANT OUTCOMES FOR FURTHER STUDY. ADDITIONAL FUNCTIONAL OUTCOME MEASURES SHOULD BE EXPLORED. THIS PILOT STUDY SUPPORTS THE NEED FOR MORE RESEARCH INVESTIGATING THE EFFECT OF YOGA FOR THIS POPULATION. 2004 9 2194 65 THE EFFECTS OF YOGA VERSUS STRETCHING AND RESISTANCE TRAINING EXERCISES ON PSYCHOLOGICAL DISTRESS FOR PEOPLE WITH MILD-TO-MODERATE PARKINSON'S DISEASE: STUDY PRXOTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: PSYCHOLOGICAL DISTRESS IS PREVALENT AMONG PEOPLE WITH PARKINSON'S DISEASE (PD) AND AGGRAVATES THEIR MOTOR SYMPTOMS, THEREBY LEADING TO INCREASED DISABILITY, HIGH HEALTHCARE COSTS, AND POOR HEALTH-RELATED QUALITY OF LIFE (HRQOL). THE UNDER-RECOGNITION AND ADVERSE EFFECTS OF THE PHARMACOLOGICAL MANAGEMENT OF ANXIETY AND DEPRESSION AMONG THE PD POPULATION ARE CONSIDERABLE. THUS, ADOPTING A COMPLEMENTARY AND ALTERNATIVE MANAGEMENT (CAM) APPROACH TO ADDRESS THIS PROBLEM IS IMPORTANT. YOGA, ONE OF THE MOST COMMON "MIND-BODY" CAM THERAPIES, CAN IMPROVE THE PSYCHOLOGICAL WELLBEING OF PEOPLE WITH CHRONIC ILLNESSES. HOWEVER, LIMITED RESEARCH ON THE EFFECTS OF YOGA IN PEOPLE WITH PD HAS BEEN CONDUCTED. THIS STUDY WILL DETERMINE THE EFFECTS OF YOGA ON THE PSYCHOLOGICAL WELLBEING OF PEOPLE WITH MILD-TO-MODERATE PD AND WILL COMPARE THESE EFFECTS WITH THOSE OF STRETCHING AND RESISTANCE TRAINING EXERCISES. METHODS: A COMMUNITY-BASED, SINGLE-BLIND, RANDOMIZED TRIAL WILL BE CONDUCTED. A TOTAL OF 126 SUBJECTS WILL BE RECRUITED AND RANDOMLY DIVIDED INTO YOGA (N = 63) OR STRETCHING AND RESISTANCE EXERCISE (N = 63) GROUPS. FOR 8 WEEKS, THE YOGA GROUP WILL RECEIVE A WEEKLY 90-MIN SESSION OF YOGA, AND THE CONTROL GROUP WILL RECEIVE A WEEKLY 60-MIN SESSION OF STRETCHING AND RESISTANCE EXERCISES. THE PRIMARY OUTCOME WILL BE THE LEVEL OF PSYCHOLOGICAL DISTRESS MEASURED USING THE HOSPITAL ANXIETY AND DEPRESSION SCALE. THE SECONDARY OUTCOMES WILL INCLUDE THE SEVERITY OF MOTOR SYMPTOMS MEASURED BY THE MOVEMENT DISORDERS SOCIETY - UNIFIED PARKINSON'S DISEASE SCALE - PART III MOTOR EXAMINATION; MOBILITY, BALANCE, AND FALL RISK MEASURED BY THE TIMED UP AND GO TEST; SPIRITUAL WELLBEING MEASURED BY THE HOLISTIC WELLBEING SCALE; AND HRQOL MEASURED BY THE PARKINSON'S DISEASE QUESTIONNAIRE-8. ASSESSMENT WILL BE CONDUCTED AT BASELINE, 8TH, AND 20TH WEEKS OF FOLLOW-UPS. DISCUSSION: THIS STUDY WILL BE THE FIRST RANDOMIZED TRIAL TO COMPARE THE EFFECT OF YOGA VERSUS STRETCHING AND RESISTANCE TRAINING EXERCISES IN A PD POPULATION. RESULTS WILL CONTRIBUTE TO THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR MANAGING PSYCHOLOGICAL DISTRESS IN PD PATIENTS. MULTIPLE OUTCOMES INCLUDING PSYCHOLOGICAL, PHYSIOLOGICAL, AND SPIRITUAL AND HRQOL WILL ALSO BE MEASURED TO ELUCIDATE THE POTENTIAL MECHANISMS OF YOGA. THE EFFECT OF YOGA ON PEOPLE WITH CHRONIC ILLNESSES WILL FURTHER BE ELUCIDATED. THIS INFORMATION SHOULD CONTRIBUTE TO FUTURE RESEARCH, PRACTICE, AND POLICY RELATED TO PD MANAGEMENT. TRIAL REGISTRATION: WHO PRIMARY REGISTRY - CHINESE CLINICAL TRIALS REGISTRY (CHICTR): CUHK_CCRB00522 REGISTERED ON 8 OCTOBER 2016; DATE OF APPROVAL 19 AUGUST 2016. 2017 10 345 52 ASSESSING FEASIBILITY AND ACCEPTABILITY OF YOGA AND GROUP CBT FOR ADOLESCENTS WITH DEPRESSION: A PILOT RANDOMIZED CLINICAL TRIAL. PURPOSE: GIVEN INCREASING RATES OF DEPRESSION IN ADOLESCENTS, THERE IS A CLEAR NEED FOR INNOVATIVE TREATMENTS. IN THIS PILOT RANDOMIZED CLINICAL TRIAL, WE ASSESSED ACCEPTABILITY AND FEASIBILITY OF TWO GROUP-BASED INTERVENTIONS: YOGA AND COGNITIVE-BEHAVIORAL THERAPY (CBT). THE GOAL OF THIS WORK IS TO PREPARE FOR A FUTURE FULLY POWERED RANDOMIZED TRIAL TO TEST THE HYPOTHESIS THAT YOGA IS NOT INFERIOR TO AN ESTABLISHED ADOLESCENT DEPRESSION TREATMENT, NAMELY, GROUP CBT. METHODS: WE ENROLLED 42 ADOLESCENTS WITH ELEVATED DEPRESSION SYMPTOMS. PARTICIPANTS WERE RANDOMLY ASSIGNED TO A 12-WEEK GROUP-BASED INTERVENTION, YOGA OR CBT. WE HAD A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS, INCLUDING FOR RECRUITMENT RATE, RETENTION RATE, EXPECTANCY, CREDIBILITY, PROGRAM SATISFACTION, CLASS ATTENDANCE, ENGAGEMENT IN HOME PRACTICE, AND INSTRUCTOR/LEADER MANUAL ADHERENCE. WE ASSESSED ADVERSE EVENTS, AND WITHIN-SUBJECT CHANGES IN OUTCOMES (DEPRESSION, ANXIETY, IMPAIRMENT, SLEEP DISTURBANCE) AND POSSIBLE MEDIATORS (MINDFULNESS, SELF-COMPASSION). RESULTS: BOTH INTERVENTIONS MET MOST ACCEPTABILITY AND FEASIBILITY TARGETS. THE ONLY TARGET NOT MET RELATED TO LOW ENGAGEMENT IN HOME PRACTICE. PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS OVER TIME AND INCREASED SELF-COMPASSION. CONCLUSIONS: A YOGA INTERVENTION APPEARS TO BE ACCEPTABLE AND FEASIBLE TO ADOLESCENTS WITH DEPRESSION. HOWEVER, IT MAY BE CHALLENGING FOR THIS GROUP TO ENGAGE IN UNSTRUCTURED HOME PRACTICE. 2022 11 1617 65 MINDFUL YOGA FOR WOMEN WITH METASTATIC BREAST CANCER: DESIGN OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: WOMEN WITH METASTATIC BREAST CANCER (MBC) HAVE AVERAGE LIFE EXPECTANCIES OF ABOUT 2 YEARS, AND REPORT HIGH LEVELS OF DISEASE-RELATED SYMPTOMS INCLUDING PAIN, FATIGUE, SLEEP DISTURBANCE, PSYCHOLOGICAL DISTRESS, AND FUNCTIONAL IMPAIRMENT. THERE IS GROWING RECOGNITION OF THE LIMITATIONS OF MEDICAL APPROACHES TO MANAGING SUCH SYMPTOMS. YOGA IS A MIND-BODY DISCIPLINE THAT HAS DEMONSTRATED A POSITIVE IMPACT ON PSYCHOLOGICAL AND FUNCTIONAL HEALTH IN EARLY STAGE BREAST CANCER PATIENTS AND SURVIVORS, BUT HAS NOT BEEN RIGOROUSLY STUDIED IN ADVANCED CANCER SAMPLES. METHODS: THIS RANDOMIZED CONTROLLED TRIAL EXAMINES THE FEASIBILITY AND INITIAL EFFICACY OF A MINDFUL YOGA PROGRAM, COMPARED WITH A SOCIAL SUPPORT CONDITION THAT CONTROLS FOR ATTENTION, ON MEASURES OF DISEASE-RELATED SYMPTOMS SUCH AS PAIN AND FATIGUE. THE STUDY WILL BE COMPLETED BY DECEMBER 2017. SIXTY-FIVE WOMEN WITH MBC AGE >/= 18 ARE BEING IDENTIFIED AND RANDOMIZED WITH A 2:1 ALLOCATION TO MINDFUL YOGA OR A SUPPORT GROUP CONTROL INTERVENTION. THE 120-MIN INTERVENTION SESSIONS TAKE PLACE WEEKLY FOR 8 WEEKS. THE STUDY IS CONDUCTED AT AN URBAN TERTIARY CARE ACADEMIC MEDICAL CENTER LOCATED IN DURHAM, NORTH CAROLINA. THE PRIMARY FEASIBILITY OUTCOME IS ATTENDANCE AT INTERVENTION SESSIONS. EFFICACY OUTCOMES INCLUDE PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS AND FUNCTIONAL CAPACITY AT POST-INTERVENTION, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. DISCUSSION: IN THIS ARTICLE, WE PRESENT THE CHALLENGES OF DESIGNING A RANDOMIZED CONTROLLED TRIAL WITH LONG-TERM FOLLOW-UP AMONG WOMEN WITH MBC. THESE CHALLENGES INCLUDE ENSURING ADEQUATE RECRUITMENT INCLUDING OF MINORITIES, LIMITING AND CONTROLLING FOR SELECTION BIAS, TAILORING OF THE YOGA INTERVENTION TO ADDRESS SPECIAL NEEDS, AND MAXIMIZING ADHERENCE AND RETENTION. THIS PROJECT WILL PROVIDE IMPORTANT INFORMATION REGARDING YOGA AS AN INTERVENTION FOR WOMEN WITH ADVANCED CANCER, INCLUDING PRELIMINARY DATA ON THE PSYCHOLOGICAL AND FUNCTIONAL EFFECTS OF YOGA FOR MBC PATIENTS. THIS INVESTIGATION WILL ALSO ESTABLISH RIGOROUS METHODS FOR FUTURE RESEARCH INTO YOGA AS AN INTERVENTION FOR THIS POPULATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFER: NCT01927081 , REGISTERED AUGUST 16, 2013. 2017 12 175 48 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 13 1106 59 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 14 1240 49 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 15 2609 64 YOGA FOR QUALITY OF LIFE IN INDIVIDUALS WITH CHRONIC DISEASE: A SYSTEMATIC REVIEW. BACKGROUND: CHRONIC DISEASES, INCLUDING HEART DISEASE, STROKE, CANCER, AND CHRONIC PULMONARY DISEASE ARE THE LEADING CAUSES OF DEATH AND DISABILITY WORLDWIDE. COMPOUNDING SYMPTOMS AND LOSS OF FUNCTION, PEOPLE LIVING WITH CHRONIC DISEASE OFTEN EXPERIENCE REDUCED QUALITY OF LIFE (QOL). VARIOUS PHYSICAL AND MENTAL PRACTICES HAVE BEEN SHOWN TO RELIEVE STRESS AND IMPROVE QOL. YOGA IS A PHYSICAL AND MENTAL PRACTICE THAT MAY BE A VIABLE APPROACH FOR IMPROVING QOL IN PEOPLE WITH CHRONIC DISEASE. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EXAMINE AND SUMMARIZE THE EVIDENCE FOR THE EFFECTIVENESS OF YOGA ON QOL IN PATIENTS WITH CHRONIC DISEASE. DESIGN: THE STUDY DESIGN WAS A A SYSTEMATIC REVIEW WITH QUALITATIVE SYNTHESIS. METHODS: WE INCLUDED RANDOMIZED CONTROLLED TRIALS THAT EVALUATED THE EFFECT OF YOGA ON QOL OR HEALTH-RELATED QOL (HRQOL) FOR INDIVIDUALS WITH CHRONIC DISEASE. WE INCLUDED ONLY STUDIES THAT USED AT LEAST 1 PREVIOUSLY VALIDATED MEASURE OF QOL OR HRQOL AND SPECIFIED A MINIMUM DURATION OF FOLLOW-UP OF AT LEAST 1 WK. INTERVENTIONS: WE INCLUDED BOTH MOVEMENT-BASED AND BREATH-BASED YOGA PRACTICES. STUDIES THAT INCLUDED YOGA AS PART OF A LARGER INTERVENTION PROGRAM (EG, MINDFULNESS-BASED STRESS REDUCTION TRAINING) OR STUDIES THAT DID NOT PROVIDE FINDINGS SPECIFIC TO YOGA WERE EXCLUDED. PRIMARY OUTCOME MEASURES: THE PRIMARY OUTCOME ANALYZED WAS IMPROVEMENT IN QOL AS MEASURED BY A VALIDATED QOL OR HRQOL SCALE. RESULTS: AMONG THE 1488 STUDIES THAT WERE IDENTIFIED ON INITIAL SEARCH, 7 ARTICLES MET ALL INCLUSION CRITERIA. FIVE STUDIES REPORTED A STATISTICALLY SIGNIFICANT ADVANTAGE OVER USUAL CARE ALONE FOR IMPROVEMENT OF QOL IN PATIENTS WITH CHRONIC DISEASE, BUT THE CLINICAL SIGNIFICANCE OF THE DIFFERENCES WAS CLEAR IN ONLY 1 TRIAL. WE FOUND CONSIDERABLE HETEROGENEITY AMONG THE INCLUDED STUDIES AND STUDY QUALITY WAS GENERALLY LOW. CONCLUSIONS: MORE HIGH-QUALITY RESEARCH IS NEEDED TO DETERMINE THE VALUE OF YOGA AS AN ADJUNCTIVE APPROACH TO IMPROVING QOL IN PATIENTS WITH CHRONIC DISEASE. 2019 16 2830 53 YOGA VS STRETCHING IN VETERANS WITH CHRONIC LOWER BACK PAIN AND THE ROLE OF MINDFULNESS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FEASIBILITY OF RECRUITING, RANDOMIZING, ENROLLING, AND COLLECTING OUTCOME DATA ON VETERAN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP) WHO UNDERGO AN 8-WEEK, ACTIVE EXERCISE CLASS WITH MINDFULNESS (YOGA CLASS) AND WITHOUT (STRETCHING CLASS). METHODS: UNITED STATES VETERANS WITH CLBP BASED ON INCLUSION/EXCLUSION CRITERIA WERE RANDOMIZED TO 1 OF 2 GROUPS. THE STUDY DESIGN WAS A PILOT RANDOMIZED CONTROLLED TRIAL. TWENTY CLBP PATIENTS ATTENDED A YOGA CLASS OR STRETCHING CLASS ONCE PER WEEK FOR 8 WEEKS AT THE VETERANS AFFAIRS ROCHESTER OUTPATIENT CENTER, ROCHESTER, NEW YORK. THE FOLLOWING MEASUREMENTS WERE OBTAINED: RECRUITMENT OR ENROLLMENT DATA, COMPLIANCE DATA TO INCLUDE CLASS ATTENDANCE AND HOME EXERCISE, AND COMPLIANCE DATA REGARDING ABILITY TO COLLECT OUTCOME MEASURES AT BASELINE AND AT COMPLETION. OUTCOME MEASURES INCLUDED PAIN (PEG), QUALITY OF LIFE (PROMIS GLOBAL HEALTH SURVEY), SELF-EFFICACY (2-ITEM QUESTIONNAIRE), FEAR AVOIDANCE BELIEF, CATASTROPHIZING, AND SOCIAL ENGAGEMENT IN ADDITION TO QUALITATIVE CLINICIAN OPEN-ENDED QUESTIONS POSTINTERVENTION. RESULTS: FORTY-FIVE VETERANS WERE QUERIED REGARDING INTEREST IN PARTICIPATION. OF THESE, 34 (76%) MET THE STUDY'S CRITERIA. TWENTY (44%) AGREED TO PARTICIPATE AND WERE CONSENTED, RANDOMIZED, AND ENROLLED IN THE STUDY. INITIAL AND FINAL OUTCOME MEASURES WERE OBTAINED FOR EACH PARTICIPANT (100%). FORTY PERCENT ATTENDED MORE THAN 80% OF THE SESSIONS FOR BOTH YOGA AND STRETCHING GROUPS. CONCLUSION: THIS PILOT STUDY DEMONSTRATED FEASIBILITY OF RECRUITING, ENROLLING, AND COLLECTING OUTCOME DATA ON CLBP VETERAN PATIENTS PARTICIPATING IN YOGA AND STRETCHING CLASS. THE DATA FROM THIS PILOT WILL INFORM THE DEVELOPMENT OF A RANDOMIZED, COMPARATIVE EFFECTIVENESS STUDY OF YOGA WITH AND WITHOUT MINDFULNESS IN THE MANAGEMENT OF CLBP. 2020 17 70 50 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 18 2117 59 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 19 112 49 A PILOT STUDY OF A MINDFULNESS INFORMED YOGA INTERVENTION IN YOUNG PEOPLE WITH PSYCHOSIS. AIM: TO DETERMINE THE ACCEPTABILITY AND SAFETY OF A MINDFULNESS INFORMED YOGA INTERVENTION AS ADJUNCT TO USUAL CARE FOR YOUNG PEOPLE WITH EARLY PSYCHOSIS. METHODS: PEOPLE AGED 16-25 YEARS ATTENDING A COMMUNITY-BASED SPECIALIST EARLY PSYCHOSIS CLINIC WERE INVITED TO PARTICIPATE IN A 12-WEEK YOGA INTERVENTION. THE INTERVENTION CONSISTED OF 1-H WEEKLY CLASSES OF MINDFULNESS INFORMED YOGA. ACCEPTABILITY WAS MEASURED BY UPTAKE, ATTENDANCE AND PARTICIPANTS' SATISFACTION. SAFETY WAS MEASURED BY INCIDENCE OF PHYSICAL INJURY, PARTICIPANTS' LEVEL OF COMFORT, DISTRESS AND ANXIETY DURING THE SESSIONS, AND THE FOLLOWING MENTAL HEALTH OUTCOMES: POSITIVE AND NEGATIVE PSYCHOTIC, DEPRESSION, ANXIETY AND STRESS SYMPTOMS, SLEEP QUALITY AND FUNCTIONING. RESULTS: OF THOSE WHO CONSENTED TO THE STUDY, 80% (12) PARTICIPATED AND ON AVERAGE ATTENDED 4.4 YOGA CLASSES. THERE WERE NO PHYSICAL INJURIES AND PARTICIPANTS REPORTED MINIMAL DISTRESS AND ANXIETY. POST-INTERVENTION, THERE WAS A SIGNIFICANT REDUCTION IN ANXIETY SYMPTOMS AND AN IMPROVEMENT IN FUNCTION. CONCLUSIONS: MINDFULNESS-BASED YOGA INTERVENTIONS ARE BOTH ACCEPTABLE AND SAFE AS AN INTERVENTION FOR YOUTH WITH EARLY PSYCHOSIS. THOUGH NUMBERS WERE SMALL, THE STUDY SHOWS PROMISE FOR YOGA AS A POTENTIALLY USEFUL INTERVENTION. IMPORTANTLY, THERE WAS NO DETERIORATION IN MENTAL HEALTH OUTCOMES. A LARGER TRIAL EVALUATING CLINICAL EFFECTIVENESS IS NOW TIMELY. 2022 20 1180 59 EVALUATION OF THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. STUDY DESIGN: THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA FOR CHRONIC LOW BACK PAIN (CLBP) WERE ASSESSED WITH INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSIS. NINETY SUBJECTS WERE RANDOMIZED TO A YOGA (N = 43) OR CONTROL GROUP (N = 47) RECEIVING STANDARD MEDICAL CARE. PARTICIPANTS WERE FOLLOWED 6 MONTHS AFTER COMPLETION OF THE INTERVENTION. OBJECTIVE: THIS STUDY AIMED TO EVALUATE IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. YOGA SUBJECTS WERE HYPOTHESIZED TO REPORT GREATER REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, DEPRESSION, AND PAIN MEDICATION USAGE THAN CONTROLS. SUMMARY OF BACKGROUND DATA: CLBP IS A MUSCULOSKELETAL DISORDER WITH PUBLIC HEALTH AND ECONOMIC IMPACT. PILOT STUDIES OF YOGA AND BACK PAIN HAVE REPORTED SIGNIFICANT CHANGES IN CLINICALLY IMPORTANT OUTCOMES. METHODS: SUBJECTS WERE RECRUITED THROUGH SELF-REFERRAL AND HEALTH PROFESSIONAL REFERRALS ACCORDING TO EXPLICIT INCLUSION/EXCLUSION CRITERIA. YOGA SUBJECTS PARTICIPATED IN 24 WEEKS OF BIWEEKLY YOGA CLASSES DESIGNED FOR CLBP. OUTCOMES WERE ASSESSED AT 12 (MIDWAY), 24 (IMMEDIATELY AFTER), AND 48 WEEKS (6-MONTH FOLLOW-UP) AFTER THE START OF THE INTERVENTION USING THE OSWESTRY DISABILITY QUESTIONNAIRE, A VISUAL ANALOG SCALE, THE BECK DEPRESSION INVENTORY, AND A PAIN MEDICATION-USAGE QUESTIONNAIRE. RESULTS: USING INTENTION-TO-TREAT ANALYSIS WITH REPEATED MEASURES ANOVA (GROUP X TIME), SIGNIFICANTLY GREATER REDUCTIONS IN FUNCTIONAL DISABILITY AND PAIN INTENSITY WERE OBSERVED IN THE YOGA GROUP WHEN COMPARED TO THE CONTROL GROUP AT 24 WEEKS. A SIGNIFICANTLY GREATER PROPORTION OF YOGA SUBJECTS ALSO REPORTED CLINICAL IMPROVEMENTS AT BOTH 12 AND 24 WEEKS. IN ADDITION, DEPRESSION WAS SIGNIFICANTLY LOWER IN YOGA SUBJECTS. FURTHERMORE, WHILE A REDUCTION IN PAIN MEDICATION OCCURRED, THIS WAS COMPARABLE IN BOTH GROUPS. WHEN RESULTS WERE ANALYZED USING PER-PROTOCOL ANALYSIS, IMPROVEMENTS WERE OBSERVED FOR ALL OUTCOMES IN THE YOGA GROUP, INCLUDING AGREATER TREND FOR REDUCED PAIN MEDICATION USAGE. ALTHOUGH SLIGHTLY LESS THAN AT 24 WEEKS, THE YOGA GROUP HAD STATISTICALLY SIGNIFICANT REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION COMPARED TO STANDARD MEDICAL CARE 6-MONTHS POSTINTERVENTION. CONCLUSION: YOGA IMPROVES FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION IN ADULTS WITH CLBP. THERE WAS ALSO A CLINICALLY IMPORTANT TREND FOR THE YOGA GROUP TO REDUCE THEIR PAIN MEDICATION USAGE COMPARED TO THE CONTROL GROUP. 2009