1 1247 182 FEASIBILITY OF YOGA AS A COMPLEMENTARY THERAPY FOR PATIENTS WITH TYPE 2 DIABETES: THE HEALTHY ACTIVE AND IN CONTROL (HA1C) STUDY. OBJECTIVES: THIS STUDY:HEALTHY ACTIVE AND IN CONTROL (HA1C), EXAMINED THE FEASIBILITY AND ACCEPTABILITY OF YOGA AS A COMPLEMENTARY THERAPY FOR ADULTS WITH TYPE-2 DIABETES (T2DM). DESIGN: A 2-ARM RANDOMIZED CLINICAL TRIAL COMPARING IYENGAR YOGA WITH A SUPERVISED WALKING PROGRAM. SETTING: HOSPITAL BASED GYM-TYPE FACILITY AND CONFERENCE ROOMS. INTERVENTIONS: PARTICIPANTS WERE RANDOMIZED TO A 12-WEEK PROGRAM OF EITHER; (1) A TWICE WEEKLY IYENGAR YOGA, OR (2) A TWICE-WEEKLY PROGRAM OF STANDARD EXERCISE (SE). MAIN OUTCOME MEASURES: PRIMARY OUTCOMES ASSESSED FEASIBILITY AND ACCEPTABILITY, INCLUDING ENROLLMENT RATES, ATTENDANCE, STUDY COMPLETION, AND PARTICIPANT SATISFACTION. SECONDARY OUTCOMES INCLUDED HBA1C, PHYSICAL ACTIVITY, AND MEASURES OF DIABETES-RELATED EMOTIONAL DISTRESS, SELF-CARE AND QUALITY OF LIFE (QOL). ASSESSMENTS WERE CONDUCTED AT BASELINE, END OF TREATMENT, 6-MONTHS AND 9-MONTHS POST-ENROLLMENT. RESULTS: OF 175 ADULTS SCREENED FOR ELIGIBILITY, 48 (30 WOMEN, 18 MEN) WERE ELIGIBLE AND ENROLLED. THE MOST COMMON REASONS FOR INELIGIBILITY WERE ORTHOPEDIC RESTRICTIONS, HBA1C LEVELS <6.5 AND BMI > 42. SESSION ATTENDANCE WAS HIGH (82% OF SESSIONS ATTENDED), AS WAS FOLLOW-UP COMPLETION RATES (92%). PROGRAM SATISFACTION RATED ON A 5-POINT SCALE, WAS HIGH AMONG BOTH YOGA (M = 4.63, SD = 0.57) AND SE (M = 4.77, SD = 0.52) PARTICIPANTS. OVERALL 44 ADVERSE EVENTS (26 YOGA, 18 SE) WERE REPORTED. OF THESE, SIX WERE DEEMED "POSSIBLY RELATED" (E.G., NECK STRAIN, BACK PAIN), AND 1 "PROBABLY RELATED" (ANKLE PAIN AFTER TREADMILL) TO THE STUDY. YOGA PRODUCED SIGNIFICANT REDUCTIONS IN HBA1C. MEDIAN HBA1C AT 6 MONTHS WAS 1.25 UNITS LOWER FOR YOGA COMPARED TO SE (95% CI: -2.54 -0.04). GREATER IMPROVEMENTS IN DIABETES SELF-CARE, QUALITY OF LIFE, AND EMOTIONAL DISTRESS WERE SEEN AMONG YOGA PARTICIPANTS THAN AMONG SE PARTICIPANTS. INCREASES IN MINDFULNESS WERE SEEN IN YOGA BUT NOT IN SE. CONCLUSIONS: THE YOGA INTERVENTION WAS HIGHLY FEASIBLE AND ACCEPTABLE, AND PRODUCED IMPROVEMENTS IN BLOOD GLUCOSE AND PSYCHOSOCIAL MEASURES OF DIABETES MANAGEMENT. 2019 2 551 45 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS. 2018 3 501 61 COMMUNITY BASED YOGA CLASSES FOR TYPE 2 DIABETES: AN EXPLORATORY RANDOMISED CONTROLLED TRIAL. BACKGROUND: YOGA IS A POPULAR THERAPY FOR DIABETES BUT ITS EFFICACY IS CONTESTED. THE AIM OF THIS STUDY WAS TO EXPLORE THE FEASIBILITY OF RESEARCHING COMMUNITY BASED YOGA CLASSES IN TYPE 2 DIABETES WITH A VIEW TO INFORMING THE DESIGN OF A DEFINITIVE, MULTI-CENTRE TRIAL METHODS: THE STUDY DESIGN WAS AN EXPLORATORY RANDOMISED CONTROLLED TRIAL WITH IN-DEPTH PROCESS EVALUATION. THE SETTING WAS TWO MULTI-ETHNIC BOROUGHS IN LONDON, UK; ONE WITH AVERAGE AND ONE WITH LOW MEAN SOCIO-ECONOMIC DEPRIVATION SCORE. CLASSES WERE HELD AT A SPORTS CENTRE OR GP SURGERY. PARTICIPANTS WERE 59 PEOPLE WITH TYPE 2 DIABETES NOT TAKING INSULIN, RECRUITED FROM GENERAL PRACTICE LISTS OR OPPORTUNISTICALLY BY GENERAL PRACTICE STAFF. THE INTERVENTION GROUP WERE OFFERED 12 WEEKS OF A TWICE-WEEKLY 90-MINUTE YOGA CLASS; THE CONTROL GROUP WAS A WAITING LIST FOR THE YOGA CLASSES. BOTH GROUPS RECEIVED ADVICE AND LEAFLETS ON HEALTHY LIFESTYLE AND WERE ENCOURAGED TO EXERCISE. PRIMARY OUTCOME MEASURE WAS HBA1C. SECONDARY OUTCOME MEASURES INCLUDED ATTENDANCE, WEIGHT, WAIST CIRCUMFERENCE, LIPID LEVELS, BLOOD PRESSURE, UKPDS CARDIOVASCULAR RISK SCORE, DIABETES-RELATED QUALITY OF LIFE (ADDQOL), AND SELF-EFFICACY. PROCESS MEASURES WERE ATTENDANCE AT YOGA SESSIONS, SELF-REPORTED FREQUENCY OF PRACTICE BETWEEN TAUGHT SESSIONS, AND QUALITATIVE DATA (INTERVIEWS WITH PATIENTS AND THERAPISTS, ETHNOGRAPHIC OBSERVATION OF THE YOGA CLASSES, AND ANALYSIS OF DOCUMENTS INCLUDING MINUTES OF MEETINGS, CORRESPONDENCE, AND EXERCISE PLANS). RESULTS: DESPITE BROAD INCLUSION CRITERIA, AROUND TWO-THIRDS OF THE PATIENTS ON GP DIABETIC REGISTERS PROVED INELIGIBLE, AND 90% OF THE REMAINDER DECLINED TO PARTICIPATE. MEAN AGE OF PARTICIPANTS WAS 60 +/- 10 YEARS. ATTENDANCE AT YOGA CLASSES WAS AROUND 50%. NOBODY DID THE EXERCISES REGULARLY AT HOME. YOGA TEACHERS FELT THAT MOST PARTICIPANTS WERE UNSUITABLE FOR 'STANDARD' YOGA EXERCISES BECAUSE OF LIMITED FLEXIBILITY, LACK OF BASIC FITNESS, CO-MORBIDITY, AND LACK OF CONFIDENCE. THERE WAS A SMALL FALL IN HBA1C IN THE YOGA GROUP WHICH WAS NOT STATISTICALLY SIGNIFICANT AND WHICH WAS NOT SUSTAINED SIX MONTHS LATER, AND NO SIGNIFICANT CHANGE IN OTHER OUTCOME MEASURES. CONCLUSION: THE BENEFITS OF YOGA IN TYPE 2 DIABETES SUGGESTED IN SOME PREVIOUS STUDIES WERE NOT CONFIRMED. POSSIBLE EXPLANATIONS (APART FROM LACK OF EFFICACY) INCLUDE RECRUITMENT CHALLENGES; PRACTICAL AND MOTIVATIONAL BARRIERS TO CLASS ATTENDANCE; PHYSICAL AND MOTIVATIONAL BARRIERS TO ENGAGING IN THE EXERCISES; INADEQUATE INTENSITY AND/OR DURATION OF YOGA INTERVENTION; AND INSUFFICIENT PERSONALISATION OF EXERCISES TO INDIVIDUAL NEEDS. ALL THESE FACTORS SHOULD BE CONSIDERED WHEN DESIGNING FUTURE TRIALS. TRIAL REGISTRATION: NATIONAL RESEARCH REGISTER (1410) AND CURRENT CONTROLLED TRIALS (ISRCTN63637211). 2009 4 2737 37 YOGA POSITIVELY AFFECTED DEPRESSION AND BLOOD PRESSURE IN WOMEN WITH PREMENSTRUAL SYNDROME IN A RANDOMIZED CONTROLLED CLINICAL TRIAL. WOMEN WITH PREMENSTRUAL SYNDROME (PMS) OFTEN COMPLAIN ABOUT DEPRESSION WHEN THEIR MENSTRUAL CYCLE BEGINS. THIS STUDY INVESTIGATED THE EFFECTS OF YOGA ON WOMEN WITH PMS SUFFERING FROM DEPRESSION DURING MENSTRUAL CYCLE. METHODS: THIS RANDOMIZED CONTROLLED CLINICAL TRIAL WAS CONDUCTED FROM APRIL TO OCTOBER 2015 IN TABRIZ, IRAN. ALL SUBJECTS (20-45 YEARS OLD), WHO WERE FREQUENTLY REFERRED TO THE PRIVATE OBSTETRICS AND GYNECOLOGY CLINICS, WERE INITIALLY MONITORED FOR PMS AND DEPRESSION. SUBJECTS COMPLETED THE DEMOGRAPHIC AND BECK DEPRESSION INVENTORY-II (BDI-II) QUESTIONNAIRES BEFORE AND AFTER INTERVENTION. IN ADDITION, SUBJECTS WERE MONITORED FOR ELIGIBLE AND INELIGIBLE CRITERIA. IN THIS STUDY 62 SUBJECTS WERE RANDOMLY SELECTED FOR THE YOGA GROUP AND CONTROL GROUPS. SUBJECTS PRACTICED YOGA OVER TWO MONTHS IN THREE SESSIONS, THE DURATION OF EACH SESSION WAS 60MIN. RESULTS: THE GENERAL SCORE OF THE DEPRESSION AFTER YOGA INTERVENTION WAS STATISTICALLY SIGNIFICANT COMPARED TO THE CONTROL GROUP (P<0.036) AND YOGA GROUP BEFORE INTERVENTION (P<0.001). THE DIASTOLIC PRESSURE DECREASED SIGNIFICANTLY AFTER YOGA INTERVENTION (P<0.029). YOGA DECREASED THE STATE OF DEPRESSION AND DIASTOLIC PRESSURE OF THE SUBJECTS WITH PMS COMPLAINING FROM DEPRESSION. CONCLUSION: WE CONCLUDE THAT YOGA HAS STRONG EFFECTS ON DEPRESSION SYMPTOMS AND BLOOD PRESSURE, THEREFORE IT CAN BE USED AS A COMPLEMENTARY OR ALTERNATIVE REMEDY FOR PMS PATIENTS. 2019 5 162 56 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 6 1748 44 PILOT RANDOMIZED, CONTROLLED TRIAL OF A DYADIC YOGA PROGRAM FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS. BACKGROUND: WHILE THE USE OF BEHAVIORAL MEDICINE IN MANAGING GLIOMA PATIENTS' SYMPTOMS IS NOT WELL STUDIED, THE HIGH SYMPTOM BURDEN IN PATIENTS AND THEIR FAMILY CAREGIVERS IS WELL ESTABLISHED. WE CONDUCTED A PILOT RANDOMIZED, CONTROLLED TRIAL TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFICACY OF A DYADIC YOGA (DY) INTERVENTION AS A SUPPORTIVE CARE STRATEGY. METHODS: GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS WERE RANDOMIZED TO A 12-SESSION DY OR WAITLIST CONTROL (WLC) GROUP. PRIOR TO RADIOTHERAPY AND RANDOMIZATION, BOTH GROUPS COMPLETED MEASURES OF CANCER-RELATED SYMPTOMS (MD ANDERSON SYMPTOM INVENTORY-BRAIN TUMOR MODULE), DEPRESSIVE SYMPTOMS (CENTER FOR EPIDEMIOLOGICAL STUDIES-DEPRESSION MEASURE), FATIGUE (BRIEF FATIGUE INVENTORY), AND OVERALL QUALITY OF LIFE (QOL; MEDICAL OUTCOMES STUDY 36-ITEM SHORT-FORM SURVEY). DYADS WERE REASSESSED AT THE LAST DAY OF RADIOTHERAPY. RESULTS: TWENTY PATIENTS (MEAN AGE: 46 YEARS, 50% FEMALE, 80% WHO GRADE IV AND CAREGIVERS (MEAN AGE: 50 YEARS, 70% FEMALE, 50% SPOUSES) PARTICIPATED IN THE TRIAL. A PRIORI FEASIBILITY CRITERIA WERE MET REGARDING CONSENT (70%), ADHERENCE (88%), AND RETENTION (95%) RATES. CONTROLLING FOR RELEVANT COVARIATES, CHANGE SCORE ANALYSES REVEALED CLINICALLY SIGNIFICANT IMPROVEMENTS FOR PATIENTS IN THE DY COMPARED WITH THE WLC GROUP FOR OVERALL CANCER SYMPTOM SEVERITY (D = 0.96) AND SYMPTOM INTERFERENCE (D = 0.74), DEPRESSIVE SYMPTOMS (D = 0.71), AND MENTAL QOL (D = 0.69). CAREGIVERS IN THE DY GROUP REPORTED CLINICALLY SIGNIFICANT IMPROVEMENTS IN DEPRESSIVE SYMPTOMS (D = 1.12), FATIGUE (D = 0.89), AND MENTAL QOL (D = 0.49) RELATIVE TO THOSE IN THE WLC GROUP. CONCLUSION: A DY INTERVENTION APPEARS TO BE A FEASIBLE AND BENEFICIAL SYMPTOM AND QOL MANAGEMENT STRATEGY FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS. AN EFFICACY TRIAL WITH A MORE STRINGENT CONTROL GROUP IS WARRANTED. CLINICAL TRIAL NUMBER: NCT02481349. 2019 7 41 49 A BRIEF YOGA INTERVENTION IMPLEMENTED DURING CHEMOTHERAPY: A RANDOMIZED CONTROLLED PILOT STUDY. OBJECTIVES: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS (E.G., SLEEP DISTURBANCE) ARE CRITICAL TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS UNDERGOING CHEMOTHERAPY. YOGA MAY REDUCE THE BURDEN OF SUCH SYMPTOMS. THIS STUDY INVESTIGATED THE FEASIBILITY OF CONDUCTING A RANDOMIZED CONTROLLED STUDY OF A BRIEF YOGA INTERVENTION DURING CHEMOTHERAPY FOR COLORECTAL CANCER. DESIGN: WE RANDOMIZED ADULTS WITH COLORECTAL CANCER TO A BRIEF YOGA SKILLS TRAINING (YST) OR AN ATTENTION CONTROL (AC; EMPATHIC ATTENTION AND RECORDED EDUCATION). SETTING: THE INTERVENTIONS AND ASSESSMENTS WERE IMPLEMENTED INDIVIDUALLY IN THE CLINIC WHILE PATIENTS WERE IN THE CHAIR RECEIVING CHEMOTHERAPY. INTERVENTIONS: BOTH INTERVENTIONS CONSISTED OF THREE SESSIONS AND RECOMMENDED HOME PRACTICE. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS FEASIBILITY (ACCRUAL, RETENTION, ADHERENCE, DATA COLLECTION). SELF-REPORTED OUTCOMES (I.E., FATIGUE, SLEEP DISTURBANCE, QUALITY OF LIFE) AND INFLAMMATORY BIOMARKERS WERE ALSO DESCRIBED TO INFORM FUTURE STUDIES. RESULTS: OF 52 PATIENTS INITIALLY IDENTIFIED, 28 WERE APPROACHED, AND 15 ENROLLED (AGE MEAN = 57.5 YEARS; 80% WHITE; 60% MALE). REASONS FOR DECLINING PARTICIPATION WERE: NOT INTERESTED (N = 6), DID NOT PERCEIVE A NEED (N = 2), AND OTHER (N = 5). TWO PARTICIPANTS WERE LOST TO FOLLOW-UP IN EACH GROUP DUE TO TREATMENT CHANGES. THUS, 75% OF PARTICIPANTS WERE RETAINED IN THE YST AND 71% IN THE AC ARM. PARTICIPANTS RETAINED IN THE STUDY ADHERED TO 97% OF THE IN-PERSON INTERVENTION SESSIONS AND COMPLETED ALL QUESTIONNAIRES. CONCLUSIONS: THIS STUDY DEMONSTRATED THE FEASIBILITY OF CONDUCTING A LARGER RANDOMIZED CONTROLLED TRIAL TO ASSESS YST AMONG PATIENTS RECEIVING CHEMOTHERAPY FOR COLORECTAL CANCER. DATA COLLECTED AND CHALLENGES ENCOUNTERED WILL INFORM FUTURE RESEARCH. 2016 8 172 40 A RANDOMIZED CONTROLLED PILOT STUDY OF YOGA SKILLS TRAINING VERSUS AN ATTENTION CONTROL DELIVERED DURING CHEMOTHERAPY ADMINISTRATION. CONTEXT: IT IS IMPORTANT TO ADDRESS FATIGUE AND CO-OCCURRING SYMPTOMS DURING CHEMOTHERAPY TO PRESERVE QUALITY OF LIFE IN PATIENTS WITH GASTROINTESTINAL (GI) CANCER. OBJECTIVE: TO CONDUCT A RANDOMIZED CONTROLLED PILOT STUDY OF A YOGA SKILLS TRAINING (YST) INTERVENTION COMPARED TO AN ATTENTION CONTROL (AC) AMONG ADULTS DIAGNOSED WITH GI CANCER. METHODS: YST CONSISTED OF FOUR 30-MINUTE SESSIONS DELIVERED INDIVIDUALLY DURING CHEMOTHERAPY PLUS HOME PRACTICE. AC PROVIDED EMPATHIC ATTENTION PLUS HOME DIARIES. PATIENT-REPORTED (PROMIS T-SCORE) ASSESSMENTS OF FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND PSYCHOLOGICAL STRESS (PERCEIVED STRESS SCALE) WERE COLLECTED AT CHEMOTHERAPY VISITS: BASELINE, WEEK 8, WEEK 10 AND WEEK 14, AND ANALYZED USING A MIXED EFFECTS MODEL. INFLAMMATORY CYTOKINES WERE ASSESSED AT BASELINE AND WEEK 10. RESULTS: FORTY-FOUR OF 77 ADULTS APPROACHED AGREED TO PARTICIPATE (57%; YST N = 23; AC N = 21). PARTICIPANTS' MEAN AGE WAS 58 YEARS AND 48% WERE MEN. PARTICIPANTS RANDOMIZED TO YST REPORTED A LARGER DECLINE IN FATIGUE (-2.4 DIFFERENCE, D = 0.30) AND DEPRESSIVE SYMPTOMS (-2.5 DIFFERENCE, D = 0.30) THAN AC PARTICIPANTS FROM BASELINE TO WEEK 10 AND SLEEP DISTURBANCES AT WEEK 8 (-3.9 DIFFERENCE, D = 0.50). DIFFERENCES IN MAGNITUDE OF CHANGE IN SYMPTOMS WERE CONSISTENT WITH OR EXCEEDED A MINIMALLY IMPORTANT DIFFERENCE. PSYCHOLOGICAL STRESS DECREASED MORE IN THE AC AT WEEK 10 (D = 0.30). REDUCTIONS IN INFLAMMATORY CYTOKINES (IL-6, STNF R1) WERE LARGER IN THE YST GROUP THAN AC. CONCLUSION: YST SHOWED PROMISE FOR IMPROVING FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND INFLAMMATION. YST IS ALSO FEASIBLE AND REACHES PATIENTS UNDERREPRESENTED IN YOGA RESEARCH (I.E., GI CANCER, MEN), THUS WARRANTING FURTHER EXAMINATION. 2022 9 199 41 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349. 2019 10 518 41 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013 11 2452 68 YOGA AS A COMPLEMENTARY THERAPY FOR ADULTS WITH TYPE 2 DIABETES: DESIGN AND RATIONALE OF THE HEALTHY, ACTIVE, AND IN CONTROL (HA1C) STUDY. DIABETES IS THE SEVENTH LEADING CAUSE OF DEATH IN THE UNITED STATES. FOR MOST PATIENTS, MEDICATION ALONE IS NOT SUFFICIENT TO ACHIEVE GLYCEMIC CONTROL; ATTENTION MUST ALSO BE PAID TO MULTIPLE HEALTHY BEHAVIORS INCLUDING DIET, REGULAR PHYSICAL ACTIVITY, AND STRESS MANAGEMENT. YOGA, A MINDFULNESS PRACTICE WITH EMPHASIS ON RELAXATION, MEDITATION, AND DEEP BREATHING, MAY HAVE SPECIAL RELEVANCE TO PEOPLE WITH TYPE 2 DIABETES MELLITUS (T2DM). YOGA PRACTICE MAY POSITIVELY AFFECT STRESS AND OTHER SELF-CARE TASKS THAT WILL CONTRIBUTE TO IMPROVED GLYCEMIC CONTROL. THE HEALTHY, ACTIVE, AND IN CONTROL (HA1C) STUDY IS DESIGNED TO EXAMINE THE FEASIBILITY AND ACCEPTABILITY OF YOGA AMONG ADULT PATIENTS WITH T2DM. IN THIS PILOT RANDOMIZED CONTROLLED TRIAL, ADULTS WITH T2DM WERE RANDOMLY ASSIGNED TO EITHER A 12-WEEK IYENGAR YOGA INTERVENTION GIVEN TWICE WEEKLY, OR A TWICE-WEEKLY 12-WEEK PROGRAM OF TRADITIONAL EXERCISE (E.G., WALKING, STATIONARY CYCLING). ASSESSMENTS ARE CONDUCTED AT THE END OF TREATMENT (12 WEEKS) AND AT 3 AND 6 MONTHS POSTINTERVENTION. THE HA1C STUDY WILL ASSESS FEASIBILITY AND ACCEPTABILITY (E.G., ATTENDANCE/RETENTION RATES, SATISFACTION WITH PROGRAM), GLYCEMIC OUTCOMES (E.G., HBA1C, FASTING BLOOD GLUCOSE, POSTPRANDIAL BLOOD GLUCOSE), AND CHANGES IN PHYSIOLOGICAL (E.G., SALIVARY CORTISOL) AND BEHAVIORAL FACTORS (E.G., PHYSICAL ACTIVITY, DIET) RELEVANT TO THE MANAGEMENT OF T2DM. FOCUS GROUPS ARE CONDUCTED AT THE END OF THE INTERVENTION TO EXPLORE PARTICIPANTS' EXPERIENCE WITH THE PROGRAM AND THEIR PERCEPTION OF THE POTENTIAL UTILITY OF YOGA FOR DIABETES MANAGEMENT. 2018 12 258 47 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 13 1331 47 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 14 312 50 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 15 1240 57 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 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 2628 55 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 18 70 48 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 19 1080 32 EFFECTS OF YOGA ON QUALITY OF SLEEP OF WOMEN WITH PREMENSTRUAL SYNDROME. OBJECTIVE: WOMEN WITH PREMENSTRUAL SYNDROME (PMS) COMMONLY COMPLAIN OF SLEEP DISTURBANCES, SPECIFICALLY IN THE LUTEAL PHASE OF THE MENSTRUAL CYCLE. THEREFORE, THE EFFECTS OF YOGA ON QUALITY OF SLEEP OF WOMEN EXPERIENCING PMS WAS INVESTIGATED. MATERIAL AND METHODS: WOMEN (AGED 20-45 Y) MONITORED FOR PMS, WHO WERE REFERRED TO THE PRIVATE OBSTETRICS AND GYNECOLOGY CLINICS IN TABRIZ, IRAN, WERE REFERRED TO THE PRIVATE OBSTETRICS AND GYNECOLOGY CLINICS IN TABRIZ, IRAN. AFTERWARD, 62 WOMEN, WERE SELECTED AND DIVIDED INTO 2 GROUPS, RANDOMLY: 31 SUBJECTS IN YOGA THE YOGA GROUP AND 31 IN THE CONTROL GROUP. SUBJECTS IN YOGA PERFORMED FOR 10 WK IN 3 SESSIONS, WITH EACH SESSION LASTING 60 MIN. SUBJECTS IN THE CONTROL GROUP DID NOT PERFORM ANY YOGA. SUBJECTS COMPLETED A DEMOGRAPHIC QUESTIONNAIRE AND THE PITTSBURGH SLEEP QUALITY INDEX QUESTIONNAIRE BEFORE AND AFTER YOGA IN BOTH GROUPS. RESULTS: AFTER YOGA INTERVENTION, SUBJECTS SIGNIFICANTLY EXPRESSED IMPROVEMENT IN SLEEPING (P < .05). BASED ON THE MANN-WHITNEY U TEST, A SIGNIFICANT DIFFERENCE WAS OBSERVED IN THE SUBDOMAINS OF BOTH GROUPS ON QUALITY OF SLEEP (P < .01), SLEEP LATENCY (P < .01), AND SLEEP EFFICIENCY (P < .05). CONCLUSION: YOGA REDUCED THE DISTURBANCES OF SLEEP IN THE SUBJECTS WITH PMS, WHICH SUBSEQUENTLY IMPROVED THE EFFICIENCY OF THEIR SLEEP. THEREFORE, WE CONCLUDE THAT YOGA CAN BE PRESCRIBED FOR IMPROVING SLEEP DISTURBANCES IN WOMEN WITH PMS AND MEDICAL THERAPY WILL PROBABLY BE NEEDED IN SEVERE SITUATIONS. 2019 20 1865 47 RANDOMIZED PILOT TRIAL OF YOGA VERSUS STRENGTHENING EXERCISES IN BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE. PURPOSE: FATIGUE IS ONE OF THE MOST COMMON AND BOTHERSOME REFRACTORY SYMPTOMS EXPERIENCED BY CANCER SURVIVORS. MINDFUL EXERCISE INTERVENTIONS SUCH AS YOGA IMPROVE CANCER-RELATED FATIGUE; HOWEVER, STUDIES OF YOGA HAVE INCLUDED HETEROGENEOUS SURVIVORSHIP POPULATIONS, AND THE EFFECT OF YOGA ON FATIGUED SURVIVORS REMAINS UNCLEAR. METHODS: WE RANDOMLY ASSIGNED 34 EARLY-STAGE BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE (>/=4 ON A LIKERT SCALE FROM 1-10) WITHIN 1 YEAR FROM DIAGNOSIS TO A 12-WEEK INTERVENTION OF HOME-BASED YOGA VERSUS STRENGTHENING EXERCISES, BOTH PRESENTED ON A DVD. THE PRIMARY ENDPOINTS WERE FEASIBILITY AND CHANGES IN FATIGUE, AS MEASURED BY THE MULTIDIMENSIONAL FATIGUE SYMPTOM INVENTORY-SHORT FORM (MFSI-SF). SECONDARY ENDPOINT WAS QUALITY OF LIFE, ASSESSED BY THE FUNCTIONAL ASSESSMENT OF CANCER THERAPIES-BREAST (FACT-B). RESULTS: WE INVITED 401 WOMEN TO PARTICIPATE IN THE STUDY; 78 RESPONDED, AND WE ENROLLED 34. BOTH GROUPS HAD SIGNIFICANT WITHIN-GROUP IMPROVEMENT IN MULTIPLE DOMAINS OF THE FATIGUE AND QUALITY OF LIFE SCORES FROM BASELINE TO POST-INTERVENTION, AND THESE BENEFITS WERE MAINTAINED AT 3 MONTHS POST-INTERVENTION. HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS IN FATIGUE OR QUALITY OF LIFE AT ANY ASSESSMENT TIME. SIMILARLY, THERE WAS NO DIFFERENCE BETWEEN GROUPS IN ADHERENCE TO THE EXERCISE INTERVENTION. CONCLUSIONS: BOTH DVD-BASED YOGA AND STRENGTHENING EXERCISES DESIGNED FOR CANCER SURVIVORS MAY BE GOOD OPTIONS TO ADDRESS FATIGUE IN BREAST CANCER SURVIVORS. BOTH HAVE REASONABLE UPTAKE, ARE CONVENIENT AND REPRODUCIBLE, AND MAY BE HELPFUL IN DECREASING FATIGUE AND IMPROVING QUALITY OF LIFE IN THE FIRST YEAR POST-DIAGNOSIS IN BREAST CANCER PATIENTS WITH CANCER-RELATED FATIGUE. 2016