1 168 133 A RANDOMIZED CONTROLLED DOSING STUDY OF IYENGAR YOGA AND COHERENT BREATHING FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER: IMPACT ON SUICIDAL IDEATION AND SAFETY FINDINGS. BACKGROUND: YOGA INTERVENTIONS OFFER PROMISE FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD), YET THEIR SAFETY AND POTENTIAL IMPACT ON SUICIDAL IDEATION (SI) HAVE NOT BEEN WELL DOCUMENTED. THIS STUDY EVALUATED THE SAFETY OF A RANDOMIZED CONTROLLED DOSE-FINDING TRIAL OF IYENGAR YOGA PLUS COHERENT BREATHING FOR INDIVIDUALS WITH MDD, AS WELL AS THE POTENTIAL EFFECTS OF THE INTERVENTION ON SI WITHOUT INTENT. METHODS: PARTICIPANTS WITH BECK DEPRESSION INVENTORY-II (BDI-II) SCORES >/=14 AND A DIAGNOSIS OF MDD (USING DSM-IV CRITERIA) WERE RANDOMIZED TO EITHER A LOW DOSE GROUP (LDG) OR HIGH DOSE GROUP (HDG) AND RECEIVED A 12-WEEK MANUALIZED INTERVENTION. THE LDG INCLUDED TWO 90-MIN YOGA CLASSES PLUS THREE 30-MIN HOMEWORK SESSIONS WEEKLY. THE HDG OFFERED THREE 90-MIN CLASSES PLUS FOUR 30-MIN HOMEWORK SESSIONS WEEKLY. RESULTS: THIRTY-TWO INDIVIDUALS WITH MDD WERE RANDOMIZED, OF WHICH 30 COMPLETED THE PROTOCOL. AT SCREENING, SI WITHOUT INTENT WAS ENDORSED ON THE BDI-II BY 9 PARTICIPANTS; AFTER COMPLETING THE INTERVENTION, 8 OUT OF 9 REPORTED RESOLUTION OF SI. THERE WERE 17 ADVERSE EVENTS POSSIBLY-RELATED AND 15 DEFINITELY-RELATED TO THE INTERVENTION. THE MOST COMMON PROTOCOL-RELATED ADVERSE EVENT WAS MUSCULOSKELETAL PAIN, WHICH RESOLVED OVER THE COURSE OF THE STUDY. CONCLUSIONS: THE IYENGAR YOGA PLUS COHERENT BREATHING INTERVENTION WAS ASSOCIATED WITH THE RESOLUTION OF SI IN 8 OUT OF 9 PARTICIPANTS, WITH MILD SIDE EFFECTS THAT WERE PRIMARILY MUSCULOSKELETAL IN NATURE. THIS PRELIMINARY EVIDENCE SUGGESTS THAT THIS INTERVENTION MAY REDUCE SI WITHOUT INTENT AND BE SAFE FOR USE IN THOSE WITH MDD. 2018 2 258 44 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 3 2318 45 TREATING MAJOR DEPRESSION WITH YOGA: A PROSPECTIVE, RANDOMIZED, CONTROLLED PILOT TRIAL. BACKGROUND: CONVENTIONAL PHARMACOTHERAPIES AND PSYCHOTHERAPIES FOR MAJOR DEPRESSION ARE ASSOCIATED WITH LIMITED ADHERENCE TO CARE AND RELATIVELY LOW REMISSION RATES. YOGA MAY OFFER AN ALTERNATIVE TREATMENT OPTION, BUT RIGOROUS STUDIES ARE FEW. THIS RANDOMIZED CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS EXAMINED AN 8-WEEK HATHA YOGA INTERVENTION AS MONO-THERAPY FOR MILD-TO-MODERATE MAJOR DEPRESSION. METHODS: INVESTIGATORS RECRUITED 38 ADULTS IN SAN FRANCISCO MEETING CRITERIA FOR MAJOR DEPRESSION OF MILD-TO-MODERATE SEVERITY, PER STRUCTURED PSYCHIATRIC INTERVIEW AND SCORES OF 14-28 ON BECK DEPRESSION INVENTORY-II (BDI). AT SCREENING, INDIVIDUALS ENGAGED IN PSYCHOTHERAPY, ANTIDEPRESSANT PHARMACOTHERAPY, HERBAL OR NUTRACEUTICAL MOOD THERAPIES, OR MIND-BODY PRACTICES WERE EXCLUDED. PARTICIPANTS WERE 68% FEMALE, WITH MEAN AGE 43.4 YEARS (SD = 14.8, RANGE = 22-72), AND MEAN BDI SCORE 22.4 (SD = 4.5). TWENTY PARTICIPANTS WERE RANDOMIZED TO 90-MINUTE HATHA YOGA PRACTICE GROUPS TWICE WEEKLY FOR 8 WEEKS. EIGHTEEN PARTICIPANTS WERE RANDOMIZED TO 90-MINUTE ATTENTION CONTROL EDUCATION GROUPS TWICE WEEKLY FOR 8 WEEKS. CERTIFIED YOGA INSTRUCTORS DELIVERED BOTH INTERVENTIONS AT A UNIVERSITY CLINIC. PRIMARY OUTCOME WAS DEPRESSION SEVERITY, MEASURED BY BDI SCORES EVERY 2 WEEKS FROM BASELINE TO 8 WEEKS. SECONDARY OUTCOMES WERE SELF-EFFICACY AND SELF-ESTEEM, MEASURED BY SCORES ON THE GENERAL SELF-EFFICACY SCALE (GSES) AND ROSENBERG SELF-ESTEEM SCALE (RSES) AT BASELINE AND AT 8 WEEKS. RESULTS: IN INTENT-TO-TREAT ANALYSIS, YOGA PARTICIPANTS EXHIBITED SIGNIFICANTLY GREATER 8-WEEK DECLINE IN BDI SCORES THAN CONTROLS (P-VALUE = 0.034). IN SUB-ANALYSES OF PARTICIPANTS COMPLETING FINAL 8-WEEK MEASURES, YOGA PARTICIPANTS WERE MORE LIKELY TO ACHIEVE REMISSION, DEFINED PER FINAL BDI SCORE /=14, AND WERE EITHER ON NO ANTIDEPRESSANT MEDICATIONS OR ON A STABLE DOSE OF ANTIDEPRESSANTS FOR >/=3 MONTHS. THE INTERVENTION INCLUDED 90-MIN CLASSES PLUS HOMEWORK. OUTCOME MEASURES WERE BDI-II SCORES AND INTERVENTION COMPLIANCE. RESULTS: FIFTEEN HDG (MAGE = 38.4 +/- 15.1 YEARS) AND 15 LDG (MAGE = 34.7 +/- 10.4 YEARS) SUBJECTS COMPLETED THE INTERVENTION. BDI-II SCORES AT SCREENING AND COMPLIANCE DID NOT DIFFER BETWEEN GROUPS (P = 0.26). BDI-II SCORES DECLINED SIGNIFICANTLY FROM SCREENING (24.6 +/- 1.7) TO WEEK 12 (6.0 +/- 3.8) FOR THE HDG (-18.6 +/- 6.6; P < 0.001), AND FROM SCREENING (27.7 +/- 2.1) TO WEEK 12 (10.1 +/- 7.9) IN THE LDG (-17.7 +/- 9.3; P < 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS, BASED ON RESPONSE (I.E., >50% DECREASE IN BDI-II SCORES; P = 0.65) FOR THE HDG (13/15 SUBJECTS) AND LDG (11/15 SUBJECTS) OR REMISSION (I.E., NUMBER OF SUBJECTS WITH BDI-II SCORES <14; P = 1.00) FOR THE HDG (14/15 SUBJECTS) AND LDG (13/15 SUBJECTS) AFTER THE 12-WEEK INTERVENTION, ALTHOUGH A GREATER NUMBER OF SUBJECTS IN THE HDG HAD 12-WEEK BDI-II SCORES /= 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 11 1746 43 PILOT EVALUATION OF AN IYENGAR YOGA PROGRAM FOR BREAST CANCER SURVIVORS. BACKGROUND: WITH CONTINUAL IMPROVEMENTS IN SCREENING UPTAKE AND ADJUVANT CANCER TREATMENTS, THE NUMBER OF CANADIAN WOMEN SURVIVING BREAST CANCER CONTINUES TO GROW. PRELIMINARY FINDINGS SUGGEST YOGA CAN IMPROVE QUALITY OF LIFE (QOL) IN BREAST CANCER SURVIVORS, BUT FEW STUDIES HAVE FOCUSED ON IYENGAR YOGA (IY). OBJECTIVE: THE PURPOSE OF THIS PILOT STUDY WAS TO EVALUATE THE IMPACT OF IY ON QOL AND PSYCHOSOCIAL FUNCTIONING IN A SELECT SAMPLE OF BREAST CANCER SURVIVORS. METHODS: BREAST CANCER SURVIVORS (N = 24) PARTICIPATING IN IY CLASSES COMPLETED A QUESTIONNAIRE MEASURING GENERIC AND DISEASE-SPECIFIC QOL AND PSYCHOSOCIAL FUNCTIONING, BEFORE AND AFTER THE 12-WEEK CLASSES. RESULTS: POSTPROGRAM QUESTIONNAIRES WERE COMPLETED BY 17 PARTICIPANTS (71%) WHO ATTENDED AN AVERAGE OF 78.9% OF THE IY SESSIONS. SEVERAL INDICATORS OF GENERIC QOL IMPROVED SIGNIFICANTLY, INCLUDING MENTAL HEALTH (MEAN CHANGE, +4.2; P = .045), VITALITY (MEAN CHANGE, +4.9; P = .033), ROLE-EMOTIONAL (MEAN CHANGE, +6.4; P = .010), AND BODILY PAIN (MEAN CHANGE, +4.4; P = .024). OTHER IMPROVEMENTS IN QOL AND PSYCHOSOCIAL FUNCTIONING WERE MEANINGFUL BUT WERE NOT STATISTICALLY SIGNIFICANT. FINDINGS WERE FURTHER SUBSTANTIATED BY PARTICIPANT'S EVALUATION OF THE PROGRAM'S BENEFITS AND MOTIVATIONAL VALUE. CONCLUSION: IN THIS PILOT STUDY OF BREAST CANCER SURVIVORS PARTICIPATING IN IY, WE FOUND IMPROVEMENTS IN QOL AND PSYCHOSOCIAL FUNCTIONING. MOREOVER, POSITIVE PROGRAM EVALUATION AND MOTIVATIONAL PROFILE PROVIDE SUPPORT FOR THE ACCEPTABILITY OF IY WITH BREAST CANCER SURVIVORS. RANDOMIZED CONTROLLED TRIALS COMPARING IY TO USUAL CARE AND OTHER FORMS OF YOGA IN BREAST CANCER SURVIVORS ARE WARRANTED. IMPLICATIONS FOR PRACTICE: NURSES MAY CONSIDER IY AS A POSSIBLE INTERVENTION STRATEGY TO HELP BREAST CANCER SURVIVORS IMPROVE THEIR QOL AND PSYCHOSOCIAL FUNCTIONING. 2010 12 2811 41 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 13 1902 39 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 14 70 40 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 15 1107 38 EFFECTS OF YOGA, STRENGTH TRAINING AND ADVICE ON BACK PAIN: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: AMONG THE WORKING POPULATION, NON-SPECIFIC LOW-BACK PAIN AND NECK PAIN ARE ONE OF THE MOST COMMON REASONS FOR SICKNESS ABSENTEEISM. THE AIM WAS TO EVALUATE THE EFFECTS OF AN EARLY INTERVENTION OF YOGA - COMPARED WITH STRENGTH TRAINING OR EVIDENCE-BASED ADVICE - ON SICKNESS ABSENTEEISM, SICKNESS PRESENTEEISM, BACK AND NECK PAIN AND DISABILITY AMONG A WORKING POPULATION. METHODS: A RANDOMIZED CONTROLLED TRIAL WAS CONDUCTED ON 159 PARTICIPANTS WITH PREDOMINANTLY (90%) CHRONIC BACK AND NECK PAIN. AFTER SCREENING, THE PARTICIPANTS WERE RANDOMIZED TO KUNDALINI YOGA, STRENGTH TRAINING OR EVIDENCE-BASED ADVICE. PRIMARY OUTCOME WAS SICKNESS ABSENTEEISM. SECONDARY OUTCOMES WERE SICKNESS PRESENTEEISM, BACK AND NECK PAIN AND DISABILITY. SELF-REPORTED QUESTIONNAIRES AND SMS TEXT MESSAGES WERE COMPLETED AT BASELINE, 6 WEEKS, 6 AND 12 MONTHS. RESULTS: THE RESULTS DID NOT INDICATE THAT KUNDALINI YOGA AND STRENGTH TRAINING HAD ANY STATISTICALLY SIGNIFICANT EFFECTS ON THE PRIMARY OUTCOME COMPARED WITH EVIDENCE-BASED ADVICE. AN INTERACTION EFFECT WAS FOUND BETWEEN ADHERENCE TO RECOMMENDATIONS AND SICKNESS ABSENTEEISM, INDICATING LARGER SIGNIFICANT EFFECTS AMONG THE ADHERERS TO KUNDALINI YOGA VERSUS EVIDENCE-BASED ADVICE: RR = 0.47 (CI 0.30; 0.74, P = 0.001), STRENGTH TRAINING VERSUS EVIDENCE-BASED ADVICE: RR = 0.60 (CI 0.38; 0.96, P = 0.032). SOME SIGNIFICANT DIFFERENCES WERE ALSO FOUND FOR THE SECONDARY OUTCOMES TO THE ADVANTAGE OF KUNDALINI YOGA AND STRENGTH TRAINING. CONCLUSIONS: GUIDED EXERCISE IN THE FORMS OF KUNDALINI YOGA OR STRENGTH TRAINING DOES NOT REDUCE SICKNESS ABSENTEEISM MORE THAN EVIDENCE-BASED ADVICE ALONE. HOWEVER, SECONDARY ANALYSES REVEAL THAT AMONG THOSE WHO PURSUE KUNDALINI YOGA OR STRENGTH TRAINING AT LEAST TWO TIMES A WEEK, A SIGNIFICANTLY REDUCTION IN SICKNESS ABSENTEEISM WAS FOUND. METHODS TO INCREASE ADHERENCE TO TREATMENT RECOMMENDATIONS SHOULD BE FURTHER DEVELOPED AND APPLIED IN EXERCISE INTERVENTIONS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT01653782, DATE OF REGISTRATION: JUNE, 28, 2012, RETROSPECTIVELY REGISTERED. 2017 16 1617 38 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 17 2604 38 YOGA FOR PERSISTENT FATIGUE IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER-RELATED FATIGUE AFFLICTS UP TO 33% OF BREAST CANCER SURVIVORS, YET THERE ARE NO EMPIRICALLY VALIDATED TREATMENTS FOR THIS SYMPTOM. METHODS: THE AUTHORS CONDUCTED A 2-GROUP RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE FEASIBILITY AND EFFICACY OF AN IYENGAR YOGA INTERVENTION FOR BREAST CANCER SURVIVORS WITH PERSISTENT POST-TREATMENT FATIGUE. PARTICIPANTS WERE BREAST CANCER SURVIVORS WHO HAD COMPLETED CANCER TREATMENTS (OTHER THAN ENDOCRINE THERAPY) AT LEAST 6 MONTHS BEFORE ENROLLMENT, REPORTED SIGNIFICANT CANCER-RELATED FATIGUE, AND HAD NO OTHER MEDICAL CONDITIONS THAT WOULD ACCOUNT FOR FATIGUE SYMPTOMS OR INTERFERE WITH YOGA PRACTICE. BLOCK RANDOMIZATION WAS USED TO ASSIGN PARTICIPANTS TO A 12-WEEK, IYENGAR-BASED YOGA INTERVENTION OR TO 12 WEEKS OF HEALTH EDUCATION (CONTROL). THE PRIMARY OUTCOME WAS CHANGE IN FATIGUE MEASURED AT BASELINE, IMMEDIATELY POST-TREATMENT, AND 3 MONTHS AFTER TREATMENT COMPLETION. ADDITIONAL OUTCOMES INCLUDED CHANGES IN VIGOR, DEPRESSIVE SYMPTOMS, SLEEP, PERCEIVED STRESS, AND PHYSICAL PERFORMANCE. INTENT-TO-TREAT ANALYSES WERE CONDUCTED WITH ALL RANDOMIZED PARTICIPANTS USING LINEAR MIXED MODELS. RESULTS: THIRTY-ONE WOMEN WERE RANDOMLY ASSIGNED TO YOGA (N = 16) OR HEALTH EDUCATION (N = 15). FATIGUE SEVERITY DECLINED SIGNIFICANTLY FROM BASELINE TO POST-TREATMENT AND OVER A 3-MONTH FOLLOW-UP IN THE YOGA GROUP RELATIVE TO CONTROLS (P = .032). IN ADDITION, THE YOGA GROUP HAD SIGNIFICANT INCREASES IN VIGOR RELATIVE TO CONTROLS (P = .011). BOTH GROUPS HAD POSITIVE CHANGES IN DEPRESSIVE SYMPTOMS AND PERCEIVED STRESS (P < .05). NO SIGNIFICANT CHANGES IN SLEEP OR PHYSICAL PERFORMANCE WERE OBSERVED. CONCLUSIONS: A TARGETED YOGA INTERVENTION LED TO SIGNIFICANT IMPROVEMENTS IN FATIGUE AND VIGOR AMONG BREAST CANCER SURVIVORS WITH PERSISTENT FATIGUE SYMPTOMS. 2012 18 1787 41 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH. 2015 19 2467 48 YOGA AS A THERAPY FOR ADOLESCENTS AND YOUNG ADULTS WITH CYSTIC FIBROSIS: A PILOT STUDY. RATIONALE: YOGA HAS BEEN SHOWN TO IMPROVE OUTCOMES IN PATIENTS WITH ASTHMA BUT HAS NOT BEEN INVESTIGATED IN CYSTIC FIBROSIS (CF) PATIENTS. METHODS: THIS WAS A PROSPECTIVE PILOT STUDY TO EVALUATE THE SAFETY OF A STANDARDIZED YOGA PROGRAM AMONG CF PATIENTS AGED 12 TO 25 YEARS. PARTICIPANTS ENGAGED IN A 50-MINUTE YOGA SESSION TWICE WEEKLY FOR 8 WEEKS CONDUCTED BY A CERTIFIED YOGA INSTRUCTOR USING A STANDARDIZED PROGRAM DESIGNED TO BE SAFE FOR HEALTH-COMPROMISED INDIVIDUALS. YOGA SESSIONS WERE INDIVIDUAL TO AVOID TRANSMISSION OF INFECTIONS. PRIMARY OUTCOME WAS SAFETY AND TOLERABILITY. SECONDARY OUTCOME MEASURES INCLUDED RESPIRATORY SYMPTOMS, THE CYSTIC FIBROSIS QUALITY OF LIFE INSTRUMENT (CFQ-R), LUNG FUNCTION, EASE OF BREATHING SCORE (MEASURE OF EXERCISE TOLERANCE), AND WEIGHT. RESULTS: ELEVEN PARTICIPANTS WERE ENROLLED, AND 10 COMPLETED THE STUDY. ADHERENCE WAS VERY GOOD; THE MEAN (SD) NUMBER OF SESSIONS COMPLETED WAS 14.2 (1.3) OUT OF 16 SESSIONS. EIGHT PATIENTS REPORTED 25 ADVERSE EVENTS. THE MOST COMMON WAS COUGH, REPORTED IN 7. TWO EVENTS WERE POSSIBLY RELATED TO STUDY PROCEDURES: CALF PAIN AND HEADACHE. THERE WERE NO SIGNIFICANT CHANGES IN DYSPNEA OR PAIN SCALES. THE MEAN (SD) CFQ-R RESPIRATORY DOMAIN SCORE INCREASED FROM SCREENING TO END OF STUDY: 67.9 (11.4) TO 82.1 (9.9), P=.04. THERE WERE NO SIGNIFICANT CHANGES IN THE OTHER OUTCOME MEASURES. CONCLUSIONS: IN THIS PILOT STUDY, A STANDARDIZED 8-WEEK YOGA PROGRAM WAS SAFE AND WELL TOLERATED AMONG ADOLESCENT AND YOUNG ADULT CF PATIENTS WITH MILD TO MODERATE LUNG DISEASE. THIS STUDY MAY BE HELPFUL TO YOGA INSTRUCTORS WHO ARE INTERESTED IN WORKING WITH CF PATIENTS. LARGER CONTROLLED TRIALS ARE WARRANTED TO DETERMINE FURTHER BENEFITS. 2015 20 1650 37 MULTICENTER, RANDOMIZED CONTROLLED TRIAL OF YOGA FOR SLEEP QUALITY AMONG CANCER SURVIVORS. PURPOSE: THIRTY PERCENT TO 90% OF CANCER SURVIVORS REPORT IMPAIRED SLEEP QUALITY POST-TREATMENT, WHICH CAN BE SEVERE ENOUGH TO INCREASE MORBIDITY AND MORTALITY. LIFESTYLE INTERVENTIONS, SUCH AS EXERCISE, ARE RECOMMENDED IN CONJUNCTION WITH DRUGS AND COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF IMPAIRED SLEEP. PRELIMINARY EVIDENCE INDICATES THAT YOGA-A MIND-BODY PRACTICE AND FORM OF EXERCISE-MAY IMPROVE SLEEP AMONG CANCER SURVIVORS. THE PRIMARY AIM OF THIS RANDOMIZED, CONTROLLED CLINICAL TRIAL WAS TO DETERMINE THE EFFICACY OF A STANDARDIZED YOGA INTERVENTION COMPARED WITH STANDARD CARE FOR IMPROVING GLOBAL SLEEP QUALITY (PRIMARY OUTCOME) AMONG POST-TREATMENT CANCER SURVIVORS. PATIENTS AND METHODS: IN ALL, 410 SURVIVORS SUFFERING FROM MODERATE OR GREATER SLEEP DISRUPTION BETWEEN 2 AND 24 MONTHS AFTER SURGERY, CHEMOTHERAPY, AND/OR RADIATION THERAPY WERE RANDOMLY ASSIGNED TO STANDARD CARE OR STANDARD CARE PLUS THE 4-WEEK YOGA INTERVENTION. THE YOGA INTERVENTION USED THE YOGA FOR CANCER SURVIVORS (YOCAS) PROGRAM CONSISTING OF PRANAYAMA (BREATHING EXERCISES), 16 GENTLE HATHA AND RESTORATIVE YOGA ASANAS (POSTURES), AND MEDITATION. PARTICIPANTS ATTENDED TWO 75-MINUTE SESSIONS PER WEEK. SLEEP QUALITY WAS ASSESSED BY USING THE PITTSBURGH SLEEP QUALITY INDEX AND ACTIGRAPHY PRE- AND POSTINTERVENTION. RESULTS: IN ALL, 410 SURVIVORS WERE ACCRUED (96% FEMALE; MEAN AGE, 54 YEARS; 75% HAD BREAST CANCER). YOGA PARTICIPANTS DEMONSTRATED GREATER IMPROVEMENTS IN GLOBAL SLEEP QUALITY AND, SECONDARILY, SUBJECTIVE SLEEP QUALITY, DAYTIME DYSFUNCTION, WAKE AFTER SLEEP ONSET, SLEEP EFFICIENCY, AND MEDICATION USE AT POSTINTERVENTION (ALL P