1 1632 198 MIYOGA: A RANDOMISED CONTROLLED TRIAL OF A MINDFULNESS MOVEMENT PROGRAMME BASED ON HATHA YOGA PRINCIPLES FOR CHILDREN WITH CEREBRAL PALSY: A STUDY PROTOCOL. INTRODUCTION: CEREBRAL PALSY (CP) IS THE MOST COMMON CHILDHOOD PHYSICAL DISABILITY, WITH LIFE-LONG IMPACTS FOR 1.77 IN 1000 CHILDREN. ALTHOUGH CP IS PRIMARILY A PHYSICAL DISABILITY, CHILDREN WITH CP HAVE AN INCREASED RISK OF EXPERIENCING COGNITIVE DIFFICULTIES, PARTICULARLY ATTENTION AND EXECUTIVE FUNCTION DEFICITS. IMPAIRMENT IN COGNITIVE ABILITIES CAN LEAD TO SUBSEQUENT IMPAIRMENT IN INDEPENDENT FUNCTIONING, EDUCATION, EMPLOYMENT AND INTERPERSONAL RELATIONSHIPS. THIS PAPER REPORTS THE PROTOCOL OF A RANDOMISED CONTROLLED TRIAL OF A NOVEL FAMILY-CENTRED LIFESTYLE INTERVENTION BASED ON MINDFULNESS AND HATHA YOGA PRINCIPLES (MIYOGA). MIYOGA AIMS TO ENHANCE CHILD AND PARENT OUTCOMES FOR CHILDREN WITH CP. METHODS AND ANALYSIS: THE AIM IS TO RECRUIT 36 CHILD-PARENT DYADS (CHILDREN AGED 6-16 YEARS; BILATERAL OR UNILATERAL CP; GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM I-III), WHO WILL BE RANDOMLY ASSIGNED TO TWO GROUPS: MIYOGA ANDWAITLISTT CONTROL. THE MIYOGA PROGRAMME WILL BE FACILITATED IN A GROUP FORMAT FOR 8 WEEKS. ASSESSMENTS WILL BE ADMINISTERED AT BASELINE, PRIOR TO MIYOGA, FOLLOWING COMPLETION OF MIYOGA, AND AT 6-MONTH FOLLOW-UP (RETENTION). THE PRIMARY OUTCOME WILL BE THE CHILD'S SUSTAINED ATTENTIONAL ABILITY AS MEASURED BY THE CONNER'S CONTINUOUS PERFORMANCE TEST II. OTHER OUTCOMES OF INTEREST FOR CHILDREN WITH CP CONSISTS OF ATTENTIONAL CONTROL, PHYSICAL FUNCTIONING, BEHAVIOURAL AND WELL-BEING. FOR PARENTS, THE OUTCOMES OF INTEREST ARE MINDFULNESS, PSYCHOLOGICAL FLEXIBILITY AND WELL-BEING. DATA WILL BE ANALYSED USING GENERAL LINEAR MODELS, SPECIFICALLY ANALYSIS OF COVARIANCE AND ANALYSIS OF VARIANCE. ETHICS AND DISSEMINATION: FULL ETHICAL APPROVAL FOR THIS STUDY HAS BEEN OBTAINED BY THE CHILDREN'S HEALTH QUEENSLAND HOSPITAL AND HEALTH SERVICE RESEARCH ETHICS COMMITTEE (HREC/12/QRCH/120) AND THE UNIVERSITY OF QUEENSLAND (2012000993). IF MIYOGA IS PROVEN EFFECTIVE, ITS DISSEMINATION WOULD ASSIST CHILDREN WITH CP AND COMPLEMENT THEIR ONGOING THERAPY BY IMPROVING THE ABILITY OF THE CHILD TO PAY ATTENTION AT SCHOOL AND IN THERAPY, AND ALLEVIATING ENVIRONMENTALSTRESSORSS FOR BOTH THE CHILD AND HIS/HER PARENTS. TRIAL REGISTRATION NUMBER: ACTRN12613000729729; PRE-RESULTS.HTTP://WWW.ANZCTR.ORG.AU/ACTRN12613000729729.ASPX DATE OF TRIAL REGISTRATION: PROSPECTIVELY REGISTERED ON 2 JULY 2013-PRESENT (ONGOING). FINDINGS TO DATE: RECRUITMENT IS COMPLETE. DATA ARE STILL BEING COLLECTED AT PRESENT. WE AIM TO COMPLETE DATA COLLECTION BY FEBRUARY 2017.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
2 1205  35 EXPERIENCES OF CHILDREN AND PARENTS IN MIYOGA, AN EMBODIED MINDFULNESS YOGA PROGRAM FOR CEREBRAL PALSY: A MIXED METHOD STUDY. BACKGROUND AND PURPOSE: A MINDFULNESS YOGA PROGRAM (MIYOGA) WAS DEVELOPED AND TRIALLED WITH CHILDREN WITH CEREBRAL PALSY AND THEIR PARENTS. THIS MIXED-METHOD STUDY EXPLORES THE EXPERIENCES OF CHILDREN AND PARENTS WHO PARTICIPATED IN MIYOGA, TO ASSESS ITS ACCEPTABILITY, FEASIBILITY AND IMPLEMENTATION. MATERIALS AND METHODS: OF THE FORTY-TWO CHILD-PARENT DYADS WHO PARTICIPATED IN THE MIYOGA RANDOMISED CONTROL TRIAL, 19 CHILDREN AND 22 PARENTS WERE INTERVIEWED INDIVIDUALLY IN A SEMI-STRUCTURED WAY ABOUT THEIR EXPERIENCES OF MIYOGA. PARTICIPANTS RATED THEIR MOOD ON A 5-POINT SCALE BEFORE AND AFTER EACH SESSION AND COMPLETED SHORT QUESTIONNAIRES AT THE END OF EACH SESSION. RESULTS: CHILDREN AND PARENTS REPORTED IMPROVED MOOD AFTER EACH MIYOGA SESSION. PARENTS REPORTED BEING MORE AWARE OF THEIR THOUGHTS AND FEELINGS AND POSSIBLY BECAME MORE AWARE OF THEIR DAY-TO-DAY MINDLESSNESS. CONCLUSION: MIYOGA SIGNIFICANTLY IMPROVED CHILDREN AND PARENTS' MOOD. PARENTS REPORTED GAINS IN AWARENESS AS WELL AS CHALLENGES OF ADHERING TO THE HOME PRACTICE.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
3  732  64 EFFECT OF MINDFULNESS YOGA PROGRAMME MIYOGA ON ATTENTION, BEHAVIOUR, AND PHYSICAL OUTCOMES IN CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL. AIM: TO INVESTIGATE THE EFFICACY OF AN EMBODIED MINDFULNESS-BASED MOVEMENT PROGRAMME (MIYOGA), TARGETING ATTENTION IN CHILDREN WITH CEREBRAL PALSY (CP). METHOD: TOTAL NUMBER OF PARTICIPANTS 42, WITH 24 BOYS (57.1%) AND 18 GIRLS (42.9%); MEAN AGE 9Y 1MO, SD 3Y; GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM LEVELS I=22, II=12, III=8) AND THEIR PARENTS WERE RANDOMIZED TO EITHER MIYOGA (N=21) OR WAITLIST COMPARISON (N=21) GROUPS. THE PRIMARY OUTCOME WAS ATTENTION POSTINTERVENTION MEASURED BY THE CONNERS' CONTINUOUS PERFORMANCE TEST, SECOND EDITION (CCPT). SECONDARY OUTCOMES INCLUDED PARENT AND CHILD MINDFULNESS, CHILD QUALITY OF LIFE, PARENTAL WELL-BEING, CHILD EXECUTIVE FUNCTION, CHILD BEHAVIOUR, CHILD PHYSICAL MEASURES, AND THE PARENT-CHILD RELATIONSHIP. RESULTS: CHILDREN IN THE MIYOGA GROUP DEMONSTRATED SIGNIFICANTLY BETTER ATTENTION POSTINTERVENTION THAN THE WAITLIST COMPARISON GROUP, WITH LOWER INATTENTION SCORES ON THE HIT REACTION TIME STANDARD ERROR (F1,33 =4.59, P=0.04, PARTIAL ETA-SQUARED [ETAP2]=0.13) VARIABLE AND FEWER PERSEVERATION ERRORS (F1,33 =4.60, P=0.04, ETAP2=0.13) ON THE CCPT. INTENTION-TO-TREAT ANALYSIS ALSO REVEALED THAT SUSTAINED ATTENTION IN THE MIYOGA GROUP WAS SIGNIFICANTLY BETTER THAN IN THE WAITLIST COMPARISON GROUP POSTINTERVENTION (F1,37 =5.97, P=0.02, ETAP2=0.14). PARENTS IN THE MIYOGA GROUP DEMONSTRATED SIGNIFICANTLY DECREASED MINDFULNESS (MINDFULNESS ATTENTION AWARENESS SCALE; F1,33 =10.130, P=0.003, ETAP2=0.246). INTERPRETATION: MIYOGA OFFERS A LIFESTYLE INTERVENTION THAT IMPROVES ATTENTION IN CHILDREN WITH CP. MIYOGA CAN BE CONSIDERED AS AN ADDITIONAL OPTION TO STANDARD REHABILITATION TO ENHANCE ATTENTION FOR CHILDREN WITH CP. WHAT THIS PAPER ADDS: MIYOGA, AN EMBODIED MINDFULNESS-BASED MOVEMENT PROGRAMME, CAN ENHANCE ATTENTION (MORE ATTENTIVE AND CONSISTENT PERFORMANCE) IN CHILDREN WITH CEREBRAL PALSY. MIYOGA HAD NO SIGNIFICANT EFFECT ON PHYSICAL FUNCTIONING.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
4 1976  71 SIX-MONTH FOLLOW-UP OF A MINDFULNESS YOGA PROGRAM, MIYOGA, ON ATTENTION, EXECUTIVE FUNCTION, BEHAVIOUR AND PHYSICAL OUTCOMES IN CEREBRAL PALSY. PURPOSE: A RANDOMISED CONTROLLED TRIAL (RCT) OF A MINDFULNESS-BASED YOGA PROGRAM, MIYOGA, FOR CEREBRAL PALSY (CP) DEMONSTRATED IMPROVED ATTENTION IN CHILDREN AND DECREASED MINDFULNESS IN PARENTS POST-INTERVENTION. THIS PAPER EVALUATES THE RETENTION OF TREATMENT EFFECTS AT 6-MONTHS FOLLOW-UP. METHODS: 42 CHILDREN WITH CP AND THEIR PARENTS PARTICIPATED IN A RCT WITH TWO GROUPS MIYOGA (N = 21) AND WAITLIST CONTROL GROUP (N = 21). WAITLIST CONTROL PARTICIPANTS WERE OFFERED MIYOGA FOLLOWING THE POST-INTERVENTION ASSESSMENT. 23 OUT OF 42 CHILD-PARENT DYADS FROM BOTH GROUPS COMPLETED FOLLOW-UP ASSESSMENT 6-MONTHS AFTER COMPLETING MIYOGA. THIS PAPER EVALUATES AND REPORTS DATA FROM BOTH GROUPS COLLAPSED (N = 23; MIYOGA N = 11; AND WAITLIST CONTROL N = 12; 47.8% MALE; MEAN AGE = 9:10 +/- 2.4 YEARS) TO ASSESS RETENTION FROM POST-MIYOGA TO FOLLOW-UP AND PRE-MIYOGA TO FOLLOW-UP. THE PRIMARY OUTCOME WAS ATTENTION, MEASURED BY CONNER'S CONTINUOUS PERFORMANCE TEST II (CCPT). SECONDARY OUTCOMES INCLUDED CHILD EXECUTIVE FUNCTION, PHYSICAL FUNCTION, BEHAVIOUR, QUALITY OF LIFE, CHILD AND PARENT MINDFULNESS, PERSONAL WELLBEING, PSYCHOLOGICAL WELLBEING AND PARENT-CHILD RELATIONSHIP. RESULTS: PAIRED T-TESTS SHOWED NO SIGNIFICANT CHANGES BETWEEN POST-MIYOGA TO FOLLOW-UP AND PRE-MIYOGA TO FOLLOW-UP FOR VARIABLES THAT SHOWED AN INTERVENTION EFFECT IMMEDIATELY AFTER MIYOGA, NAMELY, CHILDREN'S ATTENTION VARIABLES AND PARENT'S MINDFULNESS. PAIRED T-TESTS SHOWED THAT CHILDREN'S EXECUTIVE FUNCTION AND PHYSICAL FUNCTION AND PARENT'S WELLBEING IMPROVED SIGNIFICANTLY FROM PRE-MIYOGA TO 6-MONTHS FOLLOW-UP WHICH MAY POTENTIALLY REFLECT SLEEPER OR DELAYED EFFECTS OF MIYOGA. CONCLUSION: THIS STUDY IDENTIFIED POSSIBLE DELAYED OR SLEEPER EFFECTS IN CHILDREN'S EXECUTIVE FUNCTION AND PHYSICAL FUNCTION AND PARENT'S WELL-BEING.IMPLICATIONS FOR REHABILITATION6-MONTH FOLLOW-UP EVIDENCE FOR RETENTION OF EFFECTS OF MIYOGA ON CHILDREN'S ATTENTION WAS INCONSISTENT; THEREFORE, BOOSTER SESSIONS OR CONTINUED PRACTICE OF MIYOGA AS A LIFESTYLE OPTION ARE NEEDED TO MAINTAIN AN EFFECT ON ATTENTION.BECAUSE MIYOGA CAN BE PRACTISED DURING DAILY ACTIVITIES, IT MAY PROVIDE ADDITIONAL SUPPORT FOR CHILDREN WITH CP, COMPLEMENTING STANDARD REHABILITATION OPTIONS.BY EMBEDDING MINDFULNESS IN CHILDREN AND PARENTS' DAILY ACTIVITIES, MIYOGA, COULD PROVIDE FAMILIES WITH ACCESSIBLE AND TIME-EFFICIENT MEANS OF LEARNING AND PRACTICING MINDFULNESS.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
5 2348  49 USING THE INTERNATIONAL CLASSIFICATION OF FUNCTIONING, DISABILITY, AND HEALTH MODEL TO GAIN PERSPECTIVE OF THE BENEFITS OF YOGA IN STROKE, MULTIPLE SCLEROSIS, AND CHILDREN TO INFORM PRACTICE FOR CHILDREN WITH CEREBRAL PALSY: A META-ANALYSIS. OBJECTIVE: RESEARCH PERTAINING TO YOGA AND CHILDREN WITH CEREBRAL PALSY (CP) IS NEGLIGIBLE. THE PRIMARY PURPOSE OF THIS STUDY WAS TO DETERMINE THE DOMAINS OF THE INTERNATIONAL CLASSIFICATION OF FUNCTIONING, DISABILITY, AND HEALTH (ICF) MODEL AND LEVELS OF EVIDENCE FOR YOGA AND ADULTS WITH STROKE AND MULTIPLE SCLEROSIS (MS), AND CHILDREN. A SECONDARY PURPOSE WAS TO DECIDE WHETHER ANY INFERENCES COULD BE MADE FOR CHILDREN WITH CP. DESIGN: THIS STUDY INCLUDED A META-ANALYSIS. INTERVENTIONS: A SYSTEMATIC REVIEW WAS PERFORMED OF YOGA AND SAID POPULATIONS. OUTCOME MEASURES WERE CATEGORIZED ACCORDING TO THE ICF MODEL DOMAINS OF BODY STRUCTURES AND FUNCTION, ACTIVITY, AND QUALITY OF LIFE. EFFECT SIZES (ESS) WERE CALCULATED BY USING COHEN'S D. SINCE THERE WERE FEW COMMONALITIES AMONG OUTCOME MEASURES AND REPORTING OF OUTCOMES WITHIN AND AMONG DIAGNOSTIC GROUPS, DIRECT COMPARISONS OF ESS WERE DIFFICULT. HENCE, WE CHOSE TO EVALUATE THE IMPACT OF YOGA AS COMPARED WITH THE CONTROL GROUP OR OTHER PHYSICAL EXERCISE BY USING A GENERAL LINEAR MIXED MODEL. RESULTS: THERE WERE 5 YOGA STUDIES WITH STROKE, 15 WITH MS, AND 12 WITH CHILDREN. STUDIES WITH CHILDREN USED OUTCOMES RELATED TO BODY STRUCTURE AND FUNCTION, WHEREAS THOSE WITH STROKE AND MS USED OUTCOMES ACROSS ALL THREE DOMAINS OF THE ICF. ESS VARIED FROM NEGLIGIBLE TO MEDIUM FOR STROKE, FROM NEGLIGIBLE TO LARGE FOR MS AND CHILDREN. CONCLUSIONS: THE FINDINGS OF THIS META-ANALYSIS INDICATE THAT YOGA IS NO BETTER OR WORSE THAN OTHER EXERCISE MODALITIES AS A TREATMENT INTERVENTION FOR ADULTS WITH STROKE AND MS, AND CHILDREN. GROUP YOGA CLASSES ARE TYPICALLY SOCIAL ENVIRONMENTS THAT CAN CONTRIBUTE TO INCREASED PHYSICAL PROGRESS AND FEELINGS THAT CONTRIBUTE TO QUALITY OF LIFE, WHICH MAY BENEFIT INDIVIDUALS WITH CP. MORE RESEARCH ON YOGA AND PARTICULARLY IN CHILDREN AND ADULTS WITH CP WOULD YIELD VALUABLE INFORMATION FOR CREATING EFFECTIVE AND SAFE YOGA PROGRAMS WITH A RICH ARRAY OF BENEFITS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
6 1250  33 FEASIBILITY STUDY: THE EFFECT OF THERAPEUTIC YOGA ON QUALITY OF LIFE IN CHILDREN HOSPITALIZED WITH CANCER. PURPOSE: TO DESCRIBE THE EFFECT OF THERAPEUTIC YOGA ON CHILD AND PARENTAL REPORTS OF QUALITY OF LIFE IN CHILDREN HOSPITALIZED WITH ONCOLOGICAL DIAGNOSES. METHODS: SIX CHILDREN PARTICIPATED IN 5 YOGA SESSIONS OVER 2 MONTHS. THE PEDSQL 4.0 WAS ADMINISTERED TO EACH CHILD AND PARTICIPATING PARENT/CAREGIVERS AT BASELINE AND AFTER COMPLETION OF THE YOGA INTERVENTION. THE WILCOXON NONPARAMETRIC RANK TEST MEASURED INDIVIDUAL DIFFERENCES OVER TIME. RESULTS: STATISTICALLY SIGNIFICANT DIFFERENCES (P < .05) WERE FOUND IN CHILD PERCEPTION OF GROSS MOTOR FUNCTION. CONCLUSION: THESE FEASIBILITY STUDY DATA SUGGEST THAT THERAPEUTIC YOGA POSITIVELY AFFECTED CHILD PERCEPTION OF GROSS MOTOR FUNCTION MEASURED ON THE PEDSQL 4.0. FURTHER STUDIES ARE NEEDED, INCLUDING A RANDOMIZED CONTROL TRIAL AND WITH A LARGER NUMBER OF PARTICIPANTS, TO CLARIFY AND CONFIRM THE EFFECT OF THERAPEUTIC YOGA.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
7  199  44 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
8 2843  52 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
9  258  55 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
10   34  39 A 12-WEEK IYENGAR YOGA PROGRAM IMPROVED BALANCE AND MOBILITY IN OLDER COMMUNITY-DWELLING PEOPLE: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: EXERCISE THAT CHALLENGES BALANCE CAN IMPROVE MOBILITY AND PREVENT FALLS IN OLDER ADULTS. YOGA AS A PHYSICAL ACTIVITY OPTION FOR OLDER ADULTS IS NOT WELL STUDIED. THIS TRIAL EVALUATED THE FEASIBILITY AND EFFECT OF A 12-WEEK IYENGAR YOGA PROGRAM ON BALANCE AND MOBILITY IN OLDER PEOPLE. METHODS: WE CONDUCTED A BLINDED, PILOT RANDOMIZED CONTROLLED TRIAL WITH INTENTION-TO-TREAT ANALYSIS. PARTICIPANTS WERE 54 COMMUNITY DWELLERS (MEAN AGE 68 YEARS, SD 7.1) NOT CURRENTLY PARTICIPATING IN YOGA OR TAI CHI. THE INTERVENTION GROUP (N = 27) PARTICIPATED IN A 12-WEEK, TWICE-WEEKLY YOGA PROGRAM FOCUSED ON STANDING POSTURES AND RECEIVED A FALL PREVENTION EDUCATION BOOKLET. THE CONTROL GROUP (N = 27) RECEIVED THE EDUCATION BOOKLET ONLY. PRIMARY OUTCOME WAS STANDING BALANCE COMPONENT OF THE SHORT PHYSICAL PERFORMANCE BATTERY WITH ADDITION OF ONE-LEGGED STANCE TIME (STANDING BALANCE). SECONDARY OUTCOMES WERE THE TIMED SIT-TO-STAND TEST, TIMED 4-M WALK, ONE-LEGGED STAND WITH EYES CLOSED, AND SHORT FALLS EFFICACY SCALE-INTERNATIONAL. FEASIBILITY WAS MEASURED BY RECORDING CLASS ATTENDANCE AND ADVERSE EVENTS. RESULTS: FIFTY-TWO PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS. THE INTERVENTION GROUP SIGNIFICANTLY IMPROVED COMPARED WITH CONTROL GROUP ON STANDING BALANCE (MEAN DIFFERENCE = 1.52 SECONDS, 95% CI 0.10-2.96, P = .04), SIT-TO-STAND TEST (MEAN DIFFERENCE = -3.43 SECONDS, 95% CI -5.23 TO -1.64, P < .001), 4-M WALK (MEAN DIFFERENCE = -0.50 SECONDS, 95% CI -0.72 TO -0.28, P < .001), AND ONE-LEGGED STAND WITH EYES CLOSED (MEAN DIFFERENCE = 1.93 SECONDS, 95% CI 0.40-3.46, P = .02). AVERAGE CLASS ATTENDANCE WAS 20 OF 24 CLASSES (83%). NO SERIOUS ADVERSE EVENTS OCCURRED. CONCLUSIONS: THIS TRIAL DEMONSTRATES THE BALANCE AND MOBILITY-RELATED BENEFITS AND FEASIBILITY OF IYENGAR YOGA FOR OLDER PEOPLE. THE FALL PREVENTION EFFECT OF IYENGAR YOGA WARRANTS FURTHER INVESTIGATION.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
11 1748  41 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
12 2831  51 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
13  388  43 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
14  478  42 CLINICAL CASE REPORT: YOGA FOR FATIGUE IN FIVE YOUNG ADULT SURVIVORS OF CHILDHOOD CANCER. PURPOSE: CANCER-RELATED FATIGUE (CRF) IS A DISTRESSING CONSEQUENCE OF CANCER AND ITS TREATMENT. CRF IMPACTS MANY YOUNG ADULT (YA) SURVIVORS OF CHILDHOOD CANCER, COMPROMISING WORK, SOCIAL RELATIONSHIPS, AND DAILY ACTIVITIES. NO SATISFACTORY TREATMENT EXISTS. THIS PILOT STUDY AIMED TO ASSESS THE FEASIBILITY, SAFETY, AND PRELIMINARY EFFICACY OF AN 8-WEEK TWICE/WEEK IYENGAR YOGA (IY) INTERVENTION FOR TREATING PERSISTENT FATIGUE IN YA SURVIVORS OF CHILDHOOD CANCER. METHODS: USING A SINGLE-ARM MIXED-METHODS DESIGN, ADULT CHILDHOOD CANCER SURVIVORS AGED BETWEEN 18 AND 39 YEARS WERE RECRUITED FROM A SURVIVORSHIP CLINIC AT A SINGLE INSTITUTION. QUANTITATIVE: THE PRIMARY OUTCOME WAS FATIGUE AS MEASURED BY THE FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATIGUE. SECONDARY OUTCOMES INCLUDED VITALITY, SOCIAL FUNCTIONING, MULTIDIMENSIONAL FATIGUE, MOOD, AND SLEEP. WEEKLY SELF-REPORT MONITORING DATA WERE COLLECTED. QUALITATIVE: PARTICIPANTS ALSO COMPLETED A POST-INTERVENTION INTERVIEW, MAJOR THEMES EVALUATED. RESULTS: FIVE PARTICIPANTS ENROLLED INTO THE STUDY AND FOUR COMPLETED THE INTERVENTION. ATTENDANCE WAS 92% AND THERE WERE NO ADVERSE EVENTS. BASELINE MOBILITY WAS HIGHLY VARIED, WITH ONE YA HAVING HAD A HEMIPELVECTOMY. QUANTITATIVE DATA REVEALED SIGNIFICANTLY IMPROVED FATIGUE, SOCIAL FUNCTIONING, SOMATIZATION, AND GENERAL AND EMOTIONAL MANIFESTATIONS OF FATIGUE FOLLOWING YOGA. QUALITATIVE DATA CROSS VALIDATED, CLARIFIED, AND EXPANDED UPON THE QUANTITATIVE FINDINGS. CONCLUSIONS: THE STUDY SUGGESTS THAT A BRIEF IY INTERVENTION IS SAFE FOR YA SURVIVORS OF CHILDHOOD CANCER, EVEN FOR THOSE WITH PHYSICAL DISABILITIES. PRELIMINARY EFFICACY WAS DEMONSTRATED FOR THE PRIMARY OUTCOME OF FATIGUE. QUALITATIVE DATA ELUCIDATED ADDITIONAL IMPROVEMENTS, SUCH AS WORK-RELATED SOCIAL FUNCTIONING, AND A SENSE OF CALM AND RELAXATION.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
15 2638  43 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
16 2138  50 THE EFFECTS OF AN 8-WEEK HATHA YOGA INTERVENTION ON EXECUTIVE FUNCTION IN OLDER ADULTS. BACKGROUND: FEW SCIENTIFIC STUDIES HAVE EXAMINED MOVEMENT-BASED EMBODIED CONTEMPLATIVE PRACTICES SUCH AS YOGA AND THEIR EFFECTS ON COGNITION. THE PURPOSE OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO EXAMINE THE EFFECTS OF AN 8-WEEK HATHA YOGA INTERVENTION ON EXECUTIVE FUNCTION MEASURES OF TASK SWITCHING AND WORKING MEMORY CAPACITY. METHODS: COMMUNITY-DWELLING OLDER ADULTS (N = 118; MEAN AGE = 62.0) WERE RANDOMIZED TO ONE OF TWO GROUPS: A HATHA YOGA INTERVENTION OR A STRETCHING-STRENGTHENING CONTROL. BOTH GROUPS PARTICIPATED IN HOUR-LONG EXERCISE CLASSES 3X/WEEK OVER THE 8-WEEK STUDY PERIOD. ALL PARTICIPANTS COMPLETED ESTABLISHED TESTS OF EXECUTIVE FUNCTION INCLUDING THE TASK SWITCHING PARADIGM, N-BACK AND RUNNING MEMORY SPAN AT BASELINE AND FOLLOW-UP. RESULTS: ANALYSIS OF COVARIANCES SHOWED SIGNIFICANTLY SHORTER REACTION TIMES ON THE MIXED AND REPEAT TASK SWITCHING TRIALS (PARTIAL ETA(2) = .04, P < .05) FOR THE HATHA YOGA GROUP. HIGHER ACCURACY WAS RECORDED ON THE SINGLE TRIALS (PARTIAL ETA(2) = .05, P < .05), THE 2-BACK CONDITION OF THE N-BACK (PARTIAL ETA(2) = .08, P < .001), AND PARTIAL RECALL SCORES (PARTIAL ETA(2) = .06, P < .01) OF RUNNING SPAN TASK. CONCLUSIONS: FOLLOWING 8 WEEKS OF YOGA PRACTICE, PARTICIPANTS IN THE YOGA INTERVENTION GROUP SHOWED SIGNIFICANTLY IMPROVED PERFORMANCE ON THE EXECUTIVE FUNCTION MEASURES OF WORKING MEMORY CAPACITY AND EFFICIENCY OF MENTAL SET SHIFTING AND FLEXIBILITY COMPARED WITH THEIR STRETCHING-STRENGTHENING COUNTERPARTS. ALTHOUGH THE UNDERLYING MECHANISMS NEED TO BE INVESTIGATED, THESE RESULTS DEMAND LARGER SYSTEMATIC TRIALS TO THOROUGHLY EXAMINE EFFECTS OF YOGA ON EXECUTIVE FUNCTION AS WELL AS ACROSS OTHER DOMAINS OF COGNITION, AND ITS POTENTIAL TO MAINTAIN OR IMPROVE COGNITIVE FUNCTIONING IN THE AGING PROCESS.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
17 1862  40 RANDOMIZED CONTROLLED TRIAL OF YOGA AMONG A MULTIETHNIC SAMPLE OF BREAST CANCER PATIENTS: EFFECTS ON QUALITY OF LIFE. PURPOSE: THIS STUDY EXAMINES THE IMPACT OF YOGA, INCLUDING PHYSICAL POSES, BREATHING, AND MEDITATION EXERCISES, ON QUALITY OF LIFE (QOL), FATIGUE, DISTRESSED MOOD, AND SPIRITUAL WELL-BEING AMONG A MULTIETHNIC SAMPLE OF BREAST CANCER PATIENTS. PATIENTS AND METHODS: ONE HUNDRED TWENTY-EIGHT PATIENTS (42% AFRICAN AMERICAN, 31% HISPANIC) RECRUITED FROM AN URBAN CANCER CENTER WERE RANDOMLY ASSIGNED (2:1 RATIO) TO A 12-WEEK YOGA INTERVENTION (N = 84) OR A 12-WEEK WAITLIST CONTROL GROUP (N = 44). CHANGES IN QOL (EG, FUNCTIONAL ASSESSMENT OF CANCER THERAPY) FROM BEFORE RANDOM ASSIGNMENT (T1) TO THE 3-MONTH FOLLOW-UP (T3) WERE EXAMINED; PREDICTORS OF ADHERENCE WERE ALSO ASSESSED. NEARLY HALF OF ALL PATIENTS WERE RECEIVING MEDICAL TREATMENT. RESULTS: REGRESSION ANALYSES INDICATED THAT THE CONTROL GROUP HAD A GREATER DECREASE IN SOCIAL WELL-BEING COMPARED WITH THE INTERVENTION GROUP AFTER CONTROLLING FOR BASELINE SOCIAL WELL-BEING AND COVARIATES (P < .0001). SECONDARY ANALYSES OF 71 PATIENTS NOT RECEIVING CHEMOTHERAPY DURING THE INTERVENTION PERIOD INDICATED FAVORABLE OUTCOMES FOR THE INTERVENTION GROUP COMPARED WITH THE CONTROL GROUP IN OVERALL QOL (P < .008), EMOTIONAL WELL-BEING (P < .015), SOCIAL WELL-BEING (P < .004), SPIRITUAL WELL-BEING (P < .009), AND DISTRESSED MOOD (P < .031). SIXTY-NINE PERCENT OF INTERVENTION PARTICIPANTS ATTENDED CLASSES (MEAN NUMBER OF CLASSES ATTENDED BY ACTIVE CLASS PARTICIPANTS = 7.00 +/- 3.80), WITH LOWER ADHERENCE ASSOCIATED WITH INCREASED FATIGUE (P < .001), RADIOTHERAPY (P < .0001), YOUNGER AGE (P < .008), AND NO ANTIESTROGEN THERAPY (P < .02). CONCLUSION: DESPITE LIMITED ADHERENCE, THIS INTENT-TO-TREAT ANALYSIS SUGGESTS THAT YOGA IS ASSOCIATED WITH BENEFICIAL EFFECTS ON SOCIAL FUNCTIONING AMONG A MEDICALLY DIVERSE SAMPLE OF BREAST CANCER SURVIVORS. AMONG PATIENTS NOT RECEIVING CHEMOTHERAPY, YOGA APPEARS TO ENHANCE EMOTIONAL WELL-BEING AND MOOD AND MAY SERVE TO BUFFER DETERIORATION IN BOTH OVERALL AND SPECIFIC DOMAINS OF QOL.	2007	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
18 2560  42 YOGA FOR CHRONIC LOW BACK PAIN: A RANDOMIZED TRIAL. BACKGROUND: PREVIOUS STUDIES INDICATE THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR CHRONIC OR RECURRENT LOW BACK PAIN. OBJECTIVE: TO COMPARE THE EFFECTIVENESS OF YOGA AND USUAL CARE FOR CHRONIC OR RECURRENT LOW BACK PAIN. DESIGN: PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL USING COMPUTER-GENERATED RANDOMIZATION CONDUCTED FROM APRIL 2007 TO MARCH 2010. OUTCOMES WERE ASSESSED BY POSTAL QUESTIONNAIRE. (INTERNATIONAL STANDARD RANDOMISED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN 81079604) SETTING: 13 NON-NATIONAL HEALTH SERVICE PREMISES IN THE UNITED KINGDOM. PATIENTS: 313 ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. INTERVENTION: YOGA (N = 156) OR USUAL CARE (N = 157). ALL PARTICIPANTS RECEIVED A BACK PAIN EDUCATION BOOKLET. THE INTERVENTION GROUP WAS OFFERED A 12-CLASS, GRADUALLY PROGRESSING YOGA PROGRAM DELIVERED BY 12 TEACHERS OVER 3 MONTHS. MEASUREMENTS: SCORES ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RMDQ) AT 3 (PRIMARY OUTCOME), 6, AND 12 (SECONDARY OUTCOMES) MONTHS; PAIN, PAIN SELF-EFFICACY, AND GENERAL HEALTH MEASURES AT 3, 6, AND 12 MONTHS (SECONDARY OUTCOMES). RESULTS: 93 (60%) PATIENTS OFFERED YOGA ATTENDED AT LEAST 3 OF THE FIRST 6 SESSIONS AND AT LEAST 3 OTHER SESSIONS. THE YOGA GROUP HAD BETTER BACK FUNCTION AT 3, 6, AND 12 MONTHS THAN THE USUAL CARE GROUP. THE ADJUSTED MEAN RMDQ SCORE WAS 2.17 POINTS (95% CI, 1.03 TO 3.31 POINTS) LOWER IN THE YOGA GROUP AT 3 MONTHS, 1.48 POINTS (CI, 0.33 TO 2.62 POINTS) LOWER AT 6 MONTHS, AND 1.57 POINTS (CI, 0.42 TO 2.71 POINTS) LOWER AT 12 MONTHS. THE YOGA AND USUAL CARE GROUPS HAD SIMILAR BACK PAIN AND GENERAL HEALTH SCORES AT 3, 6, AND 12 MONTHS, AND THE YOGA GROUP HAD HIGHER PAIN SELF-EFFICACY SCORES AT 3 AND 6 MONTHS BUT NOT AT 12 MONTHS. TWO OF THE 157 USUAL CARE PARTICIPANTS AND 12 OF THE 156 YOGA PARTICIPANTS REPORTED ADVERSE EVENTS, MOSTLY INCREASED PAIN. LIMITATION: THERE WERE MISSING DATA FOR THE PRIMARY OUTCOME (YOGA GROUP, N = 21; USUAL CARE GROUP, N = 18) AND DIFFERENTIAL MISSING DATA (MORE IN THE YOGA GROUP) FOR SECONDARY OUTCOMES. CONCLUSION: OFFERING A 12-WEEK YOGA PROGRAM TO ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN LED TO GREATER IMPROVEMENTS IN BACK FUNCTION THAN DID USUAL CARE. PRIMARY FUNDING SOURCE: ARTHRITIS RESEARCH UK.	2011	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
19 2628  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
20 1165  65 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