1 2854 149 YOGA- AND MEDITATION-BASED LIFESTYLE INTERVENTION INCREASES NEUROPLASTICITY AND REDUCES SEVERITY OF MAJOR DEPRESSIVE DISORDER: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CURRENT INTERVENTIONS FOR MAJOR DEPRESSIVE DISORDER (MDD) ARE SUBOPTIMAL, AND ONLY ONE THIRD RESPOND TO THEM ON INITIAL TREATMENT. NEUROPLASTICITY THEORIES ARE THE BASIS FOR SEVERAL EMERGING TREATMENTS. EVIDENCE ON THE IMPACT OF YOGA, A WELL-KNOWN MIND-BODY INTERVENTION, ON NEUROPLASTICITY IN MDD IS LIMITED. OBJECTIVES: TO DETERMINE THE EFFECTS OF 12-WEEK YOGA- AND MEDITATION-BASED LIFESTYLE INTERVENTION (YMLI) ON DEPRESSION SEVERITY AND SYSTEMIC BIOMARKERS OF NEUROPLASTICITY IN ADULT MDD PATIENTS ON ROUTINE DRUG TREATMENT. METHODS: A TOTAL OF 58 MDD PATIENTS WERE RANDOMIZED INTO YOGA OR CONTROL GROUP. THE SEVERITY OF DEPRESSION WAS ASSESSED WITH BECK DEPRESSION INVENTORY-II SCALE (BDI-II). BLOOD SAMPLES WERE COLLECTED BEFORE AND AFTER INTERVENTION FOR THE MEASUREMENT OF THE BIOMARKERS THAT CHARACTERIZE NEUROPLASTICITY, INCLUDING MIND-BODY COMMUNICATIVE AND CELLULAR HEALTH BIOMARKERS. RESULTS: THERE WAS A SIGNIFICANT DECREASE [DIFFERENCE BETWEEN MEANS, (95% CI)] IN BDI-II SCORE [-5.83 (-7.27, -4.39), P < 0.001] AND SIGNIFICANT INCREASE IN BDNF (NG/ML) [5.48 (3.50, 7.46), P < 0.001] AFTER YMLI COMPARED TO CONTROL GROUP. YMLI SIGNIFICANTLY INCREASED DHEAS, SIRTUIN 1, AND TELOMERASE ACTIVITY LEVELS, AND DECREASED CORTISOL, AND IL-6 LEVELS, IN ADDITION TO DECREASING DNA DAMAGE AND BALANCING OXIDATIVE STRESS. MULTIPLE REGRESSION ANALYSES WERE USED TO ASSOCIATE NEUROPLASTICITY BIOMARKERS WITH DEPRESSION SEVERITY. A 'POST-INTERVENTION CHANGE IN BDNF' X 'GROUP' INTERACTION INDICATED THAT YOGA GROUP HAD MORE BDNF IN ASSOCIATION WITH LESS BDI-II SCORES RELATIVE TO CONTROLS. INCREASED SIRTUIN 1 AND TELOMERASE ACTIVITY AND DECREASED CORTISOL SIGNIFICANTLY PREDICTED THIS ASSOCIATION (ALL P < 0.05). CONCLUSION: THESE RESULTS SUGGEST THAT DECREASE IN DEPRESSION SEVERITY AFTER YMLI IN MDD IS ASSOCIATED WITH IMPROVED SYSTEMIC BIOMARKERS OF NEUROPLASTICITY. THUS YMLI CAN BE CONSIDERED AS A THERAPEUTIC INTERVENTION IN MDD MANAGEMENT. 2018 2 503 33 COMMUNITY-BASED YOGA FOR WOMEN UNDERGOING SUBSTANCE USE DISORDER TREATMENT: A DESCRIPTIVE STUDY. BACKGROUND: WOMEN WITH SUBSTANCE USE DISORDERS (SUD) RECEIVE MEDICATION-ASSISTED TREATMENT (MAT) WITH BEHAVIORAL INTERVENTIONS AND COUNSELING FOR RECOVERY. EVIDENCE SUPPORTS THE USE OF YOGA FOR SUD; HOWEVER FEW STUDIES SPECIFICALLY FEATURE WOMEN. OBJECTIVES: COMMUNITY-BASED YOGA MAY ADD TO HEALTH PROMOTION THROUGH PREFERABLE PHYSICAL ACTIVITY FOR WOMEN IN RECOVERY. THE AIMS OF THIS STUDY ARE TO EXPLORE DEMOGRAPHICS AND QUANTITATIVE MEASURES RELEVANT TO RECOVERY AND CAPTURE AND UNDERSTAND THE SUBJECTIVE EXPERIENCE OF ONE SESSION OF YOGA. STUDY DESIGN: THE STUDY DESIGN INVOLVES DESCRIPTIVE/CROSS-SECTIONAL. METHODOLOGY: WOMEN IN AN INPATIENT SUD CENTER ATTENDING WEEKLY OPTIONAL OFF-SITE YOGA FOR RECOVERY WERE RECRUITED TO CAPTURE FIRST-TIME ATTENDANCE. SURVEY DATA INCLUDED MEDICAL OUTCOMES SURVEY 12-ITEM SHORT-FORM (SF-12), TORONTO MINDFULNESS SCALE (TMS), AND BRIEF RESILIENCE SCALE (BRS), DEMOGRAPHICS, AND NARRATIVE REFLECTIONS. RECRUITMENT OPPORTUNITIES OCCURRED WEEKLY DURING ONGOING HOUR-LONG CLASSES. RESULTS: TWENTY-NINE WOMEN (AVERAGE AGE 36.6) WITH PRIMARILY OPIATE-BASED ADDICTIONS COMPLETED SURVEYS. SF-12 WAS BELOW THE NORMATIVE VALUE OF 50 FOR BOTH SUBSCALES. BRS SCORES SHOWED AVERAGES ON THE LOW END OF NORMAL RESILIENCY. THE FREQUENCY OF RESPONSES TO WRITING PROMPTS CONFIRMED PHYSICAL AND MENTAL WELL-BEING THROUGH YOGA INTERVENTION. WOMEN SHARED POTENTIAL RELAPSE PREVENTION SPECIFICALLY ATTRIBUTED TO THE MINDFULNESS COMPONENT OF THE INTERVENTION. CONCLUSION: THE SF-12, BRS, AND TMS ARE BRIEF, VALID, AND RELIABLE AND CAN BE EASILY INCORPORATED IN CLINICAL PRACTICE OR FUTURE RESEARCH. SUBOPTIMAL SF-12 SCORES WERE FOUND IN WOMEN WITH SUD AND, THEREFORE IMPORTANT TO NOTE IN THE CONTEXT OF RECOVERY TO OPTIMIZE TREATMENT. SUBJECTIVE REPORTS FROM THE PARTICIPANTS FIND COMMUNITY-BASED YOGA AN ENJOYABLE AND BENEFICIAL TYPE OF PHYSICAL ACTIVITY. YOGA MAY BE A VIABLE OPTION FOR COMPREHENSIVE MIND-BODY INTERVENTION FOR THIS POPULATION. 2021 3 1153 29 ENHANCING THE APPEAL OF CARDIAC REHABILITATION FOR WOMEN: DEVELOPMENT AND PILOT TESTING OF A WOMEN-ONLY YOGA CARDIAC REHABILITATION PROGRAMME. AIMS: DESPITE ITS DEMONSTRATED BENEFITS, CARDIAC REHABILITATION (CR) ATTENDANCE, AND COMPLETION IS SUBOPTIMAL, PARTICULARLY IN WOMEN. THE AIMS OF THIS STUDY WERE (I) TO DEVELOP AND PILOT TEST A WOMEN-ONLY YOGA-BASED CR PROGRAMME (THE WOMEN'S YOGA CR PROGRAMME; WYCRP); (II) TO INVESTIGATE PROGRAMME ACCEPTABILITY; AND (III) TO INVESTIGATE ATTENDANCE AND COMPLETION OF THE WYCRP AND CONTINUATION TO PHASE III COMMUNITY-BASED CR. METHODS AND RESULTS: WOMEN ELIGIBLE FOR CR AT A TERTIARY HOSPITAL IN MELBOURNE, AUSTRALIA WERE RECRUITED. OVER A 6-MONTH PERIOD IN 2019, THEY WERE OFFERED THE WYCRP OR USUAL CR. THE WYCRP INVOLVED ATTENDANCE AT A 1-H YOGA SESSION FOLLOWING THE USUAL 1-H MIXED-SEX EDUCATION SESSION, OVER A 7-WEEK PERIOD. PARTICIPANTS COMPLETED PRE- AND POST-PROGRAMME QUESTIONNAIRES AND ATTENDED FOCUS GROUPS TO ASSESS PROGRAMME ACCEPTABILITY. RATES OF ATTENDANCE, COMPLETION, AND CONTINUATION FOR THE WYCRP WERE RECORDED AND COMPARED TO THOSE FOR THE STANDARD CR PROGRAMME OFFERED IN 2018. IN TOTAL, 27 WOMEN WERE ELIGIBLE FOR THE STUDY AND ATTENDED THE INITIAL CR ASSESSMENT. OF THOSE, 22 (81%) ATTENDED THE WYCRP, 1 (4%) ATTENDED USUAL CR, AND 4 (15%) DID NOT ATTEND CR. RATINGS OF PROGRAMME ACCEPTABILITY WERE CONSISTENTLY POSITIVE; QUALITATIVE COMMENTS HIGHLIGHTED BOTH PHYSICAL AND EMOTIONAL BENEFITS. WHILE ATTENDANCE AT THE WYCRP WAS NOT SIGNIFICANTLY HIGHER THAN FOR USUAL CR THE PREVIOUS YEAR (81% VS. 76%; P = 0.40), CR COMPLETION, AND CONTINUATION WERE (95% VS. 56%; P = 0.02, AND 72% VS. 12%; P < 0.001, RESPECTIVELY). CONCLUSION: THIS PILOT STUDY HAS DEMONSTRATED THAT WOMEN-ONLY YOGA-BASED CR IS APPEALING TO WOMEN AND CAN IMPROVE WOMEN'S CR COMPLETION AND CONTINUATION. THESE PRELIMINARY FINDINGS SUPPORT FURTHER DEVELOPMENT OF WOMEN-ONLY AND YOGA-BASED CR OPTIONS. 2021 4 1224 34 FEASIBILITY AND ASSESSMENT OF OUTCOME MEASURES FOR YOGA AS SELF-CARE FOR MINORITIES WITH ARTHRITIS: A PILOT STUDY. BACKGROUND: WHILE THERE IS A GROWING INTEREST IN THE THERAPEUTIC BENEFITS OF YOGA, MINORITY POPULATIONS WITH ARTHRITIS TEND TO BE UNDER-REPRESENTED IN THE RESEARCH. ADDITIONALLY, THERE IS AN ABSENCE OF GUIDANCE IN THE LITERATURE REGARDING THE USE OF MULTICULTURAL TEAMS AND SOCIOCULTURAL HEALTH BELIEFS, WHEN DESIGNING YOGA STUDIES FOR A RACIALLY DIVERSE POPULATION WITH ARTHRITIS. THIS PILOT STUDY EXAMINED THE FEASIBILITY OF OFFERING YOGA AS A SELF-CARE MODALITY TO AN URBAN, BILINGUAL, MINORITY POPULATION WITH OSTEOARTHRITIS (OA) OR RHEUMATOID ARTHRITIS (RA), IN THE WASHINGTON, DC AREA. METHODS: THE PRIMARY OBJECTIVE OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF OFFERING AN 8-WEEK, BILINGUAL YOGA INTERVENTION ADAPTED FOR ARTHRITIS TO A CONVENIENCE SAMPLE OF PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. A RACIALLY DIVERSE INTERDISCIPLINARY RESEARCH TEAM WAS ASSEMBLED TO DESIGN A STUDY TO FACILITATE RECRUITMENT AND RETENTION. THE SECOND OBJECTIVE IDENTIFIED OUTCOME MEASURES TO OPERATIONALIZE POTENTIAL FACILITATORS AND BARRIERS TO SELF-CARE AND SELF-EFFICACY. THE THIRD OBJECTIVE DETERMINED THE FEASIBILITY OF USING COMPUTER-ASSISTED SELF-INTERVIEW (CASI) FOR DATA COLLECTION. RESULTS: ENROLLED PARTICIPANTS (N = 30) WERE MOSTLY FEMALE (93%), SPANISH SPEAKING (69%), AND DIAGNOSED WITH RA (88.5%). FEASIBILITY WAS EVALUATED USING PRACTICALITY, ACCEPTABILITY, ADAPTATION, AND EXPANSION OF AN ARTHRITIS-ADAPTED YOGA INTERVENTION, MODIFIED FOR THIS POPULATION. RECRUITMENT (51%) AND PARTICIPATION (60%) RATES WERE SIMILAR TO PREVIOUS RESEARCH AND CLINICAL EXPERIENCE WITH THE STUDY POPULATION. OF THOSE ENROLLED, 18 STARTED THE INTERVENTION. FOR ADHERENCE, 12 OUT OF 18 (67%) PARTICIPANTS COMPLETED THE INTERVENTION. ALL (100%), WHO COMPLETED THE INTERVENTION, CONTINUED TO PRACTICE YOGA 3 MONTHS AFTER COMPLETING THE STUDY. USING NONPARAMETRIC TESTS, SELECTED OUTCOME MEASURES SHOWED A MEASURABLE CHANGE POST-INTERVENTION SUGGESTING APPROPRIATE USE IN FUTURE STUDIES. AN IN-PERSON COMPUTERIZED QUESTIONNAIRE WAS DETERMINED TO BE A FEASIBLE METHOD OF DATA COLLECTION. CONCLUSIONS: FINDINGS FROM THIS PILOT STUDY CONFIRM THE FEASIBILITY OF OFFERING YOGA TO THIS RACIALLY/ETHNICALLY DIVERSE POPULATION WITH ARTHRITIS. THIS ARTICLE PROVIDES RECRUITMENT/RETENTION RATES, OUTCOME MEASURES WITH ERROR RATES, AND DATA COLLECTION RECOMMENDATIONS FOR A PREVIOUSLY UNDER-REPRESENTED POPULATION. SUGGESTIONS INCLUDE ALLOCATING RESOURCES FOR TRANSLATION AND USING A MULTICULTURAL DESIGN TO FACILITATE RECRUITMENT AND RETENTION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT01617421. 2018 5 258 41 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 6 144 32 A QUALITATIVE APPROACH EXPLORING THE ACCEPTABILITY OF YOGA FOR MINORITIES LIVING WITH ARTHRITIS: 'WHERE ARE THE PEOPLE WHO LOOK LIKE ME?' OBJECTIVES: TO EXAMINE THE ACCEPTABILITY OF YOGA RESEARCH TAILORED TO RECRUIT AND RETAIN A MINORITY POPULATION (BOTH ENGLISH AND SPANISH SPEAKING) WITH ARTHRITIS. YOGA RESEARCH FOR ARTHRITIS OFTEN UNDERREPRESENTS MINORITIES AND ACCEPTABILITY FOR THIS POPULATION HAS NOT PREVIOUSLY BEEN INVESTIGATED. DESIGN: ACCEPTABILITY WAS EVALUATED USING RETENTION, ADHERENCE, JOURNALS, AND SEMI-STRUCTURED EXIT INTERVIEWS FROM TWELVE PARTICIPANTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS UNDERGOING AN 8-WEEK YOGA INTERVENTION. JOURNAL QUOTES WERE ANALYZED USING CONTENT ANALYSIS TECHNIQUES. NVIVO SOFTWARE WAS USED TO ORGANIZE TRANSCRIPTS AND ASSEMBLE THEMES. TWO METHODS OF TRIANGULATION (DATA AND INVESTIGATOR) WERE USED TO OVERCOME POTENTIAL BIAS FROM A SINGLE-PERSPECTIVE INTERPRETATION. EXIT INTERVIEW COMMENTS WERE CONTENT ANALYZED USING A CARD SORT METHOD. THE STUDY WAS DESIGNED WITH A CULTURAL INFRASTRUCTURE INCLUDING A MULTICULTURAL RESEARCH TEAM, TRANSLATORS, AND BILINGUAL MATERIALS AND CLASSES, TO FACILITATE TRUST AND ACCEPTABILITY FOR PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. SETTING: WASHINGTON, D.C. METROPOLITAN AREA, USA. RESULTS: ON AVERAGE PARTICIPANTS ATTENDED 10 OF 16 CLASSES, WITH HOME PRACTICE 2-3DAYS A WEEK. ALL WHO COMPLETED WERE STILL PRACTICING YOGA THREE-MONTHS LATER. QUALITATIVE NARRATIVE ANALYSIS IDENTIFIED MAJOR THEMES RELATED TO FACILITATING FACTORS AND BARRIERS FOR YOGA PRACTICE, SELF-EFFICACY, AND SUPPORT. PARTICIPANT COMMENTS INDICATED THAT OFFERING AN ARTHRITIS-BASED YOGA INTERVENTION AND USING A CULTURALLY CONGRUENT RESEARCH DESIGN WAS FOUND TO BE ACCEPTABLE. CONCLUSIONS: AS YOGA RESEARCH GROWS, THERE IS A NEED TO UNDERSTAND AND PROMOTE ACCEPTABILITY FOR TYPICALLY UNDER-REPRESENTED POPULATIONS. THIS STUDY ATTEMPTS TO INFORM THE EXPANSION OF MULTICULTURAL RESEARCH DESIGNED TO RECRUIT AND RETAIN THOSE FROM DIVERSE BACKGROUNDS. 2017 7 122 39 A PILOT STUDY OF YOGA AS SELF-CARE FOR ARTHRITIS IN MINORITY COMMUNITIES. BACKGROUND: WHILE ARTHRITIS IS THE MOST COMMON CAUSE OF DISABILITY, NON-HISPANIC BLACKS AND HISPANICS EXPERIENCE WORSE ARTHRITIS IMPACT DESPITE HAVING THE SAME OR LOWER PREVALENCE OF ARTHRITIS COMPARED TO NON-HISPANIC WHITES. PEOPLE WITH ARTHRITIS WHO EXERCISE REGULARLY HAVE LESS PAIN, MORE ENERGY, AND IMPROVED SLEEP, YET ARTHRITIS IS ONE OF THE MOST COMMON REASONS FOR LIMITING PHYSICAL ACTIVITY. MIND-BODY INTERVENTIONS, SUCH AS YOGA, THAT TEACH STRESS MANAGEMENT ALONG WITH PHYSICAL ACTIVITY MAY BE WELL SUITED FOR INVESTIGATION IN BOTH OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS. YOGA USERS ARE PREDOMINANTLY WHITE, FEMALE, AND COLLEGE EDUCATED. THERE ARE FEW STUDIES THAT EXAMINE YOGA IN MINORITY POPULATIONS; NONE ADDRESS ARTHRITIS. THIS PAPER PRESENTS A STUDY PROTOCOL EXAMINING THE FEASIBILITY AND ACCEPTABILITY OF PROVIDING YOGA TO AN URBAN, MINORITY POPULATION WITH ARTHRITIS. METHODS/DESIGN: IN THIS ONGOING PILOT STUDY, A CONVENIENCE SAMPLE OF 20 MINORITY ADULTS DIAGNOSED WITH EITHER OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS UNDERGO AN 8-WEEK PROGRAM OF YOGA CLASSES. IT IS BELIEVED THAT BY ATTENDING YOGA CLASSES DESIGNED FOR PATIENTS WITH ARTHRITIS, WITH RACIALLY CONCORDANT INSTRUCTORS; ACCEPTABILITY OF YOGA AS AN ADJUNCT TO STANDARD ARTHRITIS TREATMENT AND SELF-CARE WILL BE ENHANCED. SELF-CARE IS DEFINED AS ADOPTING BEHAVIORS THAT IMPROVE PHYSICAL AND MENTAL WELL-BEING. THIS CONCEPT IS QUANTIFIED THROUGH COLLECTING PATIENT-REPORTED OUTCOME MEASURES RELATED TO SPIRITUAL GROWTH, HEALTH RESPONSIBILITY, INTERPERSONAL RELATIONS, AND STRESS MANAGEMENT. ADDITIONAL MEASURES COLLECTED DURING THIS STUDY INCLUDE: PHYSICAL FUNCTION, ANXIETY/DEPRESSION, FATIGUE, SLEEP DISTURBANCE, SOCIAL ROLES, AND PAIN; AS WELL AS BASELINE DEMOGRAPHIC AND CLINICAL DATA. FIELD NOTES, QUANTITATIVE AND QUALITATIVE DATA REGARDING FEASIBILITY AND ACCEPTABILITY ARE ALSO COLLECTED. ACCEPTABILITY IS DETERMINED BY RESPONSE/RETENTION RATES, POSITIVE QUALITATIVE DATA, AND CONTINUING YOGA PRACTICE AFTER THREE MONTHS. DISCUSSION: THERE ARE A NUMBER OF CHALLENGES IN RECRUITING AND RETAINING PARTICIPANTS FROM A COMMUNITY CLINIC SERVING MINORITY POPULATIONS. ADOPTING BEHAVIORS THAT IMPROVE WELL-BEING AND QUALITY OF LIFE INCLUDE THOSE THAT INTEGRATE MENTAL HEALTH (MIND) AND PHYSICAL HEALTH (BODY). FEW STUDIES HAVE EXAMINED OFFERING INTEGRATIVE MODALITIES TO THIS POPULATION. THIS PILOT WAS UNDERTAKEN TO QUANTIFY MEASURES OF FEASIBILITY AND ACCEPTABILITY THAT WILL BE USEFUL WHEN EVALUATING FUTURE PLANS FOR EXPANDING THE STUDY OF YOGA IN URBAN, MINORITY POPULATIONS WITH ARTHRITIS. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT01617421. 2013 8 2831 30 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 9 1392 43 IMPACT OF YOGA AND MEDITATION ON CELLULAR AGING IN APPARENTLY HEALTHY INDIVIDUALS: A PROSPECTIVE, OPEN-LABEL SINGLE-ARM EXPLORATORY STUDY. THIS STUDY WAS DESIGNED TO EXPLORE THE IMPACT OF YOGA AND MEDITATION BASED LIFESTYLE INTERVENTION (YMLI) ON CELLULAR AGING IN APPARENTLY HEALTHY INDIVIDUALS. DURING THIS 12-WEEK PROSPECTIVE, OPEN-LABEL, SINGLE ARM EXPLORATORY STUDY, 96 APPARENTLY HEALTHY INDIVIDUALS WERE ENROLLED TO RECEIVE YMLI. THE PRIMARY ENDPOINTS WERE ASSESSMENT OF THE CHANGE IN LEVELS OF CARDINAL BIOMARKERS OF CELLULAR AGING IN BLOOD FROM BASELINE TO WEEK 12, WHICH INCLUDED DNA DAMAGE MARKER 8-HYDROXY-2'-DEOXYGUANOSINE (8-OH2DG), OXIDATIVE STRESS MARKERS REACTIVE OXYGEN SPECIES (ROS), AND TOTAL ANTIOXIDANT CAPACITY (TAC), AND TELOMERE ATTRITION MARKERS TELOMERE LENGTH AND TELOMERASE ACTIVITY. THE SECONDARY ENDPOINTS WERE ASSESSMENT OF METABOTROPHIC BLOOD BIOMARKERS ASSOCIATED WITH CELLULAR AGING, WHICH INCLUDED CORTISOL, BETA-ENDORPHIN, IL-6, BDNF, AND SIRTUIN-1. AFTER 12 WEEKS OF YMLI, THERE WERE SIGNIFICANT IMPROVEMENTS IN BOTH THE CARDINAL BIOMARKERS OF CELLULAR AGING AND THE METABOTROPHIC BIOMARKERS INFLUENCING CELLULAR AGING COMPARED TO BASELINE VALUES. THE MEAN LEVELS OF 8-OH2DG, ROS, CORTISOL, AND IL-6 WERE SIGNIFICANTLY LOWER AND MEAN LEVELS OF TAC, TELOMERASE ACTIVITY, BETA-ENDORPHIN, BDNF, AND SIRTUIN-1 WERE SIGNIFICANTLY INCREASED (ALL VALUES P < 0.05) POST-YMLI. THE MEAN LEVEL OF TELOMERE LENGTH WAS INCREASED BUT THE FINDING WAS NOT SIGNIFICANT (P = 0.069). YMLI SIGNIFICANTLY REDUCED THE RATE OF CELLULAR AGING IN APPARENTLY HEALTHY POPULATION. 2017 10 1165 47 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 11 151 35 A QUALITATIVE INVESTIGATION TO INFORM YOGA INTERVENTION RECRUITMENT PRACTICES FOR RACIAL/ETHNIC MINORITY ADOLESCENTS IN OUTPATIENT MENTAL HEALTH TREATMENT. OBJECTIVE: YOGA IS RECOGNIZED AS AN EFFECTIVE APPROACH TO IMPROVING OVERALL PHYSICAL AND MENTAL HEALTH; HOWEVER, THERE MAY BE PERCEIVED BARRIERS TO YOGA PARTICIPATION, PARTICULARLY AMONG POPULATIONS MOST AT RISK FOR MENTAL HEALTH ISSUES. WE CONDUCTED QUALITATIVE FORMATIVE RESEARCH TO HELP INFORM RECRUITMENT PRACTICES FOR A FUTURE STUDY AND TO SPECIFICALLY UNDERSTAND THE BARRIERS AND FACILITATORS TO ENGAGEMENT IN YOGA PRACTICE AMONG RACIAL/ETHNIC MINORITY ADOLESCENTS, AS WELL AS ADOLESCENTS IN OUTPATIENT MENTAL HEALTH TREATMENT. METHODS: QUALITATIVE DATA WERE COLLECTED AT A COMMUNITY HEALTH CLINIC THAT SERVES LOW INCOME FAMILIES IN SOUTHEASTERN FLORIDA. USING SEMI STRUCTURED INTERVIEWS WITH RACIAL AND ETHNIC MINORITY ADOLESCENTS BETWEEN 12 AND 17 YEARS OLD, PARTICIPANTS WERE ASKED ABOUT BELIEFS AND PERCEPTIONS ABOUT YOGA, AS WELL AS RECOMMENDATIONS ON RECRUITING PEERS. A THEMATIC ANALYSIS APPROACH WAS USED TO IDENTIFY AND EXAMINE COMMON THEMES. RESULTS: TWENTY INTERVIEWS WERE CONDUCTED AND EIGHT MAJOR THEMES EMERGED FROM THE DATA. THEMES WERE GROUPED AS (1) FACILITATORS TO RECRUITMENT AND (2) BARRIERS TO RECRUITMENT. INTERPRETATION: ADVERTISING FREE YOGA THAT EMPHASIZES THE SOCIAL, PHYSICAL, AND MENTAL BENEFITS CAN HELP ASSUAGE NEGATIVE PERCEPTIONS OF YOGA AND PROMOTE THE ADVANTAGES OF YOGA AMONG TEENAGERS. HAVING RECRUITMENT MATERIALS AND MODALITIES THAT HIGHLIGHT INCLUSIVITY OF ALL GENDERS AND PHYSICAL ABILITIES IN THE YOGA CLASSES ARE ALSO IMPORTANT IN FACILITATING PARTICIPATION. UNDERSTANDING PERCEPTIONS OF YOGA, AS WELL AS PERCEIVED BARRIERS AND FACILITATORS, AMONG RACIALLY/ETHNICALLY DIVERSE ADOLESCENTS IN OUTPATIENT MENTAL HEALTH TREATMENT, CAN ASSIST RECRUITMENT EFFORTS, INCREASE YOGA INTERVENTION PARTICIPATION, AND ULTIMATELY, IMPROVE MENTAL HEALTH OUTCOMES FOR UNDERSERVED POPULATIONS. 2020 12 518 36 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013 13 162 40 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 14 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 15 312 37 AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL OF A 12-WEEK YOGA VERSUS EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME: FEASIBILITY AND ACCEPTABILITY. OBJECTIVES: THE PRIMARY OBJECTIVES OF THIS PILOT TRIAL WERE TO ASSESS THE STUDY FEASIBILITY AND ACCEPTABILITY OF THE 12-WEEK YOGA AND EDUCATIONAL FILM PROGRAMS FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS) IN PREPARATION FOR A FUTURE RANDOMIZED CONTROLLED TRIAL (RCT). MATERIALS AND METHODS: THIS PILOT, PARALLEL-ARM, RANDOMIZED FEASIBILITY TRIAL WAS CONDUCTED AT TWO SITES, MORGANTOWN, WV AND COLUMBUS, OH. YOGA GROUP PARTICIPANTS ATTENDED 75-MIN IYENGAR YOGA CLASSES, TWICE WEEKLY FOR 4 WEEKS, THEN ONCE A WEEK FOR 8 WEEKS (16 TOTAL CLASSES), AND COMPLETED A 30-MIN HOMEWORK ROUTINE ON NONCLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS ATTENDED ONCE WEEKLY, 75-MIN CLASSES (12 TOTAL CLASSES), WHICH INCLUDED INFORMATION ON RLS AND OTHER SLEEP DISORDERS, RLS MANAGEMENT INCLUDING SLEEP HYGIENE PRACTICES, AND COMPLEMENTARY THERAPIES. FEASIBILITY AND ACCEPTABILITY OUTCOMES INCLUDED PROGRAM SATISFACTION AND RECRUITMENT, RETENTION, AND ADHERENCE RATES. IN ADDITION, PARTICIPANTS WERE ASKED THEIR PREFERENCES REGARDING THREE YOGA CLASS SCHEDULE SCENARIOS FOR A FUTURE STUDY. ATTENDANCE, YOGA, AND TREATMENT LOGS WERE COLLECTED WEEKLY. PROGRAM EVALUATION AND YOGA SCHEDULING QUESTIONNAIRES WERE COLLECTED AT WEEK 12. RESULTS: FORTY-ONE ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EDUCATIONAL FILM (N = 22) PROGRAM. THIRTY PARTICIPANTS (73%) COMPLETED THE PROGRAM. YOGA AND EDUCATION GROUP PARTICIPANTS ATTENDED AN AVERAGE OF 13.0 +/- 0.84 (81%) AND 10.3 +/- 0.3 CLASSES (85%), RESPECTIVELY. PARTICIPANTS FROM BOTH GROUPS INDICATED SATISFACTION WITH THE STUDY. ALL YOGA GROUP RESPONDENTS TO THE PROGRAM EVALUATION REPORTED THEY WOULD LIKELY (N = 6) OR VERY LIKELY (N = 7) CONTINUE YOGA PRACTICE; 86.7% OF EDUCATION GROUP RESPONDENTS (13 OF 15) INDICATED THAT THEY WERE LIKELY (N = 7) OR VERY LIKELY (N = 6) TO MAKE LASTING CHANGES BASED ON WHAT THEY HAD LEARNED. THE PREFERRED SCHEDULE FOR A FUTURE STUDY WAS A 16-WEEK STUDY WITH ONCE-WEEKLY YOGA CLASSES. CONCLUSIONS: THE FINDINGS OF THIS STUDY SUGGEST THAT A LARGER RCT COMPARING YOGA WITH AN EDUCATIONAL FILM GROUP FOR THE MANAGEMENT OF RLS IS FEASIBLE. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT03570515; 02/01/2017. 2022 16 2628 34 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 17 2763 28 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893. 2021 18 74 38 A GROUP-BASED YOGA THERAPY INTERVENTION FOR URINARY INCONTINENCE IN WOMEN: A PILOT RANDOMIZED TRIAL. OBJECTIVE: THE AIM OF THIS STUDY IS TO EXAMINE THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION FOR MIDDLE-AGED AND OLDER WOMEN WITH URINARY INCONTINENCE. METHODS: WE CONDUCTED A PILOT RANDOMIZED TRIAL OF AMBULATORY WOMEN AGED 40 YEARS AND OLDER WITH STRESS, URGENCY, OR MIXED-TYPE INCONTINENCE. WOMEN WERE RANDOMIZED TO A 6-WEEK YOGA THERAPY PROGRAM (N = 10) CONSISTING OF TWICE WEEKLY GROUP CLASSES AND ONCE WEEKLY HOME PRACTICE OR A WAIT-LIST CONTROL GROUP (N = 9). ALL PARTICIPANTS ALSO RECEIVED WRITTEN PAMPHLETS ABOUT STANDARD BEHAVIORAL SELF-MANAGEMENT STRATEGIES FOR INCONTINENCE. CHANGES IN INCONTINENCE WERE ASSESSED WITH 7-DAY VOIDING DIARIES. RESULTS: THE MEAN (SD) AGE WAS 61.4 (8.2) YEARS, AND THE MEAN BASELINE FREQUENCY OF INCONTINENCE WAS 2.5 (1.3) EPISODES/D. AFTER 6 WEEKS, THE TOTAL INCONTINENCE FREQUENCY DECREASED BY 70% (1.8 [0.9] FEWER EPISODES/D) IN THE YOGA THERAPY VERSUS 13% (0.3 [1.7] FEWER EPISODES/D) IN THE CONTROL GROUP (P = 0.049). PARTICIPANTS IN THE YOGA THERAPY GROUP ALSO REPORTED AN AVERAGE OF 71% DECREASE IN STRESS INCONTINENCE FREQUENCY (0.7 [0.8] FEWER EPISODES/D) COMPARED WITH A 25% INCREASE IN CONTROLS (0.2 [1.1] MORE EPISODES/D) (P = 0.039). NO SIGNIFICANT DIFFERENCES IN REDUCTION IN URGENCY INCONTINENCE WERE DETECTED BETWEEN THE YOGA THERAPY VERSUS CONTROL GROUPS (1.0 [1.0] VERSUS 0.5 [0.5] FEWER EPISODES/D; P = 0.20). ALL WOMEN STARTING THE YOGA THERAPY PROGRAM COMPLETED AT LEAST 90% OF THE GROUP CLASSES AND PRACTICE SESSIONS. TWO PARTICIPANTS IN EACH GROUP REPORTED ADVERSE EVENTS UNRELATED TO THE INTERVENTION. CONCLUSIONS: FINDINGS PROVIDE PRELIMINARY EVIDENCE TO SUPPORT THE FEASIBILITY, EFFICACY, AND SAFETY OF A GROUP-BASED YOGA THERAPY INTERVENTION TO IMPROVE URINARY INCONTINENCE IN WOMEN. 2014 19 1192 37 EXAMINING A THERAPEUTIC YOGA PROGRAM FOR PROSTATE CANCER SURVIVORS. BACKGROUND: IN THE EARLIER STAGES OF PROSTATE CANCER, EFFECTIVE TREATMENTS HAVE CREATED A NEED FOR RESEARCH TO FOCUS ON PRACTICES THAT MAY IMPROVE QUALITY OF LIFE THROUGHOUT SURVIVORSHIP. PHYSICAL ACTIVITY IS A SIGNIFICANT SUPPORTIVE CARE MANAGEMENT STRATEGY FOR PROSTATE CANCER SURVIVORS, THOUGH THE OPTIMAL MODALITY IS NOT YET UNDERSTOOD. HYPOTHESES: THE AUTHORS HYPOTHESIZED THAT YOGA WOULD BE A FEASIBLE PHYSICAL ACTIVITY OPTION FOR PROSTATE CANCER SURVIVORS AND THEIR SUPPORT PERSONS AND THAT THE INCORPORATION OF SOCIAL SUPPORT WOULD INCREASE PHYSICAL ACTIVITY ADHERENCE. METHODS: THIS 14-WEEK FEASIBILITY STUDY INVOLVED A 7-WEEK CLASS-BASED YOGA PROGRAM (ADHERENCE PHASE), FOLLOWED BY 7 WEEKS OF SELF-SELECTED PHYSICAL ACTIVITY (MAINTENANCE PHASE). DEMOGRAPHIC INFORMATION, PHYSICAL ACTIVITY BEHAVIOR, QUALITY OF LIFE, FATIGUE, STRESS, MOOD, AND FITNESS VARIABLES WERE ASSESSED AT 3 TIME POINTS. PROSTATE CANCER SURVIVORS' PERCEIVED SOCIAL SUPPORT WAS RATED DURING YOGA AND AFTER YOGA. RESULTS: CLASS ATTENDANCE WAS 6.1 AND 5.8 FOR PROSTATE CANCER SURVIVORS (N = 15) AND THEIR SUPPORT PERSONS (N = 10), RESPECTIVELY, FOR THE 7 CLASSES. LEVELS OF PERCEIVED SOCIAL SUPPORT WERE HIGHER FOR THOSE WHO BROUGHT A SUPPORT PERSON. SIGNIFICANT IMPROVEMENTS WITH REGARD TO STRESS, FATIGUE, AND MOOD BEFORE AND AFTER YOGA CLASS (ALL PS < .05) WERE REPORTED BY ALL PARTICIPANTS. NO CLINICALLY SIGNIFICANT CHANGES WERE NOTED ON PROSTATE CANCER SURVIVOR'S QUALITY OF LIFE OR FATIGUE OVER THE COURSE OF THE 14-WEEK STUDY. CONCLUSIONS: YOGA IS A FEASIBLE PHYSICAL ACTIVITY OPTION FOR PROSTATE CANCER SURVIVORS. THE PROGRAM HAD A PROMISING UPTAKE RATE, HIGH PROGRAM ADHERENCE RATE, AND THERE WERE ACUTE PROGRAM BENEFITS WITH REGARD TO STRESS, FATIGUE, AND MOOD FOR ALL PARTICIPANTS. FUTURE EXAMINATION IS WARRANTED WITH REGARD TO CHRONIC BENEFITS AND GROUP COHESION INFLUENCES ON LEVELS OF PERCEIVED SOCIAL SUPPORT. 2013 20 133 44 A PRAGMATIC PREFERENCE TRIAL OF THERAPEUTIC YOGA AS AN ADJUNCT TO GROUP COGNITIVE BEHAVIOUR THERAPY VERSUS GROUP CBT ALONE FOR DEPRESSION AND ANXIETY. BACKGROUND: YOGA HAS SEVERAL MECHANISMS THAT MAKE IT A PROMISING TREATMENT FOR DEPRESSION AND ANXIETY, INCLUDING PHYSICAL ACTIVITY, BEHAVIOURAL ACTIVATION, AND MINDFULNESS. FOLLOWING POSITIVE OUTCOMES FROM ADAPTED CBT INTERVENTIONS INCORPORATING MINDFULNESS-BASED PRACTICES, THIS STUDY EXPLORED THE EFFECTS OF A THERAPEUTIC YOGA PROGRAM AS AN ADJUNCT TO GROUP-BASED CBT FOR DEPRESSION OR ANXIETY. METHODS: THIS WAS A PRAGMATIC PREFERENCE TRIAL INVOLVING ADULTS DIAGNOSED WITH DEPRESSION OR ANXIETY IN A REGIONAL PRIMARY MENTAL HEALTHCARE SERVICE (N = 59), COMPARING TRANSDIAGNOSTIC GROUP CBT (N = 27) WITH TRANSDIAGNOSTIC GROUP CBT COMBINED WITH AN ADJUNCT THERAPEUTIC YOGA PROGRAM (N = 32). A PREFERENCE RECRUITMENT DESIGN ALLOWED ELIGIBLE PARTICIPANTS (N = 35) TO SELF-SELECT INTO THE ADJUNCT PROGRAM. THE DEPRESSION ANXIETY STRESS SCALE-21 (DASS) WAS ASSESSED AT BASELINE, POST-INTERVENTION, AND THREE-MONTHS FOLLOW UP. RESULTS: CBT + YOGA WAS AN ACCEPTABLE ALTERNATIVE TO CBT ALONE. SIGNIFICANT REDUCTIONS WERE OBSERVED IN TOTAL DASS SCORES AND THE 3 SUBSCALES OF THE DASS FOR BOTH GROUPS, HOWEVER CBT + YOGA SHOWED SIGNIFICANTLY LOWER DEPRESSIVE AND ANXIETY SYMPTOMS POST-INTERVENTION, COMPARED TO CBT ALONE. CBT + YOGA ALSO SHOWED SUSTAINED REDUCTIONS IN DEPRESSIVE SYMPTOMS OVER THREE-MONTHS, AND MORE RAPID REDUCTIONS IN DEPRESSIVE SYMPTOMS, COMPARED TO CBT ALONE. LIMITATIONS: THESE FINDINGS SHOULD BE CONSIDERED PRELIMINARY DUE TO THE MODERATE SAMPLE SIZE, WITH A RIGOROUS RANDOMISED CONTROL TRIAL NECESSARY TO DEFINITIVELY SUPPORT THE INTEGRATION OF YOGA WITHIN MENTAL HEALTH CARE TO AUGMENT THE BENEFITS AND UPTAKE OF TRANSDIAGNOSTIC CBT FOR DEPRESSION AND ANXIETY. CONCLUSIONS: COMPLEMENTING OTHER MINDFULNESS-BASED PRACTICES, THERAPEUTIC YOGA SHOWS PROMISE AS AN ADJUNCT TO TRANSDIAGNOSTIC CBT. 2022