1 16 120 "SMOKING DOES NOT GO WITH YOGA:" A QUALITATIVE STUDY OF WOMEN'S PHENOMENOLOGICAL PERCEPTIONS DURING YOGA AND SMOKING CESSATION. INTRODUCTION: SMOKING CESSATION IS OFTEN ACCOMPANIED BY WITHDRAWAL SYMPTOMS, CIGARETTE CRAVING, INCREASED NEGATIVE AFFECT, AND INCREASED EXPERIENCE OF STRESS. BECAUSE YOGA HAS BEEN SHOWN TO REDUCE STRESS AND NEGATIVE AFFECT, IT MAY BE AN EFFECTIVE AID TO SMOKING CESSATION. THE OBJECTIVE OF THIS STUDY WAS TO EXAMINE WOMEN'S PHENOMENOLOGICAL EXPERIENCES OF VINYASA YOGA AS PART OF A SMOKING CESSATION PROGRAM. METHODS: FOCUS GROUPS WERE CONDUCTED POST-INTERVENTION WITH WOMEN (N = 20) WHO PARTICIPATED IN A PILOT RANDOMIZED CONTROLLED TRIAL OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION. THE 8-WEEK VINYASA YOGA INTERVENTION INCLUDED TWICE WEEKLY 60-MINUTE CLASSES THAT INVOLVED BREATHING EXERCISES, POSTURES (ASANAS), AND RELAXATION TECHNIQUES. FOCUS GROUPS WERE AUDIO RECORDED AND TRANSCRIBED. THEMATIC ANALYSIS FOCUSED ON DESCRIPTIONS OF YOGA, BREATHING, AND BODILY SENSATIONS INCLUDING CIGARETTE CRAVING. RESULTS: FOCUS GROUP PARTICIPANTS DESCRIBED VINYASA YOGA AS PHYSICALLY CHALLENGING. MOST REPORTED DELIBERATE USE OF YOGIC BREATHING TO COPE WITH CIGARETTE CRAVING AND STRESS. OTHER PERCEIVED EFFECTS INCLUDED RELAXATION AND AN INCREASED SENSE OF BODY AWARENESS AND WELLBEING. CONCLUSIONS: PARTICIPANTS VIEWED YOGA AS POSITIVE AND POTENTIALLY HELPFUL FOR QUITTING SMOKING. YOGA MAY BE AN EFFECTIVE ADJUNCT FOR SMOKING CESSATION. 2016 2 2039 56 TESTING THE EFFICACY OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION: DESIGN AND METHODS OF THE BREATHEASY TRIAL. INTRODUCTION: SMOKERS TRYING TO QUIT ENCOUNTER MANY CHALLENGES INCLUDING NICOTINE WITHDRAWAL SYMPTOMS, CIGARETTE CRAVING, INCREASED STRESS AND NEGATIVE MOOD AND CONCERN REGARDING WEIGHT GAIN. THESE PHENOMENA MAKE IT DIFFICULT TO SUCCESSFULLY QUIT SMOKING. STUDIES IN NON-SMOKING POPULATIONS SHOW THAT YOGA REDUCES STRESS AND NEGATIVE MOOD AND IMPROVES WEIGHT CONTROL. BY INCREASING MINDFULNESS WE ANTICIPATE THAT YOGA MAY ALSO IMPROVE SMOKERS' ABILITY TO COPE WITH THE NEGATIVE SYMPTOMS ASSOCIATED WITH QUITTING. YOGA MAY ALSO IMPROVE COGNITIVE DELIBERATION WHICH IS NEEDED TO MAKE EFFECTIVE CHOICES AND AVOID SMOKING IN TEMPTING SITUATIONS. METHODS/DESIGN: THE BREATHEASY STUDY IS A RIGOROUS, RANDOMIZED CONTROLLED CLINICAL TRIAL EXAMINING THE EFFICACY OF IYENGAR YOGA AS A COMPLEMENTARY THERAPY TO COGNITIVE-BEHAVIORAL THERAPY FOR SMOKING CESSATION. ALL PARTICIPANTS ARE GIVEN AN 8-WEEK PROGRAM OF SMOKING CESSATION CLASSES, AND ARE RANDOMIZED TO EITHER TWICE WEEKLY YOGA (YOGA) OR TWICE-WEEKLY HEALTH AND WELLNESS CLASSES WHICH SERVE AS A CONTROL FOR CONTACT AND PARTICIPANT BURDEN (CTL). ASSESSMENTS ARE CONDUCTED AT BASELINE, 8 WEEKS, 3, 6, AND 12 MONTHS OF FOLLOW-UP. THE PRIMARY OUTCOME IS PROLONGED ABSTINENCE USING AN INTENTION-TO-TREAT APPROACH. MULTIPLE INTERNAL AND EXTERNAL AUDITS USING BLIND DATA COLLECTION ARE EMPLOYED TO ENSURE TREATMENT FIDELITY AND RELIABILITY OF STUDY RESULTS. TO UNDERSTAND WHY YOGA MAY BE MORE EFFECTIVE THAN CTL, WE WILL EXAMINE THE MECHANISMS OF ACTION (I.E., MEDIATORS) UNDERLYING INTERVENTION EFFICACY. WE WILL EXAMINE THE MAINTENANCE OF YOGA PRACTICE AND SMOKING STATUS AT EACH FOLLOW-UP. FOCUS GROUPS AND INTERVIEWS WILL BE USED TO ENRICH OUR UNDERSTANDING OF THE RELATIONSHIP OF YOGA PRACTICE AND SMOKING ABSTINENCE. CONCLUSIONS: THIS STUDY WILL PROVIDE A STRINGENT TEST OF THE RELATIVE EFFICACY OF YOGA COMPARED TO A CONDITION THAT CONTROLS FOR CONTACT TIME AND ATTENTION. THE USE OF MIXED METHODOLOGY ALSO PROVIDES THE OPPORTUNITY TO VALIDATE EXISTING KNOWLEDGE ABOUT YOGA AND HELPS TO EXPLORE NEW THEMES FOR FUTURE MINDFULNESS AND YOGA RESEARCH. 2014 3 2457 51 YOGA AS A COMPLEMENTARY TREATMENT FOR SMOKING CESSATION: RATIONALE, STUDY DESIGN AND PARTICIPANT CHARACTERISTICS OF THE QUITTING-IN-BALANCE STUDY. BACKGROUND: TOBACCO SMOKING REMAINS THE LEADING PREVENTABLE CAUSE OF DEATH AMONG AMERICAN WOMEN. EXERCISE HAS SHOWN PROMISE AS AN AID TO SMOKING CESSATION BECAUSE IT REDUCES WEIGHT GAIN AND WEIGHT CONCERNS, IMPROVES AFFECT, AND REDUCES NICOTINE WITHDRAWAL SYMPTOMS AND CIGARETTE CRAVING. STUDIES HAVE SHOWN THAT THE PRACTICE OF YOGA IMPROVES WEIGHT CONTROL, AND REDUCES PERCEIVED STRESS AND NEGATIVE AFFECT. YOGA PRACTICE ALSO INCLUDES REGULATION OF BREATHING AND FOCUSED ATTENTION, BOTH OF WHICH MAY ENHANCE STRESS REDUCTION AND IMPROVE MOOD AND WELL-BEING AND MAY IMPROVE CESSATION OUTCOMES. METHODS/DESIGN: THIS PILOT EFFICACY STUDY IS DESIGNED TO EXAMINE THE RATES OF CESSATION AMONG WOMEN RANDOMIZED TO EITHER A NOVEL, 8-WEEK YOGA PLUS COGNITIVE BEHAVIORAL THERAPY (CBT) SMOKING CESSATION INTERVENTION VERSUS A WELLNESS PROGRAM PLUS THE SAME CBT SMOKING CESSATION INTERVENTION. OUTCOME MEASURES INCLUDE 7-DAY POINT PREVALENCE ABSTINENCE AT END OF TREATMENT, 3 AND 6 MONTHS FOLLOW UP AND POTENTIAL MEDIATING VARIABLES (E.G., CONFIDENCE IN QUITTING SMOKING, SELF-EFFICACY). OTHER ASSESSMENTS INCLUDE MEASURES OF MINDFULNESS, SPIRITUALITY, DEPRESSIVE SYMPTOMS, ANXIETY AND PERCEIVED HEALTH (SF-36). DISCUSSION: INNOVATIVE TREATMENTS ARE NEEDED THAT ADDRESS BARRIERS TO SUCCESSFUL SMOKING CESSATION AMONG MEN AND WOMEN. THE DESIGN CHOSEN FOR THIS STUDY WILL ALLOW US TO EXPLORE POTENTIAL MEDIATORS OF INTERVENTION EFFICACY SO THAT WE MAY BETTER UNDERSTAND THE MECHANISM(S) BY WHICH YOGA MAY ACT AS AN EFFECTIVE COMPLEMENTARY TREATMENT FOR SMOKING CESSATION. IF SHOWN TO BE EFFECTIVE, YOGA CAN OFFER AN ALTERNATIVE TO TRADITIONAL EXERCISE FOR REDUCING NEGATIVE SYMPTOMS THAT OFTEN ACCOMPANY SMOKING CESSATION AND PREDICT RELAPSE TO SMOKING AMONG RECENT QUITTERS. TRIAL REGISTRATION: CLINICALTRIALS NCT00492310. 2010 4 1093 37 EFFECTS OF YOGA ON WELL-BEING AND HEALTHY AGEING: STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (FITFORAGE). INTRODUCTION: DUE TO AGEING POPULATIONS WORLDWIDE, THE BURDEN OF DISABILITY IS INCREASING. IT IS THEREFORE IMPORTANT TO DEVELOP INTERVENTIONS THAT IMPROVE HEALTHY AGEING, REDUCE DISABILITY ONSET AND ENHANCE LIFE QUALITY. PHYSICAL ACTIVITY CAN PROMOTE HEALTHY AGEING AND HELP MAINTAIN INDEPENDENCE, YET MANY OLDER ADULTS ARE INACTIVE. YOGA IS A FORM OF PHYSICAL ACTIVITY THAT AIMS TO IMPROVE HEALTH AND MAY BE PARTICULARLY SUITABLE FOR OLDER ADULTS. RESEARCH INDICATES POSITIVE EFFECTS OF YOGA ON SEVERAL HEALTH-RELATED OUTCOMES; HOWEVER, EMPIRICAL STUDIES EXAMINING THE BENEFITS OF YOGA ON WELL-BEING AMONG THE ELDERLY REMAIN SCARCE. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 12-WEEK YOGA PROGRAMME AIMED TO IMPROVE HEALTH AND WELL-BEING AMONG PHYSICALLY INACTIVE OLDER ADULTS. METHODS AND ANALYSIS: THREE GROUP PARALLEL, SINGLE-BLIND RANDOMISED CONTROLLED TRIAL. TWO COMPARISON GROUPS ARE INCLUDED: AEROBIC EXERCISE AND A NON-ACTIVE WAIT-LIST CONTROL. IN TOTAL, 180 PARTICIPANTS AGED 65-85 YEARS WILL BE RECRUITED. ASSESSMENTS WILL BE PERFORMED AT BASELINE AND POSTINTERVENTION (12-WEEK FOLLOW-UP). THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE PHYSICAL ACTIVITY/SEDENTARY BEHAVIOUR, MOBILITY/FALL RISK, COGNITION, DEPRESSION, ANXIETY, MOOD, STRESS, PAIN, SLEEP QUALITY, SOCIAL SUPPORT AND CARDIOMETABOLIC RISK FACTORS. DATA WILL BE ANALYSED USING INTENTION-TO-TREAT ANALYSES, WITH MIXED LINEAR MODELLING. ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE ETHICAL REVIEW BOARD IN STOCKHOLM (2017/1862-31/2). ALL PARTICIPANTS MUST VOLUNTARILY AGREE TO PARTICIPATE AND ARE FREE TO WITHDRAW FROM THE STUDY AT ANY POINT. WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. A SUMMARY OF KEY RESULTS WILL BE PUBLICLY AVAILABLE THROUGH NEWSPAPER ARTICLES. TRIAL REGISTRATION NUMBER: DRKS00015093, U1111-1217-4248. 2019 5 2843 29 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 6 258 35 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 7 627 35 DIFFERENCES BETWEEN MEN AND WOMEN ENROLLING IN SMOKING CESSATION PROGRAMS USING YOGA AS A COMPLEMENTARY THERAPY. THIS STUDY COMPARES THE CHARACTERISTICS OF MEN AND WOMEN, RESPECTIVELY, PARTICIPATING IN TWO RANDOMIZED CONTROLLED PILOT STUDIES WHOSE PRIMARY AIMS WERE TO TEST THE FEASIBILITY OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION. PARTICIPANTS WERE AGED 18-65, GENERALLY HEALTHY AND WERE DAILY SMOKERS. ANALYSIS OF VARIANCE (ANOVA) AND CHI-SQUARE TESTS EXAMINED GENDER DIFFERENCES IN SMOKING RATE, POTENTIAL TREATMENT MEDIATORS, AND COVARIATES (E.G., SMOKING HISTORY, HEALTH STATUS, WEIGHT CONCERNS, MOOD, AND PRIOR WITHDRAWAL SYMPTOMS). A TOTAL OF 55 WOMEN AND 38 MEN PARTICIPATED IN THE STUDY. DIFFERENCES BETWEEN MEN AND WOMEN AT ENROLLMENT INCLUDED: WOMEN REPORTED SIGNIFICANTLY GREATER WITHDRAWAL (P<0.005), ANXIETY (P=0.032), AND DEPRESSION (P=0.027) SYMPTOMS THAN MEN. MORE WOMEN THAN MEN (91% VS. 66%) REPORTED HAVING BEEN TOLD BY THEIR DOCTOR TO QUIT SMOKING (P=0.003), HAD AN EXISTING SMOKING-RELATED ILLNESS (33% VS. 13%; P=0.032), AND REPORTED SMOKING FOR WEIGHT CONTROL (15% VS. 0%; P=0.014). RESULTS SHOWED GOOD FEASIBILITY FOR RECRUITING BOTH MEN AND WOMEN INTO A STUDY USING YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION. RESULTS ALSO INDICATE THAT INTERVENTIONS MAY NEED TO BE TAILORED TO MEET DIFFERENT NEEDS (E.G., ADDRESSING CO-MORBID DEPRESSION) BETWEEN MEN AND WOMEN. 2016 8 2456 52 YOGA AS A COMPLEMENTARY TREATMENT FOR SMOKING CESSATION IN WOMEN. BACKGROUND: TOBACCO SMOKING REMAINS THE LEADING PREVENTABLE CAUSE OF DEATH AMONG AMERICAN WOMEN. AEROBIC EXERCISE HAS SHOWN PROMISE AS AN AID TO SMOKING CESSATION BECAUSE IT IMPROVES AFFECT AND REDUCES NICOTINE WITHDRAWAL SYMPTOMS. STUDIES OUTSIDE THE REALM OF SMOKING CESSATION HAVE SHOWN THAT YOGA PRACTICE ALSO REDUCES PERCEIVED STRESS AND NEGATIVE AFFECT. METHODS: THIS PILOT STUDY EXAMINES THE FEASIBILITY AND INITIAL EFFICACY OF YOGA AS A COMPLEMENTARY THERAPY FOR SMOKING CESSATION. FIFTY-FIVE WOMEN WERE GIVEN 8-WEEK GROUP-BASED COGNITIVE BEHAVIORAL THERAPY FOR SMOKING CESSATION AND WERE RANDOMIZED TO A TWICE-WEEKLY PROGRAM OF VINYASA YOGA OR A GENERAL HEALTH AND WELLNESS PROGRAM (CONTACT CONTROL). THE PRIMARY OUTCOME MEASURE WAS 7-DAY POINT PREVALENCE ABSTINENCE AT THE END OF TREATMENT VALIDATED BY SALIVA COTININE TESTING. LONGITUDINAL ANALYSES WERE ALSO CONDUCTED TO EXAMINE THE EFFECT OF INTERVENTION ON SMOKING CESSATION AT 3- AND 6-MONTH FOLLOW-UP. WE EXAMINED THE EFFECTS OF THE INTERVENTION ON POTENTIAL MEDIATING VARIABLES (E.G., CONFIDENCE IN QUITTING SMOKING, SELF-EFFICACY), AS WELL AS MEASURES OF DEPRESSIVE SYMPTOMS, ANXIETY, AND PERCEIVED HEALTH (SF-36). RESULTS: AT END OF TREATMENT, WOMEN IN THE YOGA GROUP HAD A GREATER 7-DAY POINT-PREVALENCE ABSTINENCE RATE THAN CONTROLS (ODDS RATIO [OR], 4.56; 95% CI, 1.1-18.6). ABSTINENCE REMAINED HIGHER AMONG YOGA PARTICIPANTS THROUGH THE SIX MONTH ASSESSMENT (OR, 1.54; 95% CI, 0.34-6.92), ALTHOUGH DIFFERENCES WERE NO LONGER STATISTICALLY SIGNIFICANT. WOMEN PARTICIPATING IN THE YOGA PROGRAM ALSO SHOWED REDUCED ANXIETY AND IMPROVEMENTS IN PERCEIVED HEALTH AND WELL-BEING WHEN COMPARED WITH CONTROLS. CONCLUSIONS: YOGA MAY BE AN EFFICACIOUS COMPLEMENTARY THERAPY FOR SMOKING CESSATION AMONG WOMEN. 2012 9 2638 38 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 10 1224 32 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 11 2046 40 THE ACUTE IMPACT OF HATHA YOGA ON CRAVING AMONG SMOKERS ATTEMPTING TO REDUCE OR QUIT. INTRODUCTION: DESPITE NEGATIVE EFFECTS OF SMOKING, SMOKERS HAVE DIFFICULTY QUITTING, SUGGESTING A NEED FOR ADDITIONAL STRATEGIES TO HELP THEM QUIT. A SINGLE-SESSION HATHA YOGA INTERVENTION ACUTELY REDUCED CRAVING AMONG NICOTINE-DEPRIVED SMOKERS NOT ATTEMPTING TO REDUCE OR QUIT, YET IT IS UNKNOWN IF IT REDUCES CRAVING AMONG THOSE ATTEMPTING TO CHANGE THEIR SMOKING. THUS, THIS STUDY TESTED THE EFFICACY OF A SINGLE-SESSION HATHA YOGA INTERVENTION FOR ACUTELY REDUCING CRAVING AMONG SMOKERS ATTEMPTING TO REDUCE OR QUIT SMOKING. METHODS: DATA PRESENTED ARE PART OF A LARGER DISSERTATION PROJECT. PARTICIPANTS WERE 55 COMMUNITY-RECRUITED SMOKERS (62% MALE) MOTIVATED TO REDUCE OR QUIT SMOKING RANDOMIZED TO ONE SESSION OF HATHA YOGA (N = 25) OR WELLNESS CONTROL (IE, READING EDUCATIONAL MATERIALS ABOUT HEALTHY LIFESTYLE; N = 30) ON THEIR INTERVENTION DAY (IE, THE DAY ON WHICH THEY BEGAN TO REDUCE OR QUIT SMOKING). PARTICIPANTS RATED, "I HAVE A DESIRE FOR A CIGARETTE RIGHT NOW," ON A 7-POINT LIKERT SCALE IMMEDIATELY BEFORE AND AFTER THE INTERVENTION. RESULTS: AFTER STATISTICALLY CONTROLLING FOR CO IN BREATH, PARTICIPANT TYPE, AGE, GENDER, RACE, AND ETHNICITY, A SIGNIFICANT TIME X CONDITION INTERACTION WAS FOUND, F(1, 47) = 4.72, P = .035, ETAP2 = .09, SUGGESTING CRAVING DECREASED AT A GREATER RATE IN THE HATHA YOGA CONDITION RELATIVE TO THE WELLNESS CONDITION. CONCLUSIONS: RESULTS FROM THIS STUDY ADD TO A GROWING BODY OF RESEARCH DEMONSTRATING THE POTENTIAL CLINICAL UTILITY OF HATHA YOGA AS AN ADJUNCTIVE INTERVENTION TOOL FOR SMOKING CESSATION. IMPLICATIONS: THIS IS THE FIRST KNOWN STUDY TO TEST THE IMPACT OF A SINGLE-SESSION HATHA YOGA INTERVENTION ON CRAVING AMONG ADULT SMOKERS ATTEMPTING TO REDUCE OR QUIT SMOKING. WE FOUND THAT 30 MINUTES OF HATHA YOGA PRODUCED A GREATER REDUCTION IN CRAVING COMPARED TO A 30-MINUTE WELLNESS CONTROL CONDITION. THIS RELATIONSHIP WAS EVIDENT EVEN AFTER STATISTICALLY ACCOUNTING FOR OTHER IMPORTANT VARIABLES (EG, GENDER). RESULTS OF THIS STUDY ADD TO A GROWING BODY OF LITERATURE DEMONSTRATING THE POTENTIAL CLINICAL UTILITY OF HATHA YOGA AS AN ADJUNCTIVE INTERVENTION STRATEGY FOR SMOKING CESSATION. 2020 12 478 31 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 13 122 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 14 265 37 ACUTE EFFECTS OF AEROBIC EXERCISE AND HATHA YOGA ON CRAVING TO SMOKE. INTRODUCTION: RECENT STUDIES HAVE EXAMINED THE EFFECTS OF PHYSICAL ACTIVITY ON CRAVING TO SMOKE AND SMOKING WITHDRAWAL. THE CURRENT STUDY WAS DESIGNED TO COMPARE AND CONTRAST THE EFFECTS OF 2 DIFFERENT FORMS OF PHYSICAL ACTIVITY ON GENERAL AND CUE-ELICITED CRAVING TO SMOKE. METHODS: FOLLOWING 1-HR NICOTINE ABSTINENCE, 76 DAILY SMOKERS WERE RANDOMLY ASSIGNED TO ENGAGE IN A 30-MIN BOUT OF CARDIOVASCULAR EXERCISE (CE; BRISK WALK ON A TREADMILL), HATHA YOGA (HY), OR A NONACTIVITY CONTROL CONDITION. PARTICIPANTS COMPLETED MEASURES OF CRAVING AND MOOD, AND A SMOKING CUE REACTIVITY ASSESSMENT, BEFORE, IMMEDIATELY FOLLOWING, AND APPROXIMATELY 20 MIN AFTER THE PHYSICAL ACTIVITY OR CONTROL CONDITIONS. RESULTS: COMPARED WITH THE CONTROL CONDITION, PARTICIPANTS IN EACH OF THE PHYSICAL ACTIVITY GROUPS REPORTED A DECREASE IN CRAVING TO SMOKE, AN INCREASE IN POSITIVE AFFECT, AND A DECREASE IN NEGATIVE AFFECT. IN ADDITION, CRAVING IN RESPONSE TO SMOKING CUES WAS SPECIFICALLY REDUCED AMONG THOSE WHO ENGAGED IN CE, WHEREAS THOSE WHO ENGAGED IN HY REPORTED A GENERAL DECREASE IN CRAVINGS. CONCLUSIONS: THIS STUDY PROVIDES FURTHER SUPPORT FOR THE USE OF EXERCISE BOUTS FOR ATTENUATING CIGARETTE CRAVINGS DURING TEMPORARY NICOTINE ABSTINENCE. RESULTS ALSO SUGGEST THAT CE CAN ATTENUATE CRAVINGS IN RESPONSE TO SMOKING CUES. THERE ARE SEVERAL AREAS FOR FURTHER RESEARCH THAT MAY IMPROVE INTEGRATION OF EXERCISE WITHIN SMOKING CESSATION TREATMENT. 2011 15 551 35 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS. 2018 16 2831 27 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 17 1235 32 FEASIBILITY AND SAFETY OF INTRADIALYSIS YOGA AND EDUCATION IN MAINTENANCE HEMODIALYSIS PATIENTS. OBJECTIVE: PATIENTS WITH END-STAGE RENAL DISEASE ON MAINTENANCE HEMODIALYSIS ARE MUCH MORE SEDENTARY THAN HEALTHY INDIVIDUALS. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE FEASIBILITY AND SAFETY OF A 12-WEEK INTRADIALYSIS YOGA INTERVENTION VERSUS A KIDNEY EDUCATION INTERVENTION ON THE PROMOTION OF PHYSICAL ACTIVITY. DESIGN AND METHODS: WE RANDOMIZED PARTICIPANTS BY DIALYSIS SHIFT TO EITHER 12-WEEK INTRADIALYSIS YOGA OR AN EDUCATIONAL INTERVENTION. INTRADIALYSIS YOGA WAS PROVIDED BY YOGA TEACHERS TO PARTICIPANTS WHILE RECEIVING HEMODIALYSIS. PARTICIPANTS RECEIVING THE 12-WEEK EDUCATIONAL INTERVENTION RECEIVED A MODIFICATION OF A PREVIOUSLY DEVELOPED COMPREHENSIVE EDUCATIONAL PROGRAM FOR PATIENTS WITH KIDNEY DISEASE (KIDNEY SCHOOL). THE PRIMARY OUTCOME FOR THIS STUDY WAS FEASIBILITY BASED ON RECRUITMENT AND ADHERENCE TO THE INTERVENTIONS AND SAFETY OF INTRADIALYSIS YOGA. SECONDARY OUTCOMES WERE TO DETERMINE THE FEASIBILITY OF ADMINISTERING QUESTIONNAIRES AT BASELINE AND 12 WEEKS INCLUDING THE KIDNEY DISEASE-RELATED QUALITY OF LIFE-36. RESULTS: AMONG 56 ELIGIBLE PATIENTS WHO APPROACHED FOR THE STUDY, 31 (55%) WERE INTERESTED AND CONSENTED TO PARTICIPATION, WITH 18 ASSIGNED TO INTRADIALYSIS YOGA AND 13 TO THE EDUCATIONAL PROGRAM. A TOTAL OF 5 PARTICIPANTS WITHDREW FROM THE PILOT STUDY, ALL FROM THE INTRADIALYSIS YOGA GROUP. TWO OF THESE PARTICIPANTS REPORTED NO FURTHER INTEREST IN PARTICIPATION. THREE WITHDRAWN PARTICIPANTS SWITCHED DIALYSIS TIMES AND THEREFORE COULD NO LONGER RECEIVE INTRADIALYSIS YOGA. AS A RESULT, 13 OF 18 (72%) AND 13 OF 13 (100%) PARTICIPANTS COMPLETED 12-WEEK INTRADIALYSIS YOGA AND EDUCATIONAL PROGRAMS, RESPECTIVELY. THERE WERE NO ADVERSE EVENTS RELATED TO INTRADIALYSIS YOGA. INTERVENTION PARTICIPANTS PRACTICED YOGA FOR A MEDIAN OF 21 SESSIONS (70% PARTICIPATION FREQUENCY), WITH 60% OF PARTICIPANTS PRACTICING AT LEAST 2 TIMES A WEEK. PARTICIPANTS IN THE EDUCATIONAL PROGRAM COMPLETED A MEDIAN OF 30 SESSIONS (83% PARTICIPATION FREQUENCY). OF PARTICIPANTS WHO COMPLETED THE STUDY (N = 26), BASELINE AND 12-WEEK QUESTIONNAIRES WERE OBTAINED FROM 85%. CONCLUSIONS: OUR PILOT STUDY OF 12-WEEK INTRADIALYSIS YOGA AND 12-WEEK EDUCATIONAL INTERVENTION REACHED RECRUITMENT GOALS BUT WITH LESS THAN TARGETED COMPLETION AND ADHERENCE TO INTERVENTION RATES. THIS STUDY PROVIDED VALUABLE FEASIBILITY DATA TO INCREASE FOLLOW-UP AND ADHERENCE FOR FUTURE CLINICAL TRIALS TO COMPARE EFFICACY. 2015 18 1215 36 EXPLORING THE EFFECTS OF YOGA THERAPY ON HEART RATE VARIABILITY AND PATIENT-REPORTED OUTCOMES AFTER CANCER TREATMENT: A STUDY PROTOCOL. BACKGROUND: FOLLOWING CANCER TREATMENT, ADULTS COMMONLY REPORT WORSENED PATIENT-REPORTED OUTCOMES (PROS) SUCH AS ANXIETY, STRESS, DEPRESSION, PERSISTENT AND UPSETTING COGNITIVE COMPLAINTS, UNRELENTING FATIGUE, AND REDUCED QUALITY OF LIFE. POORER PROS ARE ASSOCIATED WITH DISRUPTED AUTONOMIC NERVOUS SYSTEM FUNCTIONING AS MEASURED BY HEART RATE VARIABILITY (HRV), BOTH OF WHICH HAVE BEEN ASSOCIATED WITH GREATER MORBIDITY AND MORTALITY. INTERVENTIONS TO IMPROVE HRV AND PROS AMONG ADULTS FOLLOWING CANCER TREATMENT ARE NEEDED. YOGA THERAPY HOLDS PROMISE AS AN INTERVENTION TO IMPROVE HRV AND PROS. THEREFORE, WE CONDUCTED A SINGLE-SUBJECT EXPLORATORY EXPERIMENTAL STUDY TO INVESTIGATE THE EFFECTS OF YOGA THERAPY ON HRV AND SPECIFIC PROS (IE, CANCER-RELATED FATIGUE, ANXIETY, COGNITIVE FUNCTION, DEPRESSION, STRESS, QUALITY OF LIFE) IN ADULTS TREATED FOR CANCER. TO REDUCE PUBLICATION BIAS, IMPROVE REPRODUCIBILITY, AND SERVE AS A REFERENCE FOR FORTHCOMING REPORTING OF STUDY RESULTS, WE PRESENT THE STUDY PROTOCOL FOR THIS STUDY HEREIN. METHODS: PARTICIPANTS WERE ADULTS WHO COMPLETED CANCER TREATMENT THAT WERE RECRUITED FROM THE OTTAWA INTEGRATIVE CANCER CENTRE. CONSENTING AND ELIGIBLE PARTICIPANTS RECEIVED ONE 1:1 YOGA THERAPY SESSION (IE, 1 PARTICIPANT, 1 YOGA THERAPIST) AND 6 WEEKLY GROUP-BASED YOGA THERAPY SESSIONS (IE, 2-3 PARTICIPANTS, 1 YOGA THERAPIST). PARTICIPANTS COMPLETED ASSESSMENTS 7 TIMES: 3 TIMES PRIOR TO THE PROGRAM (IE, -6 WEEKS, -3 WEEKS, IMMEDIATELY PRIOR TO THE 1:1 YOGA THERAPY SESSION), IMMEDIATELY FOLLOWING THE 1:1 YOGA THERAPY SESSION, PRIOR TO THE FIRST GROUP-BASED YOGA THERAPY SESSION, AFTER THE LAST GROUP-BASED YOGA THERAPY SESSION, AND AT A 6-WEEK FOLLOW-UP. HIERARCHICAL LINEAR MODELING WILL BE USED TO TEST THE AVERAGE EFFECTS OF THE YOGA THERAPY PROGRAM ACROSS PARTICIPANTS. DISCUSSION: THIS STUDY WILL EXPLORE SEVERAL NOVEL HYPOTHESES, INCLUDING WHETHER YOGA THERAPY CAN IMPROVE HRV AND/OR SPECIFIC PROS AMONG ADULTS TREATED FOR CANCER ACUTELY (IE, DURING A 1:1 YOGA THERAPY SESSION) AND/OR THROUGH REPEATED EXPOSURE (IE, AFTER COMPLETING 6 WEEKS OF GROUP-BASED YOGA THERAPY). ALTHOUGH THE FINDINGS WILL REQUIRE CONFIRMATION OR REFUTATION IN FUTURE TRIALS, THEY MAY PROVIDE INITIAL EVIDENCE THAT YT MAY BENEFIT ADULTS TREATED FOR CANCER. TRIAL REGISTRATION: ISRCTN REGISTRY, ISRCTN64763228. REGISTERED ON DECEMBER 12, 2021. THIS TRIAL WAS REGISTERED RETROSPECTIVELY. URL OF TRIAL REGISTRY RECORD: HTTPS://WWW.ISRCTN.COM/ISRCTN64763228. 2022 19 888 44 EFFECT OF YOGA VERSUS LIGHT EXERCISE TO IMPROVE WELL-BEING AND PROMOTE HEALTHY AGING AMONG OLDER ADULTS IN CENTRAL INDIA: A STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: AGING IS A NATURAL PROCESS ASSOCIATED WITH MANY FUNCTIONAL AND STRUCTURAL CHANGES. THESE CHANGES MAY INCLUDE IMPAIRED SELF-REGULATION, CHANGES IN TISSUES AND ORGANS. AGING ALSO AFFECTS MOOD, PHYSICAL STATUS AND SOCIAL ACTIVITY. THERE ARE ADVERSE CHANGES IN COGNITIVE BEHAVIOR, PERCEIVED SENSATION AND THINKING PROCESSES. REGULAR PHYSICAL ACTIVITY CAN ALLEVIATE MANY HEALTH PROBLEMS; YET, MANY OLDER ADULTS ARE INACTIVE. YOGA IS ONE OF THE SCIENTIFIC AND POPULAR LIFESTYLE PRACTICE CONSIDERED AS THE INTEGRATION OF MIND, BODY AND SOUL. RESULTS OF PREVIOUS STUDIES REPORTED POSITIVE EFFECTS OF YOGA ON MULTIPLE HEALTH OUTCOMES IN ELDERLY. HOWEVER, THERE IS SCARCITY OF SCIENTIFIC INFORMATION WHERE YOGA'S EFFECT IS EXAMINED ON OVER WELL-BEING AND ON MULTIPLE HEALTH OUTCOMES SIMULTANEOUSLY IN ELDERLY. THIS PROTOCOL DESCRIBES METHODS FOR A 12-WEEK YOGA-BASED INTERVENTION EXPLORING THE EFFECTS OF YOGA ON WELL-BEING IN PHYSICALLY INACTIVE ELDERLY LIVING IN COMMUNITY. METHODS AND ANALYSIS: THIS TWO GROUP PARALLEL SINGLE BLIND RANDOMIZED CONTROLLED TRIAL THAT WILL BE CONDUCTED AT A DESIGNATED FACILITY OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, MADHYA PRADESH, CENTRAL INDIA. A 12-WEEK 60-MIN YOGA INTERVENTION THREE TIMES WEEKLY IS DESIGNED. COMPARISON GROUP PARTICIPANTS WILL UNDERGO A 60-MIN PROGRAM COMPRISING LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING TO IMPROVE MOBILITY. AFTER SCREENING, 144 PARTICIPANTS AGED 60-80 YEARS WILL BE RECRUITED. THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE MOBILITY, FALL RISK, COGNITION, ANXIETY AND DEPRESSION, MOOD AND STRESS, SLEEP QUALITY, PAIN, PHYSICAL ACTIVITY/SEDENTARY BEHAVIOR AND CARDIO-METABOLIC RISK FACTORS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE (0 WEEK), AFTER THE INTERVENTION (12+1 WEEK) AND AT FOLLOW-UP (36+1 WEEK). INTENTION-TO-TREAT ANALYSES WITH MIXED LINEAR MODELING WILL BE APPLIED. DISCUSSION: THROUGH THIS TRIAL, WE AIM TO DETERMINE WHETHER ELDERLY PEOPLE IN THE INTERVENTION GROUP PRACTICING YOGA SHOW MORE FAVORABLE PRIMARY (WELL-BEING) AND SECONDARY OUTCOMES THAN THOSE IN THE LIGHT EXERCISE FOCUSING ON CONVENTIONAL STRETCHING GROUP. WE ASSUME THAT YOGA MAY BE PRACTICED TO MAINTAIN HEALTH, REDUCE PARTICULAR SYMPTOMS COMMONLY ASSOCIATED WITH SKELETAL PAIN, ASSIST IN PAIN RELIEF AND ENHANCE WELL-BEING. WE ANTICIPATE THAT PRACTICING YOGA WILL IMPROVE WELL-BEING AND MENTAL HEALTH AND MAY LEAD TO SIGNIFICANT IMPROVEMENT IN DEPRESSION, PAIN AND SLEEP QUALITY.ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF R.D. GARDI MEDICAL COLLEGE, UJJAIN, IEC REF NO. 09/2018. ALL PARTICIPANTS WOULD BE PROVIDED WITH WRITTEN AND VERBAL INFORMATION ABOUT THE PURPOSE OF THE PROJECT AND WOULD BE FREE TO WITHDRAW FROM THE STUDY AT ANY TIME. REFUSAL TO PARTICIPATE IN THE STUDY WOULD NOT HAVE ANY NEGATIVE CONSEQUENCES. CONFIDENTIALITY OF THE INFORMATION OF EACH PARTICIPANT WOULD BE ENSURED. KNOWLEDGE OBTAINED WOULD BE DISSEMINATED TO STAKEHOLDERS THROUGH WORKSHOPS, MEETINGS AND RELEVANT SCIENTIFIC CONFERENCES. TRIAL REGISTRATION: THE TRIAL IS PROSPECTIVELY REGISTERED WITH THE INDIAN COUNCIL OF MEDICAL RESEARCH TRIAL REGISTRY CTRI/2018/07/015051. 2019 20 2628 36 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