1 1149 166 ENHANCEMENT OF CANCER STEM CELL SUSCEPTIBILITY TO CONVENTIONAL TREATMENTS THROUGH COMPLEMENTARY YOGA THERAPY: POSSIBLE CELLULAR AND MOLECULAR MECHANISMS. CANCER STEM CELLS (CSCS) ARE STEM-LIKE TUMOR POPULATIONS THAT ARE REPORTED TO CONTRIBUTE TOWARDS TUMOR GROWTH, MAINTENANCE AND RECURRENCE AFTER THERAPY. HYPOXIA INCREASES CSC FRACTION AND PROMOTES ACQUISITION OF A STEM-CELL-LIKE STATE. CANCER STEM CELLS ARE CRITICALLY DEPENDANT ON THE HYPOXIA-INDUCIBLE FACTOR-1 (HIF-1) FOR SURVIVAL, SELF-RENEWAL, TUMOR GROWTH AND MAINTENANCE OF THEIR UNDIFFERENTIATED PHENOTYPE. RECENT RESEARCHES SHOW THAT STAGE OF DIFFERENTIATION OF THE TUMOR CELLS IS PREDICTIVE OF THEIR SUSCEPTIBILITY TO NATURAL KILLER CELL (NK) CELL MEDIATED CYTOTOXICITY AND CANCER STEM CELLS ARE SIGNIFICANT TARGETS OF NK CELL CYTOTOXICITY. STUDIES ALSO SHOW THAT REVERSION OF TUMOR CELLS TO A LESS-DIFFERENTIATED PHENOTYPE CAN BE ACHIEVED BY BLOCKING NFKAPPAB. YOGA THERAPY (YOGIC LIFESTYLE MODIFICATIONS ENCOMPASSING PHYSICAL POSTURES, BREATHING PRACTICES, RELAXATION TECHNIQUES AND MEDITATIONS) IS KNOWN TO MODULATE NEURAL, ENDOCRINE AND IMMUNE FUNCTIONS AT THE CELLULAR LEVEL THROUGH INFLUENCING CELL CYCLE CONTROL, AGING, OXIDATIVE STRESS, APOPTOSIS AND SEVERAL PATHWAYS OF STRESS SIGNALING MOLECULES. YOGA THERAPY HAS ALSO BEEN SHOWN TO ENHANCE NATURAL KILLER CELL ACTIVITY AND MODULATE STRESS AND DNA DAMAGE IN BREAST CANCER PATIENTS RECEIVING RADIOTHERAPY. RECENT STUDY FOUND THAT BRIEF DAILY YOGIC MEDITATION MAY REVERSE THE PATTERN OF INCREASED NFKAPPAB-RELATED TRANSCRIPTION OF PRO-INFLAMMATORY CYTOKINES IN LEUKOCYTES. THUS, YOGA THERAPY HAS THE POTENTIAL TO REDUCE CANCER STEM CELL SURVIVAL, SELF -RENEWAL AND TUMOR GROWTH BY MODIFYING THE TUMOR MICRO-ENVIRONMENT THROUGH VARIOUS MECHANISMS SUCH AS; 1) REDUCING HIF-1 ACTIVITY BY ENHANCED OXYGENATION, 2) PROMOTING NK CELL ACTIVITY DIRECTLY (OR INDIRECTLY THROUGH DOWN REGULATING NFKAPPAB EXPRESSION), THEREBY ENHANCING NK CELL MEDIATED CSC LYSIS, AND 3) BY MINIMIZING THE ABERRANT EXPRESSIONS OR ACTIVITIES OF VARIOUS HORMONES, CYTOKINES, CHEMOKINES AND TUMOR SIGNALING PATHWAYS. YOGA THERAPY MAY HAVE A SYNERGISTIC EFFECT WITH CONVENTIONAL MODALITIES OF TREATMENT IN PREVENTING CANCER PROGRESSION AND RECURRENCES. 2012 2 2008 26 STUDY PROTOCOL FOR YOGA-BASED LIFESTYLE INTERVENTION FOR HEALTHY AGEING PHENOTYPE IN THE OLDER ADULTS (YHAP): A TWO-ARMED, WAITLIST RANDOMISED CONTROLLED TRIAL WITH MULTIPLE PRIMARY OUTCOMES. INTRODUCTION: THE CONCEPTUALISATION OF HEALTHY AGEING PHENOTYPE (HAP) AND THE AVAILABILITY OF A TENTATIVE PANEL FOR HAP BIOMARKERS RAISE THE NEED TO TEST THE EFFICACY OF POTENTIAL INTERVENTIONS TO PROMOTE HEALTH IN OLDER ADULTS. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 24-WEEK PROGRAMME TO EXPLORE THE HOLISTIC INFLUENCE OF THE YOGA-BASED INTERVENTION ON THE (BIO)MARKERS OF HAP. METHODS AND ANALYSIS: THE STUDY IS A TWO-ARMED, RANDOMISED WAITLIST CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS AND MULTIPLE PRIMARY OUTCOMES. WE AIM TO RECRUIT 250 SUBJECTS, AGED 60-80 YEARS FROM THE RESIDENTIAL COMMUNITIES AND OLD AGE CLUBS IN BANGALORE CITY, INDIA, WHO WILL UNDERGO RANDOMISATION INTO INTERVENTION OR CONTROL ARMS (1:1). THE INTERVENTION WILL INCLUDE A YOGA-BASED PROGRAMME TAILORED FOR THE OLDER ADULTS, 1 HOUR PER DAY FOR 6 DAYS A WEEK, SPREAD FOR 24 WEEKS. DATA WOULD BE COLLECTED AT THE BASELINE AND POST-INTERVENTION, THE 24TH WEEK. THE MULTIPLE PRIMARY OUTCOMES OF THE STUDY ARE THE (BIO)MARKERS OF HAP: GLYCATED HAEMOGLOBIN, LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C), SYSTOLIC BLOOD PRESSURE, AND FORCED EXPIRATORY VOLUME IN 1 S FOR PHYSIOLOGICAL AND METABOLIC HEALTH; DIGIT SYMBOL SUBSTITUTION TEST, TRAIL MAKING TESTS A AND B FOR COGNITION; HAND GRIP STRENGTH AND GAIT SPEED FOR PHYSICAL CAPABILITY; LONELINESS FOR SOCIAL WELL-BEING AND WHO QUALITY OF LIFE INSTRUMENT-SHORT FORM FOR QUALITY OF LIFE. THE SECONDARY OUTCOMES INCLUDE INFLAMMATORY MARKERS, TUMOUR NECROSIS FACTOR-ALPHA RECEPTOR II, C REACTIVE PROTEIN, INTERLEUKIN 6 AND SERUM KLOTHO LEVELS. ANALYSES WILL BE BY INTENTION-TO-TREAT AND THE HOLISTIC IMPACT OF YOGA ON HAP WILL BE ASSESSED USING GLOBAL STATISTICAL TEST. ETHICS AND DISSEMINATION: THE STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA UNIVERSITY, BANGALORE (ID: RES/IEC-SVYASA/143/2019). WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373. 2021 3 1375 30 IMPACT OF DAILY YOGA-BASED EXERCISE ON PAIN, CATASTROPHIZING, AND SLEEP AMONGST INDIVIDUALS WITH FIBROMYALGIA. BACKGROUND: FIBROMYALGIA (FM) IS A CHRONIC WIDESPREAD PAIN DISORDER CHARACTERIZED BY NEGATIVE AFFECT, SLEEP DISTURBANCE, AND FATIGUE. THIS UNCONTROLLED PILOT STUDY INVESTIGATED THE EFFICACY OF DAILY YOGA-BASED EXERCISE TO IMPROVE FM SYMPTOMS AND EXPLORED BASELINE PHENOTYPIC CHARACTERISTICS ASSOCIATED WITH THE GREATEST BENEFIT. METHODS: FM PATIENTS (N=46, WITH 36 COMPLETERS) REPORTED PSYCHOSOCIAL FUNCTIONING AND A RANGE OF FM SYMPTOMS USING VALIDATED INSTRUMENTS BEFORE AND AFTER PARTICIPATION IN SATYANANDA YOGA, WHICH INCLUDED WEEKLY IN-PERSON PAIN-TAILORED GROUP CLASSES FOR 6 WEEKS AND DAILY HOME YOGA VIDEO PRACTICE. RESULTS: CHANGES IN FM SYMPTOMS FROM PRE- TO POST-YOGA WERE VARIABLE AMONGST PARTICIPANTS. GROUP MEANS FOR PAIN DECREASED, AS REPORTED BY AVERAGE DAILY DIARY AND BRIEF PAIN INVENTORY, WITH GREATER HOME PRACTICE MINUTES ASSOCIATED WITH A GREATER DECREASE IN PAIN. AVERAGE DAILY RATINGS OF SLEEP AND FATIGUE IMPROVED. PAIN CATASTROPHIZING WAS DECREASED OVERALL, WITH GREATER CHANGE CORRELATED TO A DECREASE IN FM SYMPTOMS. WE DID NOT OBSERVE ANY GROUP MEAN CHANGES IN ACTIGRAPHY SLEEP EFFICIENCY, PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-ANXIETY AND THE REVISED FIBROMYALGIA IMPACT QUESTIONNAIRE. MULTILEVEL MODELING ANALYSIS REVEALED A SIGNIFICANT INTERACTION BETWEEN ANXIETY AND CATASTROPHIZING FOR END-STUDY SLEEP EFFICIENCY, FATIGUE, AND PAIN, SUCH THAT PATIENTS WITH HIGHER BASELINE CATASTROPHIZING AND LOWER BASELINE ANXIETY REPORTED LESS PAIN AND FATIGUE, AND HIGHER SLEEP EFFICIENCY AFTER THE SIXTH WEEK OF YOGA PRACTICE. CONCLUSION: THIS PILOT STUDY SUGGESTS THAT YOGA MAY REDUCE PAIN AND CATASTROPHIZING, AS WELL AS IMPROVE SLEEP, BUT THESE CHANGES WERE MODEST ACROSS STUDY PARTICIPANTS. GREATER UPTAKE OF HOME YOGA PRACTICE AS WELL AS A PHENOTYPE OF HIGHER BASELINE CATASTROPHIZING COMBINED WITH LOWER BASELINE ANXIETY WERE ASSOCIATED WITH GREATER IMPACT. FUTURE RANDOMIZED, CONTROLLED TRIALS COMPARING DIFFERENT TYPES OF YOGA OR EXERCISE WILL ALLOW DETERMINATION OF THE MOST EFFECTIVE TREATMENTS FOR FM AND ALLOW CLOSER TARGETING TO THE PATIENTS WHO WILL BENEFIT MOST FROM THEM. 2019 4 258 26 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 5 1093 30 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 6 1347 46 HYPOXIA IN CNS PATHOLOGIES: EMERGING ROLE OF MIRNA-BASED NEUROTHERAPEUTICS AND YOGA BASED ALTERNATIVE THERAPIES. CELLULAR RESPIRATION IS A VITAL PROCESS FOR THE EXISTENCE OF LIFE. ANY CONDITION THAT RESULTS IN DEPRIVATION OF OXYGEN (ALSO TERMED AS HYPOXIA) MAY EVENTUALLY LEAD TO DELETERIOUS EFFECTS ON THE FUNCTIONING OF TISSUES. BRAIN BEING THE HIGHEST CONSUMER OF OXYGEN IS PRONE TO INCREASED RISK OF HYPOXIA-INDUCED NEUROLOGICAL INSULTS. THIS IN TURN HAS BEEN ASSOCIATED WITH MANY DISEASES OF CENTRAL NERVOUS SYSTEM (CNS) SUCH AS STROKE, ALZHEIMER'S, ENCEPHALOPATHY ETC. ALTHOUGH SEVERAL STUDIES HAVE INVESTIGATED THE PATHOPHYSIOLOGICAL MECHANISMS UNDERLYING ISCHEMIC/HYPOXIC CNS DISEASES, THE KNOWLEDGE ABOUT PROTECTIVE THERAPEUTIC STRATEGIES TO AMELIORATE THE AFFECTED NEURONAL CELLS IS MEAGER. THIS HAS AUGMENTED THE NEED TO IMPROVE OUR UNDERSTANDING OF THE HYPOXIC AND ISCHEMIC EVENTS OCCURRING IN THE BRAIN AND IDENTIFY NOVEL AND ALTERNATE TREATMENT MODALITIES FOR SUCH INSULTS. MICRORNA (MIRNAS), SMALL NON-CODING RNA MOLECULES, HAVE RECENTLY EMERGED AS POTENTIAL NEUROPROTECTIVE AGENTS AS WELL AS TARGETS, UNDER HYPOXIC CONDITIONS. THESE 18-22 NUCLEOTIDE LONG RNA MOLECULES ARE PROFUSELY PRESENT IN BRAIN AND OTHER ORGANS AND FUNCTION AS GENE REGULATORS BY CLEAVING AND SILENCING THE GENE EXPRESSION. IN BRAIN, THESE ARE KNOWN TO BE INVOLVED IN NEURONAL DIFFERENTIATION AND PLASTICITY. THEREFORE, TARGETING MIRNA EXPRESSION REPRESENTS A NOVEL THERAPEUTIC APPROACH TO INTERCEDE AGAINST HYPOXIC AND ISCHEMIC BRAIN INJURY. IN THE FIRST PART OF THIS REVIEW, WE WILL DISCUSS THE NEUROPHYSIOLOGICAL CHANGES CAUSED AS A RESULT OF HYPOXIA, FOLLOWED BY THE CONTRIBUTION OF HYPOXIA IN THE NEURODEGENERATIVE DISEASES. SECONDLY, WE WILL PROVIDE RECENT UPDATES AND INSIGHTS INTO THE ROLES OF MIRNA IN THE REGULATION OF GENES IN OXYGEN AND GLUCOSE DEPRIVED BRAIN IN ASSOCIATION WITH CIRCADIAN RHYTHMS AND HOW THESE CAN BE TARGETED AS NEUROPROTECTIVE AGENTS FOR CNS INJURIES. FINALLY, WE WILL EMPHASIZE ON ALTERNATE BREATHING OR YOGIC INTERVENTIONS TO OVERCOME THE HYPOXIA ASSOCIATED ANOMALIES THAT COULD ULTIMATELY LEAD TO IMPROVEMENT IN CEREBRAL PERFUSION. 2017 7 2843 25 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 8 1789 28 PRELIMINARY INDICATIONS OF THE EFFECT OF A BRIEF YOGA INTERVENTION ON MARKERS OF INFLAMMATION AND DNA METHYLATION IN CHRONICALLY STRESSED WOMEN. YOGA IS ASSOCIATED WITH REDUCED STRESS AND INCREASED WELL-BEING, ALTHOUGH THE MOLECULAR BASIS FOR THESE BENEFITS IS NOT CLEAR. MOUNTING EVIDENCE IMPLICATES THE IMMUNE RESPONSE, WITH CURRENT STUDIES FOCUSED ON PROTEIN IMMUNE MARKERS (SUCH AS CYTOKINES) IN CLINICAL POPULATIONS. TO EXPLORE THE MOLECULAR IMPACT, THIS PILOT STUDY USES A SUBSAMPLE (N=28) FROM A RANDOMISED WAITLIST CONTROL TRIAL INVESTIGATING THE IMPACT OF AN 8-WEEK YOGA INTERVENTION IN A COMMUNITY POPULATION OF WOMEN REPORTING PSYCHOLOGICAL DISTRESS (N=116). WE MEASURED INTERLEUKIN-6 (IL-6), TUMOUR NECROSIS FACTOR (TNF) AND C-REACTIVE PROTEIN (CRP) PROTEIN LEVELS, AND THE DNA METHYLATION OF THESE GENES AND THE GLOBAL INDICATOR, LINE-1. CORRELATIONS BETWEEN THESE AND PSYCHOLOGICAL VARIABLES WERE EXPLORED, IDENTIFYING MODERATE CORRELATIONS WITH CRP PROTEIN LEVELS, AND METHYLATION OF IL-6, CRP AND LINE-1. MANY CYTOKINE SAMPLES WERE BELOW DETECTION, HOWEVER A MANN-WHITNEY U DEMONSTRATED A TREND OF MODERATE BETWEEN-GROUP EFFECT FOR ELEVATED IL-6 IN THE YOGA GROUP. METHYLATION ANALYSES APPLIED CROSS-SECTIONAL AND NON-CONTROLLED LONGITUDINAL ANALYSES. WAIST-TO-HEIGHT RATIO AND AGE WERE COVARIED. WE DEMONSTRATED REDUCED METHYLATION OF THE TNF REGION IN THE YOGA GROUP RELATIVE TO THE WAITLIST CONTROL GROUP. NO OTHER GENES DEMONSTRATED A SIGNIFICANT DIFFERENCE. LONGITUDINAL ANALYSIS FURTHER SUPPORTED THESE RESULTS. THIS STUDY IS ONE OF THE FIRST TO EXPLORE YOGA AND IMMUNOLOGICAL MARKERS IN A NON-CLINICAL POPULATION, AND IS THE FIRST STUDY TO EXPLORE DNA METHYLATION. THESE FINDINGS INDICATE THAT FURTHER RESEARCH INTO MOLECULAR IMPACT OF YOGA ON MARKERS OF IMMUNE FUNCTION IS WARRANTED, WITH LARGER STUDIES REQUIRED. 2016 9 508 19 COMPARATIVE EFFICACY OF A 12 WEEK YOGA-BASED LIFESTYLE INTERVENTION AND DIETARY INTERVENTION ON ADIPOKINES, INFLAMMATION, AND OXIDATIVE STRESS IN ADULTS WITH METABOLIC SYNDROME: A RANDOMIZED CONTROLLED TRIAL. THE PRESENT RANDOMIZED CONTROLLED TRIAL (RCT) EVALUATED THE COMPARATIVE EFFICACY OF 12 WEEK YOGA-BASED LIFESTYLE INTERVENTION (YBLI) AND DIETARY INTERVENTION (DI) ALONE ON ADIPOKINES, INFLAMMATION, AND OXIDATIVE STRESS IN INDIAN ADULTS WITH METABOLIC SYNDROME (MET S). A PARALLEL, TWO ARM, RCT WAS CONDUCTED IN INTEGRAL HEALTH CLINIC (IHC), ALL INDIA INSTITUTE OF MEDICAL SCIENCES, INDIA FROM 2012 TO 2014. IHC IS AN OUTPATIENT FACILITY CONDUCTING YBLI PROGRAMS FOR PREVENTION AND MANAGEMENT OF CHRONIC DISEASES. TWO HUNDRED SIXTY MEN AND WOMEN (20-45 YEARS) VISITING THE OUTPATIENT DEPARTMENT OF A TERTIARY CARE HOSPITAL WERE DIAGNOSED WITH MET S AND RANDOMIZED 1:1 TO RECEIVE 12 WEEK YBLI (N = 130) OR DI (N = 130). PRIMARY OUTCOMES WERE CHANGE IN PLASMA LEVELS OF ADIPOKINES (LEPTIN, ADIPONECTIN, AND LEPTIN:ADIPONECTIN RATIO), MARKERS OF INFLAMMATION (TUMOR NECROSIS FACTOR [TNF]-ALPHA, INTERLEUKIN [IL]-6), MARKERS OF OXIDATIVE STRESS (THIOBARBITURIC ACID REACTIVE SUBSTANCES [TBARS], 8-HYDROXY-2'-DEOXYGUANOSINE [8-OHDG], AND SUPEROXIDE DISMUTASE [SOD]) MEASURED AT BASELINE, 2 WEEKS, AND 12 WEEKS. YBLI GROUP SHOWED A SIGNIFICANT DECREASE IN LEPTIN, LEPTIN:ADIPONECTIN RATIO, IL-6, 8-OHDG, AND TBARS LEVELS, WHEREAS THERE WAS A SIGNIFICANT INCREASE IN ADIPONECTIN AND SOD LEVELS. NO SIGNIFICANT CHANGES WERE NOTICED IN DI ALONE GROUP. YBLI SHOWED SIGNIFICANTLY GREATER REDUCTION IN TBARS LEVELS THAN IN DI GROUP, SUGGESTIVE OF REDUCED OXIDATIVE STRESS IN ADULTS WITH MET S. A 12 WEEK YBLI HAD A POSITIVE IMPACT ON OXIDATIVE STRESS VERSUS DI ALONE IN ADULTS WITH MET S. 2019 10 2412 30 YOGA AND ITS IMPACT ON CHRONIC INFLAMMATORY AUTOIMMUNE ARTHRITIS. RHEUMATOID ARTHRITIS (RA) IS ONE OF THE MOST COMMON CHRONIC INFLAMMATORY AUTOIMMUNE DISEASES, WHICH ADVERSELY AFFECTS THE QUALITY OF LIFE. RA IS A DISEASE OF UNKNOWN ETIOLOGY, HOWEVER, BOTH GENETIC AND ENVIRONMENTAL FACTORS APPEAR TO CONTRIBUTE TO THE SUSCEPTIBILITY TO THIS DISEASE. THE SEVERITY AND PROGRESSION OF THE DISEASE ARE ATTRIBUTABLE TO THE RELEASE OF A HOST OF INFLAMMATORY CYTOKINES, CYTOTOXIC AND IMMUNE REGULATORY FACTORS. THE TREATMENTS OF RA ARE PRIMARILY LIMITED TO SYMPTOMATIC ALLEVIATION OF PAIN OR OTHER SYMPTOMS OR TO THE USE OF CYTOTOXIC DRUG TREATMENT IN SEVERE FORMS OF THE DISEASE WHICH IS COMMONLY ASSOCIATED WITH SIGNIFICANT SIDE EFFECTS. DESPITE LACK OF A CURE, THE DISEASE MAY BE CONTROLLED BY MIND-BODY INTERVENTIONS. HOLISTIC TREATMENTS SUCH AS YOGA SIGNIFICANTLY IMPROVE AND REDUCE THE PSYCHO-SOMATIC SYMPTOMS, PAIN PERCEPTION, DISABILITY QUOTIENT, JOINT FLEXIBILITY, RANGE OF MOTION, POSTURE, MUSCLE STRENGTH, COORDINATION, AND DISEASE ACTIVITY. HERE, WE DISCUSS THE FEATURES OF RA AND ADDRESS HOW YOGA CAN BE USED AS A THERAPEUTIC REGIMEN TO IMPROVE THE QUALITY OF LIFE OF PATIENTS WITH RA. 2021 11 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 12 2038 40 TELOMERASE ACTIVITY AND CELLULAR AGING MIGHT BE POSITIVELY MODIFIED BY A YOGA-BASED LIFESTYLE INTERVENTION. OBJECTIVES: RECENT STUDIES SHOWED THAT A BRIEF YOGA-BASED LIFESTYLE INTERVENTION WAS EFFICACIOUS IN REDUCING LEVELS OF OXIDATIVE STRESS AND CELLULAR AGING IN OBESE MEN. THE OBJECTIVE OF THIS CASE REPORT WAS TO ASSESS THE EFFICACY OF THIS INTERVENTION IN REDUCING THE LEVELS OF BIOCHEMICAL MARKERS OF CELLULAR AGEING, OXIDATIVE STRESS, AND INFLAMMATION AT BASELINE (DAY 0), AT THE END OF ACTIVE INTERVENTION (DAY 10), AND FOLLOW-UP AT DAY 90. DESIGN: SINGLE CASE REPORT FROM A PROSPECTIVE ONGOING STUDY WITH PRE-POST DESIGN ASSESSING THE LEVEL OF VARIOUS MARKERS OF CELLULAR AGING. SETTING: INTEGRAL HEALTH CLINIC, AN OUTPATIENT FACILITY CONDUCTING MEDITATION AND YOGA-BASED LIFESTYLE INTERVENTION PROGRAMS FOR MANAGEMENT OF CHRONIC DISEASES. PATIENT: A 31-YEAR-OLD MAN WITH CLASS I OBESITY (BODY-MASS INDEX, 29.5 KG/M(2)) WHO PRESENTED TO THE MEDICINE OUTPATIENT DEPARTMENT AT ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA, WITH A HISTORY OF FATIGUE, DIFFICULTY LOSING WEIGHT, AND LACK OF MOTIVATION. HE NOTED A MARKED DECREASE IN HIS ENERGY LEVEL, PARTICULARLY IN THE AFTERNOON. INTERVENTION: A PRETESTED INTERVENTION PROGRAM INCLUDED ASANAS (POSTURES), PRANAYAMA (BREATHING EXERCISES), STRESS MANAGEMENT, GROUP DISCUSSIONS, LECTURES, AND INDIVIDUALIZED ADVICE. RESULTS: FROM BASELINE (DAY 0) TO DAY 90, THE ACTIVITY OF TELOMERASE AND LEVELS OF BETA-ENDORPHINS, PLASMA CORTISOL, AND INTERLEUKIN-6 INCREASED, AND A SUSTAINED REDUCTION IN OXIDATIVE STRESS MARKERS, SUCH AS REACTIVE OXYGEN SPECIES AND 8-HYDROXY-2-DEOXY-GUANOSINE LEVELS. CONCLUSIONS: ADOPTING YOGA/MEDITATION-BASED LIFESTYLE MODIFICATION CAUSES REVERSAL OF MARKERS OF AGING, MAINLY OXIDATIVE STRESS, TELOMERASE ACTIVITY, AND OXIDATIVE DNA DAMAGE. THIS MAY NOT ONLY DELAY AGING AND PROLONG A YOUTHFUL HEALTHY LIFE BUT ALSO DELAY OR PREVENT ONSET OF SEVERAL LIFESTYLE-RELATED DISEASES, OF WHICH OXIDATIVE STRESS AND INFLAMMATION ARE THE CHIEF CAUSE. THIS REPORT SUGGESTS THIS SIMPLE LIFESTYLE INTERVENTION MAY BE THERAPEUTIC FOR OXIDATIVE DNA DAMAGE AND OXIDATIVE STRESS. 2015 13 683 39 EFFECT OF AN 8-WEEK YOGA-BASED LIFESTYLE INTERVENTION ON PSYCHO-NEURO-IMMUNE AXIS, DISEASE ACTIVITY, AND PERCEIVED QUALITY OF LIFE IN RHEUMATOID ARTHRITIS PATIENTS: A RANDOMIZED CONTROLLED TRIAL. VARIOUS EXTERNAL STRESSORS AND ENVIRONMENTAL CHALLENGES LEAD TO THE PROVOCATION OF THE IMMUNE SYSTEM IN AUTOIMMUNE DISEASES LIKE RHEUMATOID ARTHRITIS (RA). THE INAPPROPRIATE IMMUNE RESPONSE FURTHER TRIGGERS THE CASCADE OF INFLAMMATORY CHANGES RESULTING IN PRECIPITATION OF SYMPTOMS AND HAMPERS QUALITY OF LIFE (QOL). THE UNDERLYING PSYCHO-SOMATIC COMPONENT OF THE DISEASE REQUIRES A HOLISTIC APPROACH TO ITS TREATMENT DIMENSION RATHER THAN THE USE OF PHARMACOTHERAPY. THE APPLICABILITY OF MIND-BODY INTERVENTIONS HAS BECOME ESSENTIAL IN TODAY'S FAST-PACED LIFE. YOGA, A MIND-BODY TECHNIQUE, ALTERS THE MIND'S CAPACITY TO FACILITATE SYSTEMIC FUNCTIONING AT MULTIPLE ORGAN SYSTEM LEVELS. HENCE, WE CONDUCTED THIS STUDY TO EVALUATE THE IMPACT OF 8 WEEKS OF A YOGA-BASED LIFESTYLE INTERVENTION (YBLI) ON PSYCHO-NEURO-IMMUNE MARKERS, GENE EXPRESSION PATTERNS, AND QOL IN RA PATIENTS ON ROUTINE MEDICAL THERAPY. A TOTAL OF 66 PATIENTS WERE RANDOMIZED INTO TWO GROUPS: YOGA GROUP OR NON-YOGA GROUP AND WERE ASSESSED FOR A PANEL OF INFLAMMATORY CYTOKINES (IL-6, IL-17A, TNF-ALPHA, AND TGF-BETA), MIND-BODY COMMUNICATIVE MARKERS (BDNF, DHEAS, BETA-ENDORPHIN, AND SIRTUIN) AND TRANSCRIPT LEVELS OF VARIOUS GENES (IL-6, TNF-ALPHA, NFKB1, TGF-BETA, AND CTLA4). WE ASSESSED DISEASE ACTIVITY AND QOL USING THE DAS28-ESR AND WHOQOL-BREF QUESTIONNAIRE, RESPECTIVELY. YOGA GROUP OBSERVED SIGNIFICANT IMPROVEMENTS IN THE LEVELS OF MARKERS, WHICH INFLUENCED THE PSYCHO-NEURO-IMMUNE AXIS (P < 0.001) WITH AN ESTIMATED EFFECT SIZE FROM SMALL TO MEDIUM RANGE. IN THE YOGA GROUP, THERE WAS A SIGNIFICANT REDUCTION IN DAS28-ESR (P < 0.001) AND IMPROVEMENT SEEN IN THE PHYSICAL HEALTH, PSYCHOLOGICAL, SOCIAL RELATIONSHIPS DOMAINS (P < 0.001) OF QOL, EXCEPT ENVIRONMENTAL (P > 0.05). THE YOGA GROUP SHOWED DOWNREGULATION OF IL-6, TNF-ALPHA, AND CTLA4 AND UPREGULATION OF TGF-BETA. THESE RESULTS SUGGEST THAT A DECREASE IN DISEASE ACTIVITY AFTER YOGA PRACTICE IS ASSOCIATED WITH A SIGNIFICANT REDUCTION IN INFLAMMATORY CYTOKINES, THE ELEVATION OF MIND-BODY COMMUNICATIVE MARKERS, AND NORMALIZATION OF VARIOUS TRANSCRIPT LEVELS, WHICH IMPROVED QOL. THUS THE ADOPTION OF YBLI IMPROVES CLINICAL OUTCOME IN RA, AND DECREASES SYSTEMIC INFLAMMATION BY ITS BENEFICIAL EFFECTS ON PSYCHO-NEURO-IMMUNE AXIS AND NORMALIZATION OF DYSREGULATED TRANSCRIPTS. THUS YBLI MAY BE USED FOR RA PATIENTS AS AN ADJUNCTIVE THERAPY. 2020 14 2847 35 YOGA, MEDITATION AND MIND-BODY HEALTH: INCREASED BDNF, CORTISOL AWAKENING RESPONSE, AND ALTERED INFLAMMATORY MARKER EXPRESSION AFTER A 3-MONTH YOGA AND MEDITATION RETREAT. THIRTY-EIGHT INDIVIDUALS (MEAN AGE: 34.8 YEARS OLD) PARTICIPATING IN A 3-MONTH YOGA AND MEDITATION RETREAT WERE ASSESSED BEFORE AND AFTER THE INTERVENTION FOR PSYCHOMETRIC MEASURES, BRAIN DERIVED NEUROTROPHIC FACTOR (BDNF), CIRCADIAN SALIVARY CORTISOL LEVELS, AND PRO- AND ANTI-INFLAMMATORY CYTOKINES. PARTICIPATION IN THE RETREAT WAS FOUND TO BE ASSOCIATED WITH DECREASES IN SELF-REPORTED ANXIETY AND DEPRESSION AS WELL AS INCREASES IN MINDFULNESS. AS HYPOTHESIZED, INCREASES IN THE PLASMA LEVELS OF BDNF AND INCREASES IN THE MAGNITUDE OF THE CORTISOL AWAKENING RESPONSE (CAR) WERE ALSO OBSERVED. THE NORMALIZED CHANGE IN BDNF LEVELS WAS INVERSELY CORRELATED WITH BSI-18 ANXIETY SCORES AT BOTH THE PRE-RETREAT (R = 0.40, P < 0.05) AND POST-RETREAT (R = 0.52, P < 0.005) SUCH THAT THOSE WITH GREATER ANXIETY SCORES TENDED TO EXHIBIT SMALLER PRE- TO POST-RETREAT INCREASES IN PLASMA BDNF LEVELS. IN LINE WITH A HYPOTHESIZED DECREASE IN INFLAMMATORY PROCESSES RESULTING FROM THE YOGA AND MEDITATION PRACTICES, WE FOUND THAT THE PLASMA LEVEL OF THE ANTI-INFLAMMATORY CYTOKINE INTERLEUKIN-10 WAS INCREASED AND THE PRO-INFLAMMATORY CYTOKINE INTERLEUKIN-12 WAS REDUCED AFTER THE RETREAT. CONTRARY TO OUR INITIAL HYPOTHESES, PLASMA LEVELS OF OTHER PRO-INFLAMMATORY CYTOKINES, INCLUDING INTERFERON GAMMA (IFN-GAMMA), TUMOR NECROSIS FACTOR (TNF-ALPHA), INTERLEUKIN-1BETA (IL-1BETA), INTERLEUKIN-6 (IL-6), AND INTERLEUKIN-8 (IL-8) WERE INCREASED AFTER THE RETREAT. GIVEN EVIDENCE FROM PREVIOUS STUDIES OF THE POSITIVE EFFECTS OF MEDITATIVE PRACTICES ON MENTAL FITNESS, AUTONOMIC HOMEOSTASIS AND INFLAMMATORY STATUS, WE HYPOTHESIZE THAT THESE FINDINGS ARE RELATED TO THE MEDITATIVE PRACTICES THROUGHOUT THE RETREAT; HOWEVER, SOME OF THE OBSERVED CHANGES MAY ALSO BE RELATED TO OTHER ASPECTS OF THE RETREAT SUCH AS PHYSICAL EXERCISE-RELATED COMPONENTS OF THE YOGA PRACTICE AND DIET. WE HYPOTHESIZE THAT THE PATTERNS OF CHANGE OBSERVED HERE REFLECT MIND-BODY INTEGRATION AND WELL-BEING. THE INCREASED BDNF LEVELS OBSERVED IS A POTENTIAL MEDIATOR BETWEEN MEDITATIVE PRACTICES AND BRAIN HEALTH, THE INCREASED CAR IS LIKELY A REFLECTION OF INCREASED DYNAMIC PHYSIOLOGICAL AROUSAL, AND THE RELATIONSHIP OF THE DUAL ENHANCEMENT OF PRO- AND ANTI-INFLAMMATORY CYTOKINE CHANGES TO HEALTHY IMMUNOLOGIC FUNCTIONING IS DISCUSSED. 2017 15 2224 45 THE IMPACT OF THE "YOGIC LIFESTYLE" ON CANCER PROGNOSIS AND SURVIVAL: CAN WE TARGET CANCER STEM CELLS WITH YOGA? CANCER HAS RECENTLY BEEN KNOWN TO ORIGINATE FROM STEM CELL-LIKE CELLS, CALLED CANCER STEM CELLS (CSCS). THEIR UNIQUE PROPERTIES OF SELF-DUPLICATION, MULTIPLICATION, AS WELL AS MIGRATION GIVE THE CSC RESISTANCE OVER CONVENTIONAL CANCER THERAPIES. NEWER THERAPIES ARE IN DEVELOPMENTAL STAGE TO TARGET THESE STEM CELL-LIKE POPULATIONS AND BECOME THE VANGUARD OF FUTURE TREATMENTS. SEVERAL COMPLEMENTARY AND ALTERNATIVE TREATMENTS HAVE BEEN USED IN CANCER MANAGEMENT AS AN ADJUNCT TO CONVENTIONAL THERAPY TO IMPROVE THE OVERALL QUALITY OF LIFE AND REDUCE RECURRENCE. YOGA STANDS AS THE THIRD MOST POPULAR OF ALL COMPLEMENTARY AND ALTERNATIVE MEDICINE TREATMENTS CURRENTLY USED IN CANCER PATIENTS TODAY. PRELIMINARY RESULTS SHOW THAT YOGA MODULATES NEURAL, HORMONAL, AND IMMUNE FUNCTIONS AT A CELLULAR LEVEL. THE SCOPE OF THIS COMMENTARY IS TO DISCUSS THE CURRENT EVIDENCE-BASED MEDICINE ON YOGA AND ITS EFFECT ON CSCS. 2017 16 1632 32 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 17 2861 30 YOGA-BASED EXERCISE TO PREVENT FALLS IN COMMUNITY-DWELLING PEOPLE AGED 60 YEARS AND OVER: STUDY PROTOCOL FOR THE SUCCESSFUL AGEING (SAGE) YOGA RANDOMISED CONTROLLED TRIAL. INTRODUCTION: FALLS SIGNIFICANTLY REDUCE INDEPENDENCE AND QUALITY OF LIFE IN OLDER AGE. BALANCE-SPECIFIC EXERCISE PREVENTS FALLS IN PEOPLE AGED 60+ YEARS. YOGA IS GROWING IN POPULARITY AND CAN PROVIDE A HIGH CHALLENGE TO BALANCE; HOWEVER, THE EFFECT OF YOGA ON FALLS HAS NOT BEEN EVALUATED. THIS TRIAL AIMS TO ESTABLISH THE EFFECT ON FALLS OF A YOGA EXERCISE PROGRAMME COMPARED WITH A YOGA RELAXATION PROGRAMME IN COMMUNITY-DWELLERS AGED 60+ YEARS. METHOD AND ANALYSIS: THIS RANDOMISED CONTROLLED TRIAL WILL INVOLVE 560 COMMUNITY-DWELLING PEOPLE AGED 60+ YEARS. PARTICIPANTS WILL BE RANDOMISED TO EITHER: (1) THE SUCCESSFUL AGEING (SAGE) YOGA EXERCISE PROGRAMME OR (2) A YOGA RELAXATION PROGRAMME. PRIMARY OUTCOME IS RATE OF FALLS IN THE 12 MONTHS POST RANDOMISATION. SECONDARY OUTCOMES INCLUDE MENTAL WELL-BEING, PHYSICAL ACTIVITY, HEALTH-RELATED QUALITY OF LIFE, BALANCE SELF-CONFIDENCE, PHYSICAL FUNCTION, PAIN, GOAL ATTAINMENT AND SLEEP QUALITY AT 12 MONTHS AFTER RANDOMISATION. THE NUMBER OF FALLS PER PERSON-YEAR WILL BE ANALYSED USING NEGATIVE BINOMIAL REGRESSION MODELS TO ESTIMATE BETWEEN-GROUP DIFFERENCE IN FALL RATES. GENERALISED LINEAR MODELS WILL ASSESS THE EFFECT OF GROUP ALLOCATION ON THE CONTINUOUSLY SCORED SECONDARY OUTCOMES, ADJUSTING FOR BASELINE SCORES. AN ECONOMIC ANALYSIS WILL COMPARE THE COST-EFFECTIVENESS AND COST-UTILITY OF THE TWO YOGA PROGRAMMES. ETHICS AND DISSEMINATION: PROTOCOL WAS APPROVED BY THE HUMAN RESEARCH ETHICS COMMITTEE AT THE UNIVERSITY OF SYDNEY, AUSTRALIA (APPROVAL 2019/604). TRIAL RESULTS WILL BE DISSEMINATED VIA PEER-REVIEWED ARTICLES, CONFERENCE PRESENTATIONS, LAY SUMMARIES. TRIAL REGISTRATION NUMBER: THE PROTOCOL FOR THIS TRIAL IS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY (ACTRN12619001183178). 2020 18 2764 39 YOGA PROGRAMME FOR TYPE-2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH RISK PEOPLE IN INDIA: A MULTICENTRE FEASIBILITY RANDOMISED CONTROLLED TRIAL PROTOCOL. INTRODUCTION: A HUGE POPULATION IN INDIA IS AT HIGH RISK OF TYPE-2 DIABETES (T2DM). PHYSICAL ACTIVITY AND A HEALTHY DIET (HEALTHY LIFESTYLE) IMPROVE BLOOD GLUCOSE LEVELS IN PEOPLE AT HIGH RISK OF T2DM. HOWEVER, AN UNHEALTHY LIFESTYLE IS COMMON AMONG INDIANS. YOGA COVERS PHYSICAL ACTIVITY AND A HEALTHY DIET AND CAN HELP TO PREVENT T2DM. THE RESEARCH QUESTION TO BE ADDRESSED BY THE MAIN RANDOMISED CONTROLLED TRIAL (RCT) IS WHETHER A YOGA PROGRAMME FOR T2DM PREVENTION (YOGA-DP) IS EFFECTIVE IN PREVENTING T2DM AMONG HIGH RISK PEOPLE IN INDIA AS COMPARED WITH ENHANCED STANDARD CARE. IN THIS CURRENT STUDY, WE ARE DETERMINING THE FEASIBILITY OF UNDERTAKING THE MAIN RCT. INTERVENTION: YOGA-DP IS A STRUCTURED LIFESTYLE EDUCATION AND EXERCISE PROGRAMME. THE EXERCISE PART IS BASED ON YOGA AND INCLUDES SHITHILIKARANA VYAYAMA (LOOSENING EXERCISES), SURYA NAMASKAR (SUN SALUTATION EXERCISES), ASANA (YOGIC POSES), PRANAYAMA (BREATHING PRACTICES) AND DHYANA (MEDITATION) AND RELAXATION PRACTICES. METHODS AND ANALYSIS: THIS IS A MULTICENTRE, TWO-ARM, PARALLEL-GROUP, FEASIBILITY RCT WITH BLINDED OUTCOME ASSESSMENT AND INTEGRATED MIXED-METHODS PROCESS EVALUATION. ELIGIBLE PARTICIPANTS SHOULD BE AGED 18-74 YEARS, AT HIGH RISK OF T2DM (FASTING PLASMA GLUCOSE LEVEL 5.6-6.9 MMOL/L) AND SAFE TO PARTICIPATE IN PHYSICAL ACTIVITIES. AT LEAST 64 PARTICIPANTS WILL BE RANDOMISED TO INTERVENTION OR CONTROL GROUP WITH FINAL FOLLOW-UP AT 6 MONTHS. IMPORTANT PARAMETERS, NEEDED TO DESIGN THE MAIN RCT, WILL BE ESTIMATED, SUCH AS SD OF THE OUTCOME MEASURE (FASTING PLASMA GLUCOSE LEVEL AT 6-MONTH FOLLOW-UP), RECRUITMENT, INTERVENTION ADHERENCE, FOLLOW-UP, POTENTIAL CONTAMINATION AND TIME NEEDED TO CONDUCT THE STUDY. SEMISTRUCTURED QUALITATIVE INTERVIEWS WILL BE CONDUCTED WITH UP TO 20-30 PARTICIPANTS, A SAMPLE OF THOSE DECLINING TO PARTICIPATE, FOUR YOGA-DP INSTRUCTORS AND AROUND EIGHT STUDY STAFF TO EXPLORE THEIR PERCEPTIONS AND EXPERIENCES OF TAKING PART IN THE STUDY AND OF THE INTERVENTION, REASONS BEHIND NON-PARTICIPATION, EXPERIENCES OF DELIVERING THE INTERVENTION AND RUNNING THE STUDY, RESPECTIVELY. ETHICS AND DISSEMINATION: ETHICS APPROVAL HAS BEEN OBTAINED FROM THE FOLLOWING RESEARCH ETHICS COMMITTEES: FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITY OF NOTTINGHAM (UK); CENTRE FOR CHRONIC DISEASE CONTROL (CCDC, INDIA); BAPU NATURE CURE HOSPITAL AND YOGASHRAM (BNCHY, INDIA) AND SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA (S-VYASA, INDIA). THE RESULTS WILL BE WIDELY DISSEMINATED AMONG KEY STAKEHOLDERS THROUGH VARIOUS AVENUES. TRIAL REGISTRATION NUMBER: CTRI/2019/05/018893. 2020 19 1495 32 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE. 2016 20 2441 27 YOGA AND SCHIZOPHRENIA-A COMPREHENSIVE ASSESSMENT OF NEUROPLASTICITY: PROTOCOL FOR A SINGLE BLIND RANDOMIZED CONTROLLED STUDY OF YOGA IN SCHIZOPHRENIA. INTRODUCTION: SCHIZOPHRENIA IS ONE OF THE MOST SEVERE MENTAL DISORDERS WITH A PREVALENCE OF ABOUT 1% AND A LEADING CAUSE OF DISABILITY AMONG YOUNG ADULTS. PHARMACOTHERAPY IS THE MAINSTAY IN THE MANAGEMENT OF SCHIZOPHRENIA. HOWEVER, EVEN WITH THE BEST OF MEDICATION, SEVERAL PROBLEMS LIKE REFRACTORINESS, NEGATIVE SYMPTOMS, FREQUENT RELAPSES, AND COGNITIVE IMPAIRMENTS PERSIST. METHODS: THIS IS A RANDOMIZED-CONTROLLED CLINICAL STUDY INCLUDING PATIENTS FROM AN URBAN TERTIARY HOSPITAL AND A SEMI-URBAN COMMUNITY CENTER, WITH A BETWEEN-GROUP, REPEATED-MEASURES, LONGITUDINAL DESIGN. THIS STUDY WILL RECRUIT 160 PATIENTS WITH DSM 5 DIAGNOSIS OF SCHIZOPHRENIA WHO ARE ON STABLE MEDICATION FOR A MINIMUM OF 6 WEEKS; THEY WILL BE RANDOMLY ASSIGNED INTO 2 ARMS VIZ., YOGA THERAPY (YT), AND TREATMENT-AS-USUAL (TAU) WITH 80 PATIENTS IN EACH ARM. PARTICIPANTS WILL UNDERGO CLINICAL, LABORATORY, AND RADIOLOGICAL ASSESSMENTS AT BASELINE AND AT INTERVALS OF 1 MONTH, 3 MONTHS, AND 6 MONTHS FROM THE BASELINE. IT IS HYPOTHESIZED THAT YOGA WILL IMPROVE PSYCHOPATHOLOGY AND EMOTION PROCESSING, INCREASE SERUM BRAIN DERIVED NEUROTROPHIC FACTOR (BDNF) AND PLASMA OXYTOCIN LEVELS AND EFFECT CHANGES IN CEREBRAL ACTIVATION IN AREAS OF THE BRAIN ASSOCIATED WITH SCHIZOPHRENIA. DISCUSSION: THIS STUDY AIMS TO MEASURE THE EFFICACY OF A YOGA-BASED INTERVENTION AS AN ADJUNCT IN PATIENTS WITH SCHIZOPHRENIA AS WELL AS THE MECHANISMS OF THESE EFFECTS. TRIAL REGISTRATION: REGISTERED RETROSPECTIVELY WITH CLINICAL TRIAL REGISTRY - INDIA (CTRI) WITH REGISTRATION NUMBER CTRI/2017/08/009219. 2019