Yoga Arm Research Articles

Efficacy of yoga-breath linked intervention to stop smoking (Y-BLISS) in reducing the number of cigarettes smoked per day among smokers attempting to reduce or quit: Study protocol for a randomized controlled trial

Background The proposed research aims to test the effects of a two-month yoga-breath linked intervention to stop smoking (Y-BLISS) as an add-on to standard treatment in tobacco use disorder (TUD; in the form of cigarette smoking) by conducting a randomized controlled study with the following primary outcome variable: number of cigarettes smoked per day. Secondary outcome variables are motivation to stop smoking, craving, dependence severity, lung capacity, and exhaled carbon-monoxide. In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 100 patients with TUD availing the outpatient/ inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups – yoga arm (Y-bliss arm), or desktop exercise arm (D-exercise arm). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized 12-minute yoga program (Y-BLISS) for TUD will be used as an intervention. The control group will receive an equivalent 12-minute desktop exercise module. Participants in respective arms will receive 40 online supervised sessions over 8 weeks, 5 sessions per week in the mornings as they will be asked to practice the same on sos basis whenever they feel cravings for cigarette smoking. Assessments will be done at baseline, 4th week and 8thweek. Data from all randomized subjects will be analyzed using intent-to-treat analysis and mixed model multivariate analysis. Dissemination Findings will be disseminated through peer-reviewed publications, conference presentations, and social media. Trial registration number The trial has been registered under Clinical Trials Registry India (CTRI) with the registration number: CTRI/2022/12/048117, date of registration: 14th December 2022.

A randomized phase III clinical trial of yoga for chemotherapy-induced peripheral neuropathy treatment (YCT).

TPS12152 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is common and debilitating among cancer survivors receiving neurotoxic chemotherapy, which can cause functional disabilities and significantly increase the risk of falls. There are limited approaches to managing CIPN symptoms and related functional limitations. Our pilot study demonstrated yoga therapy's feasibility and preliminary efficacy in improving CIPN pain and functional outcomes. We developed the YCT trial to assess the effect of yoga therapy on improving pain and balance symptoms among cancer survivors with CIPN pain. Methods: YCT is a prospective phase III multicenter, parallel three-arm randomized clinical trial at Dana-Farber Cancer Institute (DFCI) and Memorial Sloan Kettering Cancer Center (MSK) (ClinicalTrials.gov Identifier: NCT05121558). YCT aims to determine the efficacy of an eight-week yoga treatment vs. education control (EC) vs. usual care (UC) in improving CIPN pain and balance in cancer survivors. We plan to enroll and randomize 268 participants (2:1:1) to yoga, EC, and UC groups to detect an effect size of at least 0.48 for the primary pain outcome at eight weeks post-randomization between yoga vs. EC, with 80% power and a 2.5% Type I error rate, assuming 12% attrition by week 8 and 20% attrition by week 24. Major eligibility criteria include 1) adults who have no evidence of disease or stable diseases, 2) who have completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months before enrollment, 3) who have a clinical diagnosis of CIPN with moderate to severe pain, defined as a score of at least four on the Brief Pain Inventory (BPI) average pain item, and 4) who experience self-identified CIPN balance difficulty. Eligible subjects in the yoga arm will receive hourly gentle therapeutic yoga classes taught by protocol-trained oncology yoga instructors, twice weekly for eight weeks, and practice home-based yoga. Subjects in the EC arm will receive hourly education classes taught by protocol-trained healthcare instructors twice weekly for eight weeks. Subjects in the UC arm will continue usual care for eight weeks. We offer free yoga sessions for participants in control groups after study completion. Aside from patient-reported outcome measures (i.e., BPI, FACT/GOG-Ntx, QLQ-CIPN 20), we measured functional improvements by functional reach, timed up-and-go, and chair-to-stand tests. We also conducted quantitative sensory testing to assess changes in sensory function. Progress: 1) We are transitioning this trial to a multicenter trial, with DFCI being the coordinating center and MSK a subsite; 2) As of January 18, 2024, 104 of the planned 268 participants have been enrolled. We anticipate initiating participant enrollment at DFCI in February 2024. Anticipated accrual completion: March 2025. Clinical trial information: NCT05121558 .

Opioid use disorder and role of yoga as an adjunct in management (OUDARYAM): Study protocol for a randomized controlled trial.

The proposed research aims to test the effects and mechanisms of a six-month yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study with the following primary outcome variables: 1) clinical: abstinence (opioid negative urine test), and reductions in pain and craving, and 2) mechanisms: reward circuit activation in response to opioid visual cue craving paradigm, activation in response to a cognitive control task, and resting state functional connectivity through fMRI, and plasma beta-endorphin levels. Secondary outcome variables are perceived stress, anxiety, sleep quality, cognitive performance, pain threshold, buprenorphine dosage and side effects, withdrawal symptoms, socio-occupational functioning, vedic personality traits, heart rate variability, serum cortisol, and brain GABA levels through magnetic resonance spectroscopy (MRS). In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 164 patients with OUD availing the outpatient/ inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups - yoga arm (standard treatment + yoga-based intervention), or waitlist group (standard treatment alone). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized yoga program for OUD will be used as an intervention. Participants in the yoga arm will receive 10 supervised in-person sessions of yoga in the initial two weeks followed by tele-yoga sessions thrice a week for the next 22 weeks. The wait-list control group will continue the standard treatment alone for 24 weeks. Assessments will be done at baseline, two weeks, 12 weeks, and 24 weeks. Data from all randomized subjects will be analysed using intent-to-treat analysis and mixed model multivariate analysis. Findings will be disseminated through peer-reviewed publication, conference presentations, and social media. The trial has been registered under Clinical Trials Registry-India with registration number CTRI/2023/03/050737.

Effect of Early Yoga Practice on Post Stroke Cognitive Impairment.

Post-stroke cognitive impairment (PSCI) is a clinical entity that encompasses all types of cognitive impairment following an index stroke. Yoga has been proven to have a beneficial effect not only on cardiovascular risk factors but also on cognition. Hence, this study explored the PSCI spectrum and assessed the effect of yoga on PSCI. Forty stroke patients were enrolled in each yoga and control arm in this study. After the baseline assessment, control arm was administered standard care (including physiotherapy) while yoga arm received additional yoga intervention. Change in MoCA scores by 2 points in either direction, or FAB scale by 2 points at 6 months was taken as primary outcome, whereas improvement in MRS, CDPSS, CBS, and P300 values were considered as secondary outcomes. Significant improvements were observed in MoCA, FAB, MRS, CPDSS, and CBS scores in both groups after 6 months. However, intergroup comparisons revealed better MoCA (25.5, IQR 22-27) and FAB scores (15.5, IQR 14-17) in yoga group compared to controls (24, IQR20-25.75) and (14, IQR12-15.75). Equivalent improvement was observed in MRS and CBS scores in both groups at 6 months; however, CDPSS score was better in yoga group (p = 0.0008). Both P300 amplitudes and latencies improved in all patients and median P300 amplitudes were significantly better in control group; however, no difference could be appreciated in P300 latencies improvement on intergroup comparisons at follow-up. Study reveals that early yoga intervention in stroke survivors leads to better improvement in cognitive abilities which would further facilitate in early reduction of caregiver burden.

A comprehensive yoga programme for weight reduction in children & adolescents with obesity: A randomized controlled trial.

Obesity is a rising pandemic in childhood. There is scarcity of evidence on the efficacy of yoga in achieving weight loss in overweight/obese children. The objective of this study was to assess the efficacy of family-based comprehensive yoga intervention in the reduction of body mass index (BMI) in overweight/obese children, in comparison to standard dietary and lifestyle counselling and control group. This was an open-label randomized controlled study. Children aged 8-15 yr who were overweight or had obesity were randomized to one of the three arms for 18 wk; standard weight management (group 1), yoga with dietary modification (group 2) and control (no intervention; group 3). Reduction in BMI and improvement in physiological, biochemical and psychological parameters from baseline to 18 wk was compared between the three arms. Late follow up was also done at 6-12 months. A total of 165 children with mean±standard deviation (SD) age of 11.6±1.8 yr and mean BMI 26.3±4.2 kg/m2 were enrolled. Outcome analysis at 18 wk was performed for 109 children. Improved diet quality and reduced intake were observed in both intervention arms. The median (IQR) reduction in BMI in standard and yoga arms was similar [-1.4 (-3.1, -0.5) kg/m2 and -1.2 (-2.3, -0.6) kg/m2, respectively], while it increased by +0.3 (-0.3, 0.1) in the control arm. In the yoga arm, mean systolic BP reduced from 118 (10) to 114 (8) mmHg, (P=0.019). In the standard arm, significant improvement in psychological scores was noted. In group 3, the mean fasting glucose increased from 93±10 to 102±12 mg/dl (P<0.001). The findings of the present study suggest that yoga in conjunction with dietary modification is equally effective as the standard weight management for BMI reduction in the paediatric age group.

A randomised, controlled trial of meditation and yoga in permanent atrial fibrillation: the MAYA study

Abstract Background The role of yoga in paroxysmal atrial fibrillation (AF) is known. But its role in permanent AF has not been studied. Purpose The objectives of our study are to evaluate the effects of yoga on symptoms, heart rate, quality of life, hospitalisations, medication adherence and echocardiographic parameters in permanent AF. Methods We conducted a single centre, randomised, participant blinded, parallel group, sham-controlled study between October 2019 and September 2020. We included patients aged 18–65 years with permanent AF due to any cause. Patients in New York Heart Association (NYHA) class≥3, modified European Heart Rhythm Association (mEHRA) class ≥3 and left ventricular ejection fraction (LVEF)&amp;lt;30% were excluded. Total of 84 patients underwent randomisation into two groups of 42 each. None of the participants had prior knowledge or contraindications to yoga. Subjects in yoga arm underwent supervised and self-performed yoga sessions consisting of various asanas, pranayamas and dhyana, while those in the sham arm underwent supervised and self-performed joint exercises, each session lasting for 60 minutes/day for 6 days a week along with guideline directed medical therapy in both arms. The primary endpoints were improvement in NYHA class, mEHRA class, heart rate at rest and after 6 minute walk test, 6 minute walk distance, quality of life, medication adherence, hospitalisations, LVEF and left atrial volume index at 3 months. The secondary endpoints included the same parameters assessed at 1month. Quality of life was assessed by the short form (SF)-36 questionnaire which has eight domains. Scores for each domain range from 0 to 100, with a higher score defining a more favourable health state. All analyses were based on intention to treat principle. Results The groups were well-matched at baseline. The mean age of study participants was 50.62±12.97 years, 56% were women and the most common risk factor was rheumatic heart disease found in 47.6% of the cases. Four patients in the yoga group and 3 in the sham group were lost to follow up. There was significant improvement in various parameters in the yoga arm at 1 and 3 months. (Figures 1 and 2). Hospitalisation at 3 months was lower in the yoga arm (0.73±0.81) versus sham arm (1.13±0.93); p=0.044. Out of 38 patients in the yoga arm, 6 patients had improvement in the medication adherence compared to 9 patients (out of 39) in the sham arm at 3 months, p=0.419, OR (95% CI) = 0.62 (0.19–1.96). Higher the compliance to yoga, defined by the number of sessions per week, more was the improvement in various parameters. No harms were noted. Conclusion Among patients of permanent AF already on medical therapy, yoga significantly improves symptoms, heart rate, functional capacity, quality of life and hospitalisations when compared to a sham procedure. Larger, multicentre, double blinded studies are required to generalise the results, though participant blinding cannot be 100% assured. Funding Acknowledgement Type of funding sources: None.

Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes.

BackgroundYoga is a meditative movement therapy focused on mind‐body awareness. The impact of yoga on health‐related quality of life (HRQOL) outcomes in patients with chemotherapy‐induced peripheral neuropathy (CIPN) is unclear.MethodsWe conducted a pilot randomized wait‐list controlled trial of 8 weeks of yoga (n = 21) versus wait‐list control (n = 20) for CIPN in 41 breast and gynecological cancer survivors with persistent moderate to severe CIPN. HRQOL endpoints were Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). The Treatment Expectancy Scale (TES) was administered at baseline. We estimated mean changes and 95% confidence intervals (CIs) from baseline to weeks 8 and 12 and compared arms using constrained linear mixed models.ResultsAt week 8, HADS anxiety scores decreased −1.61 (−2.75, −0.46) in the yoga arm and −0.32 (−1.38, 0.75) points in the wait‐list control arm (p = 0.099). At week 12, HADS anxiety scores decreased −1.42 (−2.57, −0.28) in yoga compared to an increase of 0.46 (−0.60, 1.53) in wait‐list control (p = 0.017). There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait‐list control. Baseline TES was significantly higher in yoga than in wait‐list control (14.9 vs. 12.7, p = 0.019). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction.ConclusionsYoga may reduce anxiety in patients with CIPN. Future studies are needed to confirm these findings.Clinical Trial Registration Number: ClinicalTrials.gov Identifier: NCT03292328.

Abstract PS9-19: Health-related quality of life (HRQOL) outcomes in arandomized controlled trial of yoga in breast and gynecological cancer survivors with chemotherapy-induced peripheral neuropathy

Abstract Background: Yoga is a meditative movement therapy that improves body conditioning, flexibility, and balance through mind-body awareness. We conducted a two-armed pilot randomized wait-list controlled trial in breast and gynecological (GYN) cancer survivors with persistent moderate to severe chemotherapy-induced peripheral neuropathy (CIPN) and found that yoga significantly reduced CIPN pain. Here we report on the HRQOL results. Patients and Methods: We randomized breast and GYN cancer survivors with persistent moderate to severe CIPN to eight weeks of yoga or usual care (UC). The HRQOL endpoints were Hospital Anxiety and Depression Score (HADS), Treatment Expectancy Scale (TES), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). We estimated and compared the mean changes from baseline to weeks 8 and 12 along with 95% confidence intervals (CIs) between arms using linear mixed models. Results: From February 2018 to May 2019, we enrolled and randomized 41 female cancer survivors (93% breast, 7% GYN; mean (SD) age 61.7 (10.2) years; 56% white/non-Hispanic, 20% African American, 12% Asian, 12% other) to yoga (N=21) and UC (N=20) arms. The HADS anxiety score significantly reduced in the yoga arm compared to usual care at weeks 8 and 12. At baseline, the mean (95% CI) HADS anxiety score was 9.23 (7.42, 11.04) in the yoga arm, and 5.05 (3.19, 6.91) in the UC arm (p=0.002). At week 8, the mean (95% CI) HADS anxiety score decreased by -1.91 (-3.07, -0.76) points in the yoga arm, and by -0.02 (-1.10, 1.06) points in the UC arm (p=0.019). At week 12, in the yoga arm, the mean HADS anxiety score was 7.50 (5.62, 9.39), and a decrease of 1.73 (-2.88, -0.57) points; in the UC arm, the mean was 5.81 (3.94, 7.69) with an increase of 0.76 (-0.32, 1.84) points (p=0.002). There was no difference in HADS depression, BFI, and ISI scores between yoga and UC arms at baseline, week 8, and week 12. The TES at baseline was 14.9 (3.27) in the yoga arm, which was significantly higher than in the UC arm 14.9 (SD 3.27) vs. 12.7 (SD: 2.58), p= 0.019. The TES was not associated with HADS anxiety reduction, and HADS anxiety reduction was not associated with CIPN pain reduction. Conclusions: Our trial showed that a yoga intervention may be useful to reduce anxiety in patients with CIPN. We previously found that a yoga intervention reduced CIPN pain. CIPN pain reduction was not associated with anxiety reduction or TES. Future studies are needed to confirm our findings and to explore the mechanism of yoga in CIPN pain reduction. Citation Format: Wanqing Iris Zhi, Raymond Baser, Lillian Zhi, Lauren Piulson, Qing Li, Ting Bao. Health-related quality of life (HRQOL) outcomes in arandomized controlled trial of yoga in breast and gynecological cancer survivors with chemotherapy-induced peripheral neuropathy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-19.

Abstract LB-292: A randomized controlled trial of yoga in men with prostate cancer undergoing radical prostatectomy

Abstract Introduction and Objectives: New diagnosis of prostate cancer (PCa) may lead to anxiety, mental distress, fear and depression in up to 30% of men, which can contribute to poor quality of life (QOL). Recent research on Yoga in cancer patients has shown significant improvement in health related QOL, emotional health and fatigue. Given the lack of randomized clinical data regarding the effects of Yoga in PCa, we performed this study to evaluate the potential impact of Yoga on disease-specific QOL in men undergoing radical prostatectomy (RP) for PCa. Material and Method: We randomly assigned newly diagnosed men with localized prostate cancer to Yoga (n = 15) or standard of care (n= 15) prior to their RP. Yoga was given to the intervention group twice a week for 6 weeks for 60 minutes before the surgery and then re-initiated 3 to 6 weeks after the surgery for another six weeks. Self-report measures of QOL [ Expanded Prostate Index Composite (EPIC), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Functional Assessment of Cancer Therapy-General (FACT-G) and Five Facets of Mindfulness Questionnaire (FFMQ) primary outcomes], blood specimen (cytokine and immune markers; secondary outcome) were collected at baseline, prior to the surgery and 6 weeks after surgery. Results: Improvements in EPIC sexual domain (mean difference: 8.5 points), FACT-P (mean difference: 5.3 points), FACIT-F (mean difference: 5.4 points), and FACT-G (mean difference: 7.2 points) were seen at 6 weeks in the Yoga arm compared with controls. Greatest benefit of Yoga was seen in the subdomains of EPIC sexual function (mean difference: 8.9 points), EPIC sexual bother (mean difference: 7.6 points), FACT emotional wellbeing (mean difference: 5.4 points), FACT functional wellbeing (mean difference 8.3 points) and FACT social wellbeing (mean difference 14.1 points). We identified statistically significant reduction in the inflammatory cytokines- granulocyte colony-stimulating factor (G-CSF; 0.55 [0.05 - 1.05]; p-value = 0.03), Monocyte chemoattractant protein (MCP-1; 0.22 [0.01 - 0.43]; p-value = 0.04), FMS-like tyrosine kinase-3 ligand (FLT-3 L; 0.91 [-0.01 - 1.82]; p-value = 0.053) in the Yoga group during the same time period. Conclusions: A structured Yoga intervention in the preoperative setting improved QOL, especially in the domains of sexual function, social, emotional and functional well-being as well as fatigue. Yoga positively modulates chronic low-grade inflammation which may impact tumor microenvironment. Yoga is feasible and safe and has promising benefits to physical, mental and emotional well-being. Health care providers can utilize the preoperative period as a window of opportunity for an intervention and a teaching moment for the patient to enhance their overall health. Further integrated large-scale research into molecular impact of yoga on markers of inflammation and immune function are essential. Source of Funding: This project was supported by the ThriveWell Cancer Foundation grant to Dharam Kaushik. The content is solely the responsibility of the authors and does not necessarily represent the official views of the ThriveWell Cancer Foundation. Citation Format: Dharam Kaushik, Pankil Shah, Kumar A. Pratap, Ian M. Thompson, Robert S. Svatek, Javier Hernandez, Ian Thompson, Ahmed Mansour, Richapriya Jha, Yang Xiaoyu, Deepak K. Pruthi, Hanzhang Wang, J. Ricardo Rivero, Nydia Darby, Ronald Rodriguez, Michael A. Liss. A randomized controlled trial of yoga in men with prostate cancer undergoing radical prostatectomy [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr LB-292.

Yoga for Chemotherapy-Induced Peripheral Neuropathy and Fall Risk: A Randomized Controlled Trial.

BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect that worsens quality of life and increases the risk of falls in cancer survivors. Evidence of yoga’s safety and efficacy in treating CIPN is lacking.MethodsIn a randomized controlled study, we assigned breast and gynecological cancer survivors with persistent moderate-to-severe CIPN pain, numbness, or tingling with a score of 4 or greater (0-10 numeric rating scale [NRS]) for at least 3 months after chemotherapy to 8 weeks of usual care or yoga focused on breathwork and musculoskeletal conditioning. Primary endpoint was treatment arm differences for NRS, and secondary endpoints were Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx), and Functional Reach Test after week 8. We tested treatment arm differences for each outcome measure using linear mixed models with treatment-by-time interactions. All statistical tests were two-sided.ResultsWe randomly assigned 41 participants into yoga (n = 21) or usual care (n = 20). At week 8, mean NRS pain decreased by 1.95 points (95% confidence interval [CI] = -3.20 to -0.70) in yoga vs 0.65 (95% CI = -1.81 to 0.51) in usual care (P = .14). FACT/GOG-Ntx improved by 4.25 (95% CI = 2.29 to 6.20) in yoga vs 1.36 (95% CI = -0.47 to 3.19) in usual care (P = .035). Functional reach, an objective functional measure predicting the risk of falls, improved by 7.14 cm (95% CI = 3.68 to 10.59) in yoga and decreased by 1.65 cm (95% CI = -5.00 to 1.72) in usual care (P = .001). Four grade 1 adverse events were observed in the yoga arm.ConclusionAmong breast and gynecological cancer survivors with moderate-to-severe CIPN, yoga was safe and showed promising efficacy in improving CIPN symptoms.

Abstract P5-14-02: Yoga for chemotherapy-induced peripheral neuropathy and fall risk in breast and gynecological cancer survivors: A pilot study

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating and dose-limiting side effect of neurotoxic chemotherapies that worsens quality of life and increases fall risk in cancer survivors. CIPN is painful and poorly managed with pharmacological agents.This pilot study assessed the preliminary effect of yoga on CIPN symptom severity and fall risk in cancer survivors.Methods: Breast and gynecological (GYN) cancer survivors with persistent, moderate-to-severe CIPN were randomized to yoga and usual care (UC) control arms. The yoga arm practiced Hatha yoga for 60 minutes daily via an in-person group class (2 times/week) and at home using a study-provided instructional video (5 times/week), and the UC arm received usual care for 8 weeks. Main study outcomes included a numeric rating scale (NRS) of CIPN pain, numbness and tingling (higher score indicates worse symptom); the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicitysubscale (FACT-GOG/Ntx) (higher score indicates improved symptoms); and functional reach (FR) test, an objective balance test used to evaluate fall risk (higher score indicates lower risk of fall). Mean changes from baseline to week 8 were calculated for each outcome measure and compared between treatment arms using two-sample t-tests. Results: From 2/2018 to 5/2019, 41 female cancer survivors (92.7% breast, 7.3% GYN; mean (SD) age 62.6 (10.2) years; 53.7% white/non-Hispanic, 19.5% African American, 12.2% Asian, 12.2% other) were enrolled and randomized to yoga (N=21) and UC (N=20) arms. At week 8, mean NRS pain decreased by 2.06 points (95% CI [-3.27, -0.86]) in the yoga arm, and 0.65 points [-2.08, 0.78] in the UC arm (p=0.12). No statistically significant change was observed in NRS numbness and tingling for yoga versus UC arms (both p&amp;gt;0.5). FACT-GOG/Ntx improved by 4.56 points [-1.84, 7.29] in the yoga arm, and 1.37 points [-0.51, 3.25] in the UC arm (p=0.05). FR improved by 3.08 inches [-1.43, 4.73] in the yoga arm, and decreased 0.59 inches [-0.51, 3.25] in the UC arm (p=0.003). Four yoga and 3 UC subjects reported a total of 11 adverse events deemed possibly related to the yoga intervention (all grade 1). Conclusion: Among breast and GYN cancer survivors with moderate-to-severe CIPN, yoga showed promising effects for improving neuropathy-related pain and quality of life, and for reducing fall risk. An adequately-powered and appropriately-controlled trial is warranted to confirm the specific and long-term effects of yoga on CIPN symptoms and fall prevention. Citation Format: Ting Bao, Madeline Hooper, Raymond Baser, Patricia Chen, Lauren Piulson, Clare Patterson, Tina Paul, Connie Chen, Qing Li, Katherine Panageas, Iris Zhi, Victoria Blinder, Mark Robson, Andrew Seidman, Jun Mao. Yoga for chemotherapy-induced peripheral neuropathy and fall risk in breast and gynecological cancer survivors: A pilot study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-14-02.

Prospective randomized trial of standard antiemetic therapy with yoga versus standard antiemetic therapy alone for highly emetogenic chemotherapy-induced nausea and vomiting in South Asian population.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing side effects of highly emetogenic chemotherapy regimens. There have been continuous efforts in the direction to control CINV by many investigators. Randomly selected patients were those receiving highly emetogenic chemotherapy regimen grouped into yoga and standard antiemetic therapy (n = 50) just before receiving chemotherapy and continued for the following days and other group (n = 50) received only the standard antiemetic agent. Both the groups were assessed, followed for acute and delayed onset of chemotherapy-induced and anticipatory nausea and vomiting using radiation therapy oncology group grading for the same. We also assessed the quality of life of the patient using the Functional Assessment of Cancer Therapy-General questionnaire. The median age group of the patients was 51 years with male:female ratio 2:1, The Eastern Cooperative Oncology Group (ECOG) performance status was 0/1 in 38% of the selected population, while ECOG 2 in 62% of the patients. In yoga arm, insignificant reduction in chemotherapy-induced nausea (90% vs. 78%, P = 0.35) and but significant reduction in vomiting (42% vs. 22%, P =0.01) was observed as compared to the standard antiemetics only arm. There was a significant reduction in Grade 2 and 3 nausea (84% vs. 38% P < 0.01) and vomiting (14% vs. 0% P < 0.01). Quality of life is also significantly improved in the yoga arm, especially in the ECOG 2 performance status. This study concludes that yoga along with standard antiemetic medication should be a part of the management plan for the cancer patients receiving highly emetogenic chemotherapy.

5-HTTLPR and MTHFR 677C>T polymorphisms and response to yoga-based lifestyle intervention in major depressive disorder: A randomized active-controlled trial.

Background:There is growing evidence suggesting that both genetic and environmental factors modulate treatment outcome in, a highly heterogeneous, major depressive disorder (MDD). 5-HTTLPR variant of the serotonin transporter gene (SLC6A4) and MTHFR 677C>T polymorphisms have been linked to the pathogenesis of MDD, and antidepressant treatment response. The evidence is lacking on the clinical utility of yoga in patients with MDD who have 5-HTTLPR and MTHFR 677C>T polymorphisms and less likely to respond to medications (SSRIs).Aims:We aimed to examine the impact of YBLI in those who have susceptible 5-HTTLPR and MTHFR 677C>T polymorphisms and are less likely to drug therapy with SSRIs.Settings and Design:In a 12 week randomized active-controlled trial, MDD patients (n = 178) were randomized to receive YBLI or drug therapy.Methods:Genotyping was conducted using PCR-based methods. The clinical remission was defined as BDI-II score ≤ 9.Statistical Analysis Used:An intent-to-treat analysis was performed, and the association of genotype with treatment remission consisted of the logistic regression model. A P value of <0.05 was considered statistically significant.Results:Multivariate logistic regression models for remission including either 5-HTTLPR or MTHFR 677C>T genotypes showed statistically significant odds of remission in YOGA arm vs. DRUG arm. Neither 5-HTTLPR nor MTHFR 677C>T genotype showed any influence on remission to YBLI (P = 0.73 and P = 0.64, respectively). Further analysis showed childhood adversity interact with 5-HTTLPR and MTHFR 677C>T polymorphisms to decrease treatment response in DRUG treatment arm, but not in YOGA arm.Conclusions:YBLI provides MDD remission in those who have susceptible 5-HTTLPR and MTHFR 677C>T polymorphisms and are resistant to SSRIs treatment. YBLI may be therapeutic for MDD independent of heterogeneity in its etiopathogenesis.

Effect of Eischens Yoga During Radiation Therapy on Prostate Cancer Patient Symptoms and Quality of Life: A Randomized Phase II Trial

A randomized phase II study was performed to measure the potential therapeutic effects of yoga on fatigue, erectile dysfunction, urinary incontinence, and overall quality of life (QOL) in prostate cancer (PCa) patients undergoing external beam radiation therapy (RT). The participants were randomized to yoga and no-yoga cohorts (1:1). Twice-weekly yoga interventions were offered throughout the 6- to 9-week courses of RT. Comparisons of standardized assessments were performed between the 2 cohorts for the primary endpoint of fatigue and the secondary endpoints of erectile dysfunction, urinary incontinence, and QOL before, during, and after RT. From October 2014 to January 2016, 68 eligible PCa patients underwent informed consent and agreed to participate in the study. Of the 68 patients, 18 withdrew early, mostly because of treatment schedule-related time constraints, resulting in 22 and 28 patients in the yoga and no-yoga groups, respectively. Throughout treatment, those in the yoga arm reported less fatigue than those in the control arm, with global fatigue, effect of fatigue, and severity of fatigue subscales showing statistically significant interactions (P<.0001). The sexual health scores (International Index of Erectile Function Questionnaire) also displayed a statistically significant interaction (P=.0333). The International Prostate Symptom Score revealed a statistically significant effect of time (P<.0001) but no significant effect of treatment (P=.1022). The QOL measures had mixed results, with yoga having a significant time by treatment effect on the emotional, physical, and social scores but not on functional scores. A structured yoga intervention of twice-weekly classes during a course of RT was associated with a significant reduction in pre-existing and RT-related fatigue and urinary and sexual dysfunction in PCa patients.

A Randomized controlled trial of the effect of yoga and peer support on glycaemic outcomes in women with type 2 diabetes mellitus: a feasibility study

BackgroundType two diabetes is a complex and demanding chronic disease and its impact in a state (Kerala) which leads India in terms of the number of people with Diabetes is profound. Though the male to female ratio among the people with diabetes is roughly equal, women are uniquely and more severely affected. Management of type two Diabetes requires considerable dexterity on the part of the patient to manage drugs, diet and exercise. Therefore, in a low middle-income country like India it is necessary to look at low cost interventions that can empower the patient and build on available resources to help manage diabetes. Hence, we studied the feasibility and effect of two low cost interventions; yoga and peer support on glycaemic and other outcomes among women with type two diabetes.MethodsAn open label parallel three armed randomized control trial was conducted among 124 recruited women with Diabetes for three months. Block randomization with a block length of six was carried out with each group having at least 41 women. In the Yoga arm, sessions by an instructor, consisting of a group of postures coordinated with breathing were conducted for an hour, two days a week. In the peer support arm each peer mentor after training visited 13–14 women with diabetes every week followed by a phone call. The meeting was about applying disease management or prevention plans in daily life.ResultsThere was a trend in decline of fasting plasma glucose in the peer and yoga group and of glycosylated haemoglobin (HbA1c) in the yoga group only, though not significant. A significant decrease was observed in diastolic blood pressure and hip circumference in the yoga group. The process indicated that most (80%) of the women in the yoga group attended classes regularly and 90% of the women in the peer group reported that peer mentoring was useful.ConclusionThe effect of yoga and peer support on glycaemic outcomes was incremental. Longer term studies are necessary to ascertain the benefits shown by this feasibility study.Trial registrationCTRI/2011/12/002227 dated 14/12/2011.

The Effect of Yoga and Peer Support Interventions on the Quality of Life of Women with Diabetes: Results of a Randomized Controlled Trial.

Objective:This was an interventional study to understand the effect of two low-cost interventions; yoga and peer support on the quality of life (QOL) of women with type 2 diabetes.Methodology:An open label parallel three-armed randomized control trial was conducted among 124 recruited women with diabetes for 3 months. Block randomization with a block length of six was carried out. In the yoga arm, sessions by an instructor, consisting of a group of postures coordinated with breathing were conducted for an hour, 2 days a week. In the peer support arm, each peer mentor after training visited 13–14 women with diabetes every week followed by a phone call. The meeting was about applying disease management plans in daily life. At the beginning and end of the study, QOL was assessed by the translated, validated World Health Organization QOL-BREF in four domains physical, psychological, social, and environmental domains.Results:The majority (96%) of the study participants perceived the peer support and yoga intervention to be beneficial. Paired t-test revealed significant increases in the social and environmental domain in the peer group and in the environmental domain in the yoga group, though this disappeared in the between-group comparison perhaps due to poor glycemic control (hemoglobin A1c varied from 9.4 to 9.6) and the short duration of 3 months of the study.Conclusion:Peer support and yoga improved perceptions of QOL though its impact on scores was not significant due to a short period of study among women with poor glycemic control.

380P Prospective randomized trial of standard antiemetic therapy with yoga versus standard antiemetic therapy alone for highly emetogenic chemotherapy induced nausea and vomiting in South Asian population

Aim/Background: Chemotherapy induced nausea and vomiting is one of the most distressing side effects of highly emetogenic chemotherapy regimens. There have been continuous efforts in the direction to control Chemotherapy induced nausea and vomiting (CINV) by many investigators.Methods: Randomly selected patients were those receiving highly emetogenic chemotherapy regimen grouped into yoga and standard antiemetic therapy (n = 50) just prior to receiving chemotherapy and continued for the following days and other group (n = 50) received only the standard antiemetic agent. Both the groups were assessed, followed for acute and delayed onset of chemotherapy induced and anticipatory nausea and vomiting using RTOG grading for the same. We also assessed the Quality of Life of the patient using the FACT-G questionnaire.Results: The median age group of the patients was 51 years with M:F 2:1, ECOG performance status 0/1,2 38% v/s 62%. In Yoga arm insignificant reduction in chemotherapy induced nausea (90% vs 78%, p =.35) and but significant reduction in vomiting (42% vs 22%, p =.01) was observed as compared to the standard antiemetics only arm. There was significant reduction in grade 2 and 3 nausea (84% vs 38% p <.01) and vomitting (14% vs 0% p <.01). Quality of Life is also significantly improved in the Yoga arm especially in ECOG 2 performance status.Conclusions: This study concludes that Yoga along with standard antiemetic medication should be a part of the management plan for the cancer patients receiving highly emetogenic chemotherapy.Disclosure: All authors have declared no conflicts of interest. Aim/Background: Chemotherapy induced nausea and vomiting is one of the most distressing side effects of highly emetogenic chemotherapy regimens. There have been continuous efforts in the direction to control Chemotherapy induced nausea and vomiting (CINV) by many investigators. Methods: Randomly selected patients were those receiving highly emetogenic chemotherapy regimen grouped into yoga and standard antiemetic therapy (n = 50) just prior to receiving chemotherapy and continued for the following days and other group (n = 50) received only the standard antiemetic agent. Both the groups were assessed, followed for acute and delayed onset of chemotherapy induced and anticipatory nausea and vomiting using RTOG grading for the same. We also assessed the Quality of Life of the patient using the FACT-G questionnaire. Results: The median age group of the patients was 51 years with M:F 2:1, ECOG performance status 0/1,2 38% v/s 62%. In Yoga arm insignificant reduction in chemotherapy induced nausea (90% vs 78%, p =.35) and but significant reduction in vomiting (42% vs 22%, p =.01) was observed as compared to the standard antiemetics only arm. There was significant reduction in grade 2 and 3 nausea (84% vs 38% p <.01) and vomitting (14% vs 0% p <.01). Quality of Life is also significantly improved in the Yoga arm especially in ECOG 2 performance status. Conclusions: This study concludes that Yoga along with standard antiemetic medication should be a part of the management plan for the cancer patients receiving highly emetogenic chemotherapy. Disclosure: All authors have declared no conflicts of interest.

Yoga Combined With Health Education for Risk Reduction of Metabolic Syndrome: A Randomized Controlled Pilot Feasibility Study

Objective: The primary treatment for adults with risk factors for metabolic syndrome is lifestyle change, though adoption of traditional lifestyle programs is often limited. This pilot study tested the feasibility of conducting a randomized clinical trial comparing a novel targeted yoga program coupled to lifestyle education versus lifestyle education alone among adults with metabolic syndrome risk factors. Design and methods: Patients from primary care clinic were pre-screened electronically and further screened for metabolic syndrome. Consented participants were randomized to either a 12-week yoga program with lifestyle education or lifestyle education alone. Participants in the yoga arm received weekly 30 to 45 min of face-to-face yoga instruction, followed by 30 to 45 min of lifestyle education, and written instructions for home yoga practice and lifestyle changes. The lifestyle education was based on (EDU) the Group Lifestyle Balance Program that is adapted from the Diabetes Prevention Program. Participants in EDU only group received a weekly standardized curriculum matched in attention and time to the yoga with EDU arm. The primary outcome was to assess the feasibility of conducting a randomized trial by assessing recruitment rate and adherence to the protocol. Secondly, we aimed to collect preliminary data on changes in cardiometabolic factors including insulin resistance (IR) as measured by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), blood pressure, fasting lipids, body weight and composition, habitual physical activity, and dietary intake from baseline to 12-week intervention. Results: We identified 238 adults at high risk for metabolic syndrome medical records review utilizing an electronic recruitment tool. Among eligible individuals, 67 (28%) were enrolled and 56 (84%) completed the 12-week assessment. The median attendance was 8 of 12 sessions for the yoga with EDU and 9 of 12 sessions for the EDU arm. Self-reported median frequency of home practice was 2.8 (IQR 1.4) times per week among the yoga with EDU group and 3.3 (IQR 1.1) times per week among the EDU group. Participants in the yoga with EDU arm versus EDU alone demonstrated a non-significant decrease in HOMA-IR (-0.21 (S.D. 0.99) versus 0.02 (S.D. 0.74), p=0.29). Both groups had similar changes in blood pressure, lipids, weight, body composition, energy intake, and physical activity from baseline to 12 weeks. Conclusions: It is feasible to implement yoga combined with EDU and conduct a prospective trial to assess effectiveness on cardiometabolic risk reduction in adults with metabolic syndrome.

Improvements in ICF Components in Individuals With Chronic Stroke Following a Yoga-Based Intervention

Objective: To understand perceived outcomes following a yoga intervention for individuals with chronic stroke, framed within the context of the International Classification of Functioning, Disability, and Health. Design: Small, prospective mixed-method, randomized controlled trial of a yoga intervention for individuals at least 6 months post-stroke. Setting: Community-based rehabilitation laboratory. Participants: Forty-seven individuals were randomized to either the intervention or the wait-list control. Twenty-six individuals from the yoga arm agreed to participate in the focus groups. Individuals were eligible for the study if they were >6 months post-stroke and had completed all stroke related rehabilitation. Interventions: The yoga-based intervention was one-hour, twice per week, for a total of 16 yoga classes. Main Outcome Measure(s): Five focus groups occurred during the final week of the yoga intervention. A semi-structured focus group guideline was developed to include questions and probes. Data were analyzed using interpretative phenomenological analysis. Results: Two main themes emerged around domains of the ICF: improvements in body structures and functions; and improvements in activity and participation. In terms of body structure and functions, many study participants discussed substantial perceived changes in both mental and physical functioning, including improved emotional regulation, improvements in stability and range of motion, and unanticipated improvements, such as increases in vision, increased sensation perception, and reduction of diabetic complications. Many study participants commented on the benefits and increases in various activities and participation due to their involvement in the post-stroke yoga intervention. Conclusions: Qualitative data indicated that changes in body function allowed for improved activity and participation.

OA10.03. Improved activity, participation, and quality of life for individuals with chronic stroke following an 8-week yoga intervention

Methods For this pilot study, individuals were randomized 3:1 into the experimental group or wait list control. Forty-seven individuals were recruited into the study, with 37 individuals randomized to the yoga arm, and 10 randomized into the control group. Twenty-nine individuals completed the yoga intervention (22% attrition). The yoga intervention occurred twice per week for 1 hour each session, and was designed for individuals with chronic stroke (>6 months post event). All yoga classes were led by a registered yoga therapist. To measure activity and participation, the ICF Measure of Participation and Activity (IMPACT) subscales were utilized (lower scores indicate higher activity or participation). To measure quality of life, the Stroke Survivor Quality of Life (SSQOL) scale was utilized. Paired t-tests were utilized to compare the baseline and 8-week scores on each of the measures for both groups.