Yoga for Cardiovascular Disease
(SLYM II Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Disqualifiers: Congestive heart failure, COPD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The aim of the prospective randomized single center study is to evaluate the effect of a short-term (16 weeks) yoga program on micro RNA (miRNA) expression and cardiovascular disease (CVD) risk factors in patients with CVD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Chair Yoga, Accessible Yoga, Adaptive Yoga, Seated Yoga for cardiovascular disease?
Is yoga safe for people with cardiovascular disease?
How does the treatment Chair Yoga differ from other treatments for cardiovascular disease?
Chair Yoga is unique because it offers a gentle, accessible form of exercise that can be done while seated, making it suitable for individuals with limited mobility or those who face barriers to traditional exercise. It focuses on gentle stretching and breathing, which can improve heart health and quality of life without the need for intense physical activity.110111213
Eligibility Criteria
Adults aged 18-80 with metabolic syndrome and cardiovascular disease who have undergone certain heart procedures or have risk factors like high blood pressure can join. They must be able to do yoga and follow the study plan. People with severe heart failure, arrhythmias, implants, autoimmune diseases, recent transplants or pregnancy, severe lung disease, liver issues or heavy alcohol use cannot participate.Inclusion Criteria
I had a heart procedure at Mount Sinai or have heart disease risk factors.
I am between 18 and 80 years old.
I have been diagnosed with metabolic syndrome, having at least three of the specified conditions.
See 1 more
Exclusion Criteria
I have heart issues or metal implants in my body.
I do not drink more than the recommended amount of alcohol weekly.
I have severe breathing problems or a serious illness.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants practice yoga poses in a chair for 30 minutes at least 3 days a week for 16 weeks or follow standard of care treatment
16 weeks
Weekly yoga sessions (self-guided)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood samples collected for miRNA expression profile
22 months
Follow-up visit at 16 weeks and end of study at 22 months
Treatment Details
Interventions
- Chair Yoga (Behavioral Intervention)
Trial OverviewThe trial is testing if a 16-week chair yoga program can change micro RNA expression linked to heart disease and improve related health markers in patients with cardiovascular conditions.
Participant Groups
2Treatment groups
Active Control
Group I: YogaActive Control1 Intervention
Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks
Group II: Standard of CareActive Control1 Intervention
Control group patients will follow standard of care (SOC) treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Sinai HospitalNew York, NY
Loading ...
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
Effects of yoga on cardiovascular disease risk factors: a systematic review and meta-analysis. [2022]The aim of this review was to systematically assess and meta-analyze the effects of yoga on modifiable biological cardiovascular disease risk factors in the general population and in high-risk disease groups.
A systematic review of yoga for heart disease. [2022]This systematic review of randomized controlled trials (RCTs) aimed to evaluate the quality of evidence and the strength of recommendation for yoga as an ancillary intervention for heart disease.
Development of a yoga module targeting cardiovascular health for patients with post-myocardial left ventricular dysfunction in India. [2019]Yoga is known to contribute towards cardiovascular health. This paper describes the development of a need-based yoga program which is suitable to be integrated into the cardiac rehabilitation of post-myocardial infarction patients with left ventricular dysfunction.
Appropriateness and acceptability of a Tele-Yoga intervention for people with heart failure and chronic obstructive pulmonary disease: qualitative findings from a controlled pilot study. [2022]Heart failure (HF) and chronic obstructive pulmonary disease (COPD) are highly prevalent and associated with a large symptom burden, that is compounded in a dual HF-COPD diagnosis. Yoga has potential benefit for symptom relief; however functional impairment hinders access to usual yoga classes. We developed a Tele-Yoga intervention and evaluated it in a controlled pilot trial. This paper reports on the appropriateness and acceptability of the intervention and the evaluation design.
Integrated Yoga Practice in Cardiac Rehabilitation Program: A Randomized Control Trial. [2021]Background: Coronary artery disease (CAD) is a detrimental noncommunicable disease, which is increasing due to sedentary lifestyle and urbanization in the young population. It is further elevated with risk factors such as stress, anxiety, depression, an increase in triglycerides, dyslipidemia, hyperglycemia, hypertension, and so on, which manifests as atherosclerotic disease. Yoga-based lifestyle intervention is a noninvasive effective treatment method to control and prevent cardiac risk factors in CAD patients. Yoga has been used in India as a therapeutic method to manage hypertension and other chronic disorders and is fast gaining popularity as an effective means for the alleviation of stress, improvement of fitness, and enhancement of well-being. This study aimed to determine the feasibility of introducing the integrated approach of yoga therapy (IAYT) in a cardiac rehabilitation center in India and understand its usefulness in improving the cardiac function and managing the cardiac risk factors in acute myocardial infarction patients with left ventricular dysfunction. Methods and Design: Cardiac patients were randomized to a yoga-practicing group (n = 33) and a control group (n = 33). The yoga-practicing group was instructed to attend three supervised IAYT classes 3 days per week for 12 weeks at the hospital yoga center. The control group received standard care that included pharmacologic treatment and the instructions of the cardiologist. The outcome measures were assessed at baseline (T1 = 0) and completion (T2 = 3 months). The primary outcome measure was the left ventricular ejection fraction (LVEF). Results: There was no statistically significant difference in LVEF (U = 420.500, p value = 0.218) between the two groups. However, the yoga-practicing group showed significant reduction in depression (Cardiac Depression Scale [CDS], U = 71, p value = 0.0), anxiety (Hamilton Anxiety Rating Scale [HAM-A], U = 128, p value = 0.0), and a significant increase in quality of life (QOL) scores (Duke Activity Status Index [DASI], U = 146, p value = 0.0; and metabolic equivalents (METs), U = 136, p value = 0.0) at 3 months compared to control. Overall, the CAD patients practicing yoga showed a favorable profile compared to control individuals on CDS, HAM-A, DASI, and MET outcomes. Control and yoga practicing groups did not differ significantly in the lipid levels. Conclusion: This study indicated that the integration of yoga practice in a cardiac rehabilitation program is feasible and has no added benefit in improving the cardiac function. However, the addition of yoga to cardiac rehabilitation may be beneficial in reducing depression and anxiety and improving QOL in patients.
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P
Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. [2020]Objectives: This study examines the prevalence of exposure to adverse events and associations with stress levels among a diverse population-based sample of young people. The study further explores whether these vulnerable populations, who have the potential to benefit from the mind-body practice of yoga, engage in a regular yoga practice. Design: EAT 2018 (Eating and Activity over Time) is a population-based study in which survey data were collected from 1568 ethnically/racially diverse (81.2% nonwhite) emerging young adults (mean age: 22.0 ± 2.0 years). Results: Exposure to adverse events was highly prevalent. For example, 43.9% reported at least one adverse childhood experience (ACE) (e.g., physical, emotional, or sexual abuse before age 18), whereas 40.1% reported experiencing discrimination. Exposure to adverse events was associated with higher stress levels. Practicing yoga at least 30 min/week was reported by 12.7% of the population, with variation across sociodemographic characteristics. Young adults exposed to adverse events were either more or similarly likely to practice yoga than young adults not reporting adverse events. Conclusions: The high prevalence of exposure to adverse events and associations with higher levels of stress points to a need for public health interventions. Thus, it was promising to find that young people exposed to adverse events, who may have greater emotional burdens, practice yoga at equal or greater proportions to those without these exposures. Given the potential benefits of yoga for populations living with high stress, it is important to develop further outreach efforts and provide accessible, acceptable, and affordable opportunities for practicing yoga.
A large-scale survey of adverse events experienced in yoga classes. [2022]Yoga is a representative mind-body therapy of complementary and alternative medicine. In Japan, yoga is practiced widely to promote health, but yoga-associated adverse events have also been reported. To date, the frequencies and characteristics of yoga-related adverse events have not been elucidated. This study was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
Health-related benefits and adverse events associated with yoga classes among participants that are healthy, in poor health, or with chronic diseases. [2021]Our previous study demonstrated that 42% of yoga class participants in Japan had chronic diseases requiring medication. This raises the question as to whether those with chronic diseases would benefit from practicing yoga or if they are at higher risk for specific adverse events compared to healthy individuals receiving the same instruction.
Getting Into Light Exercise (GENTLE-HF) for Patients With Heart Failure: the Design and Methodology of a Live-Video Group Exercise Study. [2023]Newer therapies have increased heart failure (HF) survival rates, but these therapies are rarely curative. The consequence of increased longevity is the likelihood that patients with HF will experience higher symptom burdens over time. Exercise such as cardiac rehabilitation programs can palliate symptom burdens, but numerous barriers prevent exercise participation and adherence. Small pilot studies indicate short-term beneficial effects of gentle forms of exercise such as yoga to address symptom burdens and accommodate comorbidities. Long-term symptom benefit and adherence to yoga are currently unknown. Therefore, a novel a home-based, gentle-stretching intervention that addresses issues of exercise access and adherence is described in this article.
Effects of Yoga in Patients with Chronic Heart Failure: A Meta-Analysis. [2021]The use of yoga as an effective cardiac rehabilitation in patients with chronic heart failure (CHF) remains controversial. We performed a meta-analysis to examine the effects of yoga on exercise capacity and health-related quality of life (HRQOL) in patients with CHF. Methods: We searched MEDLINE, Cochrane Central Register of Controlled Trials, Excerpta Medica database, LILACS, Physiotherapy Evidence Database, The Scientific Electronic Library Online, and Cumulative Index to Nursing and Allied Health (from the earliest date available to December 2013) for randomized controlled trials (RCTs) examining the effects of yoga versus exercise and/or of yoga versus control on exercise capacity (peakVO2) and quality-of-life (HRQOL) in CHF. Two reviewers selected studies independently. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated, and heterogeneity was assessed using the I2 test. Two studies met the selection criteria (total: 30 yoga and 29 control patients). The results suggested that yoga compared with control had a positive impact on peak VO2 and HRQOL. Peak VO2, WMD (3.87 95% CI: 1.95 to 5.80), and global HRQOL standardized mean differences (-12.46 95% CI: -22.49 to -2.43) improved in the yoga group compared to the control group. Yoga enhances peak VO2 and HRQOL in patients with CHF and could be considered for inclusion in cardiac rehabilitation programs. Larger RCTs are required to further investigate the effects of yoga in patients with CHF.
Effects of Hatha Yoga on Cardiac Hemodynamic Parameters and Physical Capacity in Cardiac Rehabilitation Patients. [2021]The purpose of the present study was to assess the effect of hatha yoga training that was added to the standard cardiac rehabilitation (CR) program on the cardiac hemodynamic parameters and physical capacity of patients with ST-elevation myocardial infarction (STEMI).
Enhancing the appeal of cardiac rehabilitation for women: development and pilot testing of a women-only yoga cardiac rehabilitation programme. [2022]Despite its demonstrated benefits, cardiac rehabilitation (CR) attendance, and completion is suboptimal, particularly in women. The aims of this study were (i) to develop and pilot test a women-only yoga-based CR programme (the Women's Yoga CR Programme; WYCRP); (ii) to investigate programme acceptability; and (iii) to investigate attendance and completion of the WYCRP and continuation to Phase III community-based CR.