Yoga for Cardiovascular Disease

(SLYM II Trial)

Overseen By Yuliya Vengrenyuk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Congestive heart failure, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

120 Participants Needed

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?

Research shows that yoga can help reduce risk factors for heart disease, such as stress, anxiety, and depression, and improve quality of life. While yoga may not directly improve heart function, it can be a helpful addition to heart disease treatment by enhancing overall well-being. ^{1 2 3 4 5}

Is yoga safe for people with cardiovascular disease?

Research shows that yoga is generally safe, with no significant difference in serious or nonserious adverse events compared to usual care or exercise. However, there may be more minor adverse events compared to psychological or educational interventions. ^{1 6 7 8 9}

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. ^{1 10 11 12 13}

Research Team

Annapoorna Kini, MD

Principal Investigator

MOUNT SINAI HOSPITAL

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.

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.

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

Trial Overview The 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

Group I: Yoga Active Control 1 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 Care Active Control 1 Intervention

Control group patients will follow standard of care (SOC) treatment.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

A meta-analysis of 44 randomized controlled trials involving 3168 participants found that yoga significantly reduces key cardiovascular risk factors, including blood pressure, heart rate, waist circumference, and cholesterol levels, compared to usual care.

Despite some methodological concerns, the results suggest that yoga can be an effective complementary intervention for improving cardiovascular health in both the general population and high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of yoga on cardiovascular disease risk factors: a systematic review and meta-analysis. Cramer, H., Lauche, R., Haller, H., et al.[2022]

A systematic review of 7 randomized controlled trials involving 624 patients found very low evidence that yoga has no effect on mortality in patients with coronary heart disease, heart failure, and cardiac dysrhythmias, but it may reduce angina episodes and improve exercise capacity.

Despite the weak evidence for its effectiveness, yoga was reported to be safe, with no adverse events noted in the studies, leading to weak recommendations for its use as an ancillary intervention in heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of yoga for heart disease. Cramer, H., Lauche, R., Haller, H., et al.[2022]

A new yoga program tailored for post-myocardial infarction patients with left ventricular dysfunction was developed, incorporating exercises, breathing techniques, and meditation, and validated by experts in health and yoga.

The module showed good reliability and consistency, with a recommendation for 1 hour of supervised training for one month, suggesting it could be a beneficial addition to cardiac rehabilitation, pending further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a yoga module targeting cardiovascular health for patients with post-myocardial left ventricular dysfunction in India. Sharma, S., Pailoor, S., Choudhary Ram, N., et al.[2019]

The Tele-Yoga intervention was found to be acceptable and appropriate for individuals with heart failure and chronic obstructive pulmonary disease, with participants appreciating the home-based format and reporting enjoyment from the yoga sessions.

Despite some technological issues affecting video quality, the intervention showed potential benefits through physical postures, breathing exercises, and relaxation techniques, highlighting the need for further research to improve delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Selman, L., McDermott, K., Donesky, D., et al.[2022]

In a study involving 66 acute myocardial infarction patients, integrating yoga therapy into cardiac rehabilitation did not significantly improve left ventricular ejection fraction (LVEF) compared to standard care.

However, the yoga group experienced significant reductions in depression and anxiety levels, along with improvements in quality of life, suggesting that yoga can enhance mental well-being in CAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Yoga Practice in Cardiac Rehabilitation Program: A Randomized Control Trial. Sharma, KNS., Pailoor, S., Choudhary, NR., et al.[2021]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

A significant portion of young adults (43.9%) reported experiencing adverse childhood events, which were linked to higher stress levels, highlighting a critical public health concern.

Despite the challenges faced, 12.7% of the young adults practiced yoga for at least 30 minutes a week, with those exposed to adverse events practicing yoga at equal or greater rates than their peers, suggesting yoga could be a beneficial coping strategy for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Neumark-Sztainer, D., Wall, MM., Choi, J., et al.[2020]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

A study involving 328 first-time yoga practitioners showed that those with chronic diseases and poor health experienced significant improvements in mood, stress levels, and quality of life after three months of yoga practice, despite reporting more adverse events than healthy individuals.

Yoga classes, when conducted with attention to safety, can be beneficial for individuals with chronic diseases, leading to reduced symptoms like fatigue and insomnia, and overall satisfaction with the practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related benefits and adverse events associated with yoga classes among participants that are healthy, in poor health, or with chronic diseases. Oka, T., Lkhagvasuren, B.[2021]

The GENTLE-HF trial will evaluate a home-based gentle stretching and education intervention for heart failure patients, involving 234 participants, to see if it can reduce symptoms like dyspnea and improve quality of life over 26 weeks.

This study aims to address barriers to exercise participation and adherence, particularly in diverse populations, and will explore how living in rural areas may affect the relationship between exercise and symptom burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting Into Light Exercise (GENTLE-HF) for Patients With Heart Failure: the Design and Methodology of a Live-Video Group Exercise Study. Howie-Esquivel, J., Metzger, M., Malin, SK., et al.[2023]

A meta-analysis of two randomized controlled trials involving 30 patients practicing yoga and 29 control patients showed that yoga significantly improved exercise capacity (peak VO2) and health-related quality of life (HRQOL) in individuals with chronic heart failure (CHF).

The yoga group demonstrated a weighted mean difference of 3.87 in peak VO2 and a standardized mean difference of -12.46 in HRQOL compared to the control group, suggesting that yoga could be a beneficial addition to cardiac rehabilitation programs for CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Yoga in Patients with Chronic Heart Failure: A Meta-Analysis. Gomes-Neto, M., Rodrigues, ES., Silva, WM., et al.[2021]

In a study of 70 male patients aged 45-65 with ST-elevation myocardial infarction (STEMI), adding hatha yoga to standard cardiac rehabilitation significantly improved cardiac function and physical capacity compared to standard rehabilitation alone.

The experimental group showed notable enhancements in left ventricular ejection fraction (LVEF), peak oxygen uptake, and other echocardiographic parameters, suggesting that hatha yoga can be an effective adjunct therapy in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Hatha Yoga on Cardiac Hemodynamic Parameters and Physical Capacity in Cardiac Rehabilitation Patients. Grabara, M., Nowak, Z., Nowak, A.[2021]

The Women's Yoga Cardiac Rehabilitation Programme (WYCRP) was well-received by participants, with 81% attendance and positive feedback regarding its physical and emotional benefits.

The WYCRP significantly improved completion rates (95% vs. 56%) and continuation to community-based rehabilitation (72% vs. 12%) compared to the standard cardiac rehabilitation program, indicating its potential effectiveness for women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the appeal of cardiac rehabilitation for women: development and pilot testing of a women-only yoga cardiac rehabilitation programme. Murphy, BM., Zaman, S., Tucker, K., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of yoga on cardiovascular disease risk factors: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of yoga for heart disease. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

Development of a yoga module targeting cardiovascular health for patients with post-myocardial left ventricular dysfunction in India. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Integrated Yoga Practice in Cardiac Rehabilitation Program: A Randomized Control Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Health-related benefits and adverse events associated with yoga classes among participants that are healthy, in poor health, or with chronic diseases. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Getting Into Light Exercise (GENTLE-HF) for Patients With Heart Failure: the Design and Methodology of a Live-Video Group Exercise Study. [2023]

11. Brazil pubmed.ncbi.nlm.nih.gov

Effects of Yoga in Patients with Chronic Heart Failure: A Meta-Analysis. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of Hatha Yoga on Cardiac Hemodynamic Parameters and Physical Capacity in Cardiac Rehabilitation Patients. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Enhancing the appeal of cardiac rehabilitation for women: development and pilot testing of a women-only yoga cardiac rehabilitation programme. [2022]