Baduanjin exercise program for chronic heart failure patients
Effect of an Exercise-based Cardiac Rehabilitation Program 'Baduanjin-eight-silken-movement With Self-efficacy Building' for Patients With Chronic Heart Failure in Guangzhou, China (BESMILE-HF Study)
This study tests whether a traditional Chinese exercise program can help people with chronic heart failure feel better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03180320 on ClinicalTrials.gov |
What this trial studies
This program integrates Baduanjin, a traditional Chinese exercise, into a cardiac rehabilitation framework for patients with chronic heart failure. It aims to provide a safe, low-cost, and equipment-free exercise option, along with education and support. The BESMILE-HF program will be evaluated through a randomized controlled trial and qualitative assessments to determine its efficacy and acceptability among patients in China. The study focuses on patients classified as NYHA Class II or III, who are clinically stable.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with chronic heart failure, specifically those in NYHA functional class II or III.
Not a fit: Patients with serious acute or chronic organic diseases, mental disorders, or those who cannot participate in exercise training may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could enhance the quality of life and physical function for patients with chronic heart failure.
How similar studies have performed: While the integration of traditional exercises like Baduanjin into cardiac rehabilitation is innovative, similar approaches have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged 18 years or above 2. diagnosed with chronic heart failure 3. clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month 4. NYHA functional class II or III Exclusion Criteria: 1. patients who have contraindications to cardiopulmonary test 2. patients who have contraindications to exercise training 3. Patients who have serious acute or chronic organic disease or mental disorders 4. history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months; 5. history of cardiac arrest within 1 year; 6. history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension; 7. inability to perform a bicycle stress test; 8. severe cognitive dysfunction precluding informed consent or understanding of exercise concepts; 9. current regular Baduanjin or current participation in a conventional cardiac rehabilitation program 10. current participation in another trial.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Weihui Lu — Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study coordinator: Weihui Lu
- Email: weihui.lu@163.com
- Phone: +86(020)81887233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.