Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)

NCT03180320 · tracked via the Priya Life Science China tracker

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Phase

Not applicable

Started

2018-10-22

Last updated

2025-05-18

Condition(s) studied

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure

Investigational drug(s) / intervention(s)

BESMILE-HF programUsual medications

BESMILE-HF program: The following activities will be conducted as part of the BESMILE-HF program: 1. Baduanjin exercise; 2. evaluations of exercise capacity and clinical conditions; 3. consultations on exercise prescription and management of symptoms/signs during exercise; 4. education covering topics related to the CHF and exercise; and 5. a series of adherence strategies.

Usual medications: Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.

Study summary

Chronic heart failure (CHF) is a major and growing public health problem and poses economic burden on the society. There is a need for a safe, equipment-free, low-cost, and easily implemented exercise-based cardiac rehabilitation program for CHF patients in China. Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms of traditional Chinese exercise and it could have value to be integrated into a exercise-based cardiac rehabilitation program for CHF patients, together with education, evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin exercise as the central component, has been developed in Guangdong Provincial Hospital of Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with CHF in China, and it will be based on a randomized controlled trial and a qualitative study.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline peak VO2 (ml/kg/min) at 12 week — Baseline, 12 week
Peak oxygen uptake
Change from baseline MLHFQ at 12 week — Baseline,12 week
Minnesota Living with Heart Failure Questionnaire

Trial sites (1)

Facility	City	Region	Status
Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03180320 on ClinicalTrials.gov ↗ ← All trials in China