Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
Recruiting · NCT03180320 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- aged 18 years or above
- diagnosed with chronic heart failure
- clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month
- NYHA functional class II or III
Exclusion criteria
- patients who have contraindications to cardiopulmonary test
- patients who have contraindications to exercise training
- Patients who have serious acute or chronic organic disease or mental disorders
- history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months;
- history of cardiac arrest within 1 year;
- history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension;
- inability to perform a bicycle stress test;
- severe cognitive dysfunction precluding informed consent or understanding of exercise concepts;
- current regular Baduanjin or current participation in a conventional cardiac rehabilitation program
- current participation in another trial.
Where it is running
1 location listed.
- Guangdong Provincial Hospital of Chinese Medicine - Guangzhou, Guangdong, China