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

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Enrolling

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure

Treatments: Behavioral: BESMILE-HF program; Drug: Usual medications

Study type: Interventional

Funder types: Other

Identifiers

NCT03180320

B2016-202-01

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

BESMILE-HF group

Experimental group

Description:

Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. In addition, patients will receive the BESMILE-HF program.

Treatment:

Drug: Usual medications

Behavioral: BESMILE-HF program

Control

Other group

Description:

Patients in the control group will receive only the usual medications, since patients typically do not receive exercise-based cardiac rehabilitation in this kind of setting.

Treatment:

Drug: Usual medications