About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
BESMILE-HF program
BehavioralThe 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
DrugThroughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline peak VO2 (ml/kg/min) at 12 week
Peak oxygen uptake
Change from baseline MLHFQ at 12 week
Minnesota Living with Heart Failure Questionnaire
Secondary outcomes
6MWT
6-minute walking test
TGUG
Timed get-up and-go
SEE-C
Exercise Self-efficacy
MLHFQ
Minnesota Living with Heart Failure Questionnaire
Other outcomes
IPAQ
International Physical Activity Questionnaire
Adverse events
Safety assessment
MACEs
Major acute cardiac events
SDANN Index
Parameters from Holter 24-hour ECG
Sponsors and contacts
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