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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGChange from baseline peak VO2 (ml/kg/min) at 12 week
Peak oxygen uptake
Time frame: Baseline, 12 week
Change from baseline MLHFQ at 12 week
Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline,12 week
6MWT
6-minute walking test
Time frame: Baseline, 4 week, 8 week, 12 week
TGUG
Timed get-up and-go
Time frame: Baseline, 4 week, 8 week, 12 week
SEE-C
Exercise Self-efficacy
Time frame: Baseline, 4 week, 8 week, 12 week
MLHFQ
Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline, 4 week, 8 week, 12 week
EQ-5D
General quality of life
Time frame: Baseline, 4 week, 8 week, 12 week
GRC
Global Rating of Change
Time frame: Baseline, 4 week, 8 week, 12 week
LVEDD (mm)
Parameters from echocardiography: Dimensions and volumes
Time frame: Baseline, 12 week
LA (mm)
Parameters from echocardiography: Dimensions and volumes
Time frame: Baseline, 12 week
LVEF (%)
Parameters from echocardiography: Left ventricular systolic function
Time frame: Baseline, 12 week
Global longitudinal strain 2D (%)
Parameters from echocardiography: Left ventricular systolic function
Time frame: Baseline, 12 week
E/A ratio
Parameters from echocardiography: Left ventricular diastolic function
Time frame: Baseline, 12 week
NT pro-BNP
Prognostic biomarker from blood sample
Time frame: Baseline, 12 week
hsCRP
Inflammatory indicator from blood sample
Time frame: Baseline, 12 week
Total score of Patient Health Questionnaire-9 (PHQ-9)
The total score ranges from 0-27, the higher scores indicates worse outcomes
Time frame: Baseline, 4 week, 8 week, 12 week
Total score of General Anxiety Disorder-7 (GAD-7)
The total score ranges from 0-21, the higher scores indicates worse outcomes
Time frame: Baseline, 4 week, 8 week, 12 week
Number of patients who has a increand 6% PeakVO2
Number of patients who has a increand 6% PeakVO2
Time frame: Baseline, 12 week
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