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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of an Exercise-based Cardiac Rehabilitation Program 'Baduanjin-eight-silken-movement With Self-efficacy Building' for Patients With Chronic Heart Failure in Guangzhou, China (BESMILE-HF Study)

Conditions
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Heart Failure NYHA Class II, Heart Failure NYHA Class III

Intervention / Treatment
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* Behavioral: BESMILE-HF program
* Drug: Usual medications


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BESMILE-HF group<br>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. | Behavioral: BESMILE-HF program<br>* The following activities will be conducted as part of the BESMILE-HF program: Baduanjin exercise; evaluations of exercise capacity and clinical conditions; consultations on exercise prescription and management of symptoms/signs during exercise; education covering topics related to the CHF and exercise; and a series of adherence strategies.<br>Drug: Usual medications<br>* Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.<br>|
| Other: Control<br>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. | Drug: Usual medications<br>* Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline peak VO2 (ml/kg/min) at 12 week | Peak oxygen uptake | Baseline, 12 week | 
| Change from baseline MLHFQ at 12 week | Minnesota Living with Heart Failure Questionnaire | Baseline,12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | 6-minute walking test | Baseline, 4 week, 8 week, 12 week | 
| TGUG | Timed get-up and-go | Baseline, 4 week, 8 week, 12 week | 
| SEE-C | Exercise Self-efficacy | Baseline, 4 week, 8 week, 12 week | 
| MLHFQ | Minnesota Living with Heart Failure Questionnaire | Baseline, 4 week, 8 week, 12 week | 
| EQ-5D | General quality of life | Baseline, 4 week, 8 week, 12 week | 
| GRC | Global Rating of Change | Baseline, 4 week, 8 week, 12 week | 
| LVEDD (mm) | Parameters from echocardiography: Dimensions and volumes | Baseline, 12 week | 
| LA (mm) | Parameters from echocardiography: Dimensions and volumes | Baseline, 12 week | 
| LVEF (%) | Parameters from echocardiography: Left ventricular systolic function | Baseline, 12 week | 
| Global longitudinal strain 2D (%) | Parameters from echocardiography: Left ventricular systolic function | Baseline, 12 week | 
| E/A ratio | Parameters from echocardiography: Left ventricular diastolic function | Baseline, 12 week | 
| NT pro-BNP | Prognostic biomarker from blood sample | Baseline, 12 week | 
| hsCRP | Inflammatory indicator from blood sample | 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 | 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 | 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 | Baseline, 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, exercise-based cardiac rehabilitation, Baduanjin