Heart Failure NYHA Class III Clinical Trial
— BESMILE-HFOfficial title:
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)
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial Hospital of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | IPAQ | International Physical Activity Questionnaire | Baseline, 4 week, 8 week, 12 week | |
Other | Adverse events | Safety assessment | Through study completion, an average of 12 weeks | |
Other | MACEs | Major acute cardiac events | Through study completion, an average of 12 weeks | |
Other | SDANN Index | Parameters from Holter 24-hour ECG | Baseline, 12 week | |
Other | SDNN Index | Parameters from Holter 24-hour ECG | Baseline, 12 week | |
Other | All-caused mortality All-caused mortality | All-caused mortality | Through study completion, an average of 12 weeks | |
Other | All-caused hospitalization | All-caused hospitalization | Through study completion, an average of 12 weeks | |
Other | Heart failure hospitalizaiton | Heart failure hospitalizaiton | Through study completion, an average of 12 weeks | |
Primary | Change from baseline peak VO2 (ml/kg/min) at 12 week | Peak oxygen uptake | Baseline, 12 week | |
Primary | Change from baseline MLHFQ at 12 week | Minnesota Living with Heart Failure Questionnaire | Baseline,12 week | |
Secondary | 6MWT | 6-minute walking test | Baseline, 4 week, 8 week, 12 week | |
Secondary | TGUG | Timed get-up and-go | Baseline, 4 week, 8 week, 12 week | |
Secondary | SEE-C | Exercise Self-efficacy | Baseline, 4 week, 8 week, 12 week | |
Secondary | MLHFQ | Minnesota Living with Heart Failure Questionnaire | Baseline, 4 week, 8 week, 12 week | |
Secondary | EQ-5D | General quality of life | Baseline, 4 week, 8 week, 12 week | |
Secondary | GRC | Global Rating of Change | Baseline, 4 week, 8 week, 12 week | |
Secondary | LVEDD (mm) | Parameters from echocardiography: Dimensions and volumes | Baseline, 12 week | |
Secondary | LA (mm) | Parameters from echocardiography: Dimensions and volumes | Baseline, 12 week | |
Secondary | LVEF (%) | Parameters from echocardiography: Left ventricular systolic function | Baseline, 12 week | |
Secondary | Global longitudinal strain 2D (%) | Parameters from echocardiography: Left ventricular systolic function | Baseline, 12 week | |
Secondary | E/A ratio | Parameters from echocardiography: Left ventricular diastolic function | Baseline, 12 week | |
Secondary | NT pro-BNP | Prognostic biomarker from blood sample | Baseline, 12 week | |
Secondary | hsCRP | Inflammatory indicator from blood sample | Baseline, 12 week | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Number of patients who has a increand 6% PeakVO2 | Number of patients who has a increand 6% PeakVO2 | Baseline, 12 week |
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