Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
Conditions
Keywords
chronic heart failure, exercise-based cardiac rehabilitation, Baduanjin
Brief summary
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.
Interventions
BEHAVIORALBESMILE-HF program
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.
DRUGUsual medications
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Given the nature of the intervention, it is not possible to blind the patients and personnel involved in conducting the programs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline peak VO2 (ml/kg/min) at 12 week | Baseline, 12 week | Peak oxygen uptake |
| Change from baseline MLHFQ at 12 week | Baseline,12 week | Minnesota Living with Heart Failure Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GRC | Baseline, 4 week, 8 week, 12 week | Global Rating of Change |
| LVEF (%) | Baseline, 12 week | Parameters from echocardiography: Left ventricular systolic function |
| Global longitudinal strain 2D (%) | Baseline, 12 week | Parameters from echocardiography: Left ventricular systolic function |
| E/A ratio | Baseline, 12 week | Parameters from echocardiography: Left ventricular diastolic function |
| NT pro-BNP | Baseline, 12 week | Prognostic biomarker from blood sample |
| hsCRP | Baseline, 12 week | Inflammatory indicator from blood sample |
| Total score of Patient Health Questionnaire-9 (PHQ-9) | Baseline, 4 week, 8 week, 12 week | The total score ranges from 0-27, the higher scores indicates worse outcomes |
| Total score of General Anxiety Disorder-7 (GAD-7) | Baseline, 4 week, 8 week, 12 week | The total score ranges from 0-21, the higher scores indicates worse outcomes |
| Number of patients who has a increand 6% PeakVO2 | Baseline, 12 week | Number of patients who has a increand 6% PeakVO2 |
| 6MWT | Baseline, 4 week, 8 week, 12 week | 6-minute walking test |
| TGUG | Baseline, 4 week, 8 week, 12 week | Timed get-up and-go |
| SEE-C | Baseline, 4 week, 8 week, 12 week | Exercise Self-efficacy |
| MLHFQ | Baseline, 4 week, 8 week, 12 week | Minnesota Living with Heart Failure Questionnaire |
| EQ-5D | Baseline, 4 week, 8 week, 12 week | General quality of life |
| LVEDD (mm) | Baseline, 12 week | Parameters from echocardiography: Dimensions and volumes |
| LA (mm) | Baseline, 12 week | Parameters from echocardiography: Dimensions and volumes |
Other
| Measure | Time frame | Description |
|---|---|---|
| MACEs | Through study completion, an average of 12 weeks | Major acute cardiac events |
| SDANN Index | Baseline, 12 week | Parameters from Holter 24-hour ECG |
| SDNN Index | Baseline, 12 week | Parameters from Holter 24-hour ECG |
| All-caused mortality All-caused mortality | Through study completion, an average of 12 weeks | All-caused mortality |
| All-caused hospitalization | Through study completion, an average of 12 weeks | All-caused hospitalization |
| Adverse events | Through study completion, an average of 12 weeks | Safety assessment |
| IPAQ | Baseline, 4 week, 8 week, 12 week | International Physical Activity Questionnaire |
| Heart failure hospitalizaiton | Through study completion, an average of 12 weeks | Heart failure hospitalizaiton |
Countries
China
Contacts
Primary ContactWeihui Lu
Backup ContactXiankun Chen
Outcome results
None listed