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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BESMILE-HF group | Experimental | 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. |
|
| Control | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BESMILE-HF program | Behavioral | The following activities will be conducted as part of the BESMILE-HF program:
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| IPAQ | International Physical Activity Questionnaire | Baseline, 4 week, 8 week, 12 week |
| Adverse events | Safety assessment | Through study completion, an average of 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weihui Lu | Contact | +86(020)81887233 | 35837 | weihui.lu@163.com |
| Xiankun Chen | Contact | +86(020)81887233 | 35837 | chenxiankun232323@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Weihui Lu | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Gaetano Marrone | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36894879 | Derived | Sun P, Cen H, Chen S, Chen X, Jiang W, Zhu H, Liu Y, Liu H, Lu W. Left atrial dysfunction can independently predict exercise capacity in patients with chronic heart failure who use beta-blockers. BMC Cardiovasc Disord. 2023 Mar 9;23(1):128. doi: 10.1186/s12872-023-03127-9. | |
| 34386535 | Derived | Chen X, Jiang W, Olson TP, Lundborg CS, Wen Z, Lu W, Marrone G. Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial. Front Cardiovasc Med. 2021 Jul 27;8:715207. doi: 10.3389/fcvm.2021.715207. eCollection 2021. |
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Given the nature of the intervention, it is not possible to blind the patients and personnel involved in conducting the programs.
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|
| Usual medications | Drug | Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. |
|
| 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 |
| MACEs | Major acute cardiac events | Through study completion, an average of 12 weeks |
| SDANN Index | Parameters from Holter 24-hour ECG | Baseline, 12 week |
| SDNN Index | Parameters from Holter 24-hour ECG | Baseline, 12 week |
| All-caused mortality All-caused mortality | All-caused mortality | Through study completion, an average of 12 weeks |
| All-caused hospitalization | All-caused hospitalization | Through study completion, an average of 12 weeks |
| Heart failure hospitalizaiton | Heart failure hospitalizaiton | Through study completion, an average of 12 weeks |
| Wei Jiang |
| Guangdong Provincial Hospital of Traditional Chinese Medicine |
| Principal Investigator |
| Zehuai Wen | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| 29490680 | Derived | Chen X, Jiang W, Lin X, Lundborg CS, Wen Z, Lu W, Marrone G. Effect of an exercise-based cardiac rehabilitation program "Baduanjin Eight-Silken-Movements with self-efficacy building" for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):150. doi: 10.1186/s13063-018-2531-9. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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