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Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with high mortality. After a long period of medical treatment or surgical treatment, patients suffered great pain physically and mentally. How to improve the quality of life and prognosis in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for CHF patients.
To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart disease complicated with chronic heart failure (CHF). A randomized, controlled and prospective clinical trial was designed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baduanjin exercise group | Experimental | Participants in this group received routine rehabilitation training and Baduanjin exercise |
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| Routine rehabilitation group | Active Comparator | Participants in this group only received routine rehabilitation training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baduanjin exercise | Behavioral | Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test(6MWT) | Testing patients changes on walking distance and accompanies symptoms in 6 minutes | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary exercise test (CPET) | CPET including peak VO2 (ml/kg/min), AT,VE/VCO2, et,al. | Baseline, 3 months |
| Left ventricular ejection fraction(LVEF) | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meili Yu | Contact | +86(010)62835341 | woshananyang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hao Xu | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30012193 | Derived | Yu M, Li S, Li S, Li J, Xu H, Chen K. Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial. Trials. 2018 Jul 16;19(1):381. doi: 10.1186/s13063-018-2759-4. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Routine rehabilitation group | Behavioral | Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day,twice per week, lasts 12 weeks. |
|
| Left ventricular end-diastolic diameter (LVDD) | Baseline, 3 months |
| Minnesota living with heart failure questionnaire (MLHFQ) | Record the quality of life of patients with heart failure | Baseline, 3 months |
| NT-proBNP | Baseline, 3 months |
| hs-CRP | Baseline, 3 months |
| HRV | Mainly includes SDANN Index, SDNN Index | Baseline, 3 months |
| Major adverse cardiovascular events (MACE) | Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease | Baseline, 3 months, 6months |
| NYHA classification | The changes of heart function were compared after treatment | Baseline, 3 months, 6months |
| The Main TCM symptoms | The changes of scores of TCM syndromes | Baseline, 3 months |