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Cardiac rehabilitation (CR), particularly regular exercise, can improve the cardiopulmonary function, exercise capacity, and quality of life for patients undergoing transcatheter aortic valve implantation (TAVI). Consequently, the patients after TAVI will be enrolled in our randomized controlled trial to demonstrate if the moderate-intensity continuous training (MICT) can improve the cardiopulmonary function compared with the control group after receiving treatment for 12 weeks. Moreover, we will provide new insights regarding whether cardiac systolic function or cardiac diastolic function is mainly improved after regular exercise for TAVI patients. As a result, the principal hypothesis of our study is that MICT will improve the cardiopulmonary function and can extremely affect the cardiac diastolic function of patients with TAVI after the implementation of exercise for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate intensity continuous training | Experimental |
| |
| guideline control | No Intervention | Patients assigned to the guideline control just received 1-time advice on training according to guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moderate intensity continuous training | Behavioral | Moderate intensity continuous training was scheduled 3 times per week for 3 months. Every sessions included warm-up (<50% target intensity for 2 min then gradually increasing load 1-10 W/min up to 100% target intensity for 5-10 min), exercise phase (100% target intensity (heart rate at anaerobic threshold±5) starting with 20 min and gradually lengthening up to 45 min in the 1 month as well as 45 min in another 2 months), cool down with gradual reduction of load within 3 min. The target intensity will be determined by the heart rate at anaerobic threshold measured by cardiopulmonary exercise test (CPET). The intensity will be adjusted after implementation of CPET and will keep at a minimum intensity, gradually increasing to the maximum intensity every month. Moreover, patients will be instructed to complete 2 supervised sessions and 1 home-based session during the 1 month and then to continue 3 home-based session for a further 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| change in peak oxygen uptake (peak VO2) after 3 months | 3 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 6-min walk distance | 3 months and 1 year | |
| the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12) | 3 months and 1 year | |
| New York Heart Association class (NYHA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ya-Ling Han, PhD | Contact | +862428897309 | hanyaling@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Ya-Ling Han, PhD | Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ya-Ling Han | Recruiting | Shenyang | Liaoning | 110016 | China |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
The NYHA is measured by Classification of NYHA heart function |
| 3 months and 1 year |
| E/e' | it is measured by echocardiography | 3 months and 1 year |
| E/A | it is measured by echocardiography | 3 months and 1 year |
| left atrial volume index(LAVI) | it is measured by echocardiography | 3 months and 1 year |
| left ventricular ejection fraction(LV-EF) | it is measured by echocardiography | 3 months and 1 year |
| mean pressure gradient(PGmean) | it is measured by echocardiography | 3 months and 1 year |
| maximal pressure gradient (PGmax) | it is measured by echocardiography | 3 months and 1 year |
| maximal velocity(Vmax) | it is measured by echocardiography | 3 months and 1 year |
| valve orifice area | it is measured by echocardiography | 3 months and 1 year |
| N-terminal pro-brain natriuretic peptide (NT-proBNP) | 3 months and 1 year |
| C-reactive protein(CRP) | 3 months and 1 year |
| hemoglobin | 3 months and 1 year |
| cholesterol | 3 months and 1 year |
| triglyceride | 3 months and 1 year |
| high density lipoprotein (HDL) | 3 months and 1 year |
| low density lipoprotein (LDL) | 3 months and 1 year |
| Major adverse cardiovascular events | Major adverse cardiovascular events is a composite endpoint of death, stroke, revascularization, and myocardial infarction. | 3 months and 1 year |
| change in peak oxygen uptake (peak VO2) after 1 year | 1 year |