Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction

Shanghai Jiao Tong University

Status: Unknown

Conditions: Acute Myocardial Infarction

Treatments: Behavioral: Exercise-based cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04511182

CRP2

Details and patient eligibility

About

Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability. After reperfusion therapies and pharmacological strategies, patients suffered great pain physically and mentally. How to improve the quality of life and the prognosis in patients with AMI is a hot topic in the field of cardiac rehabilitation now. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET). Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.

Full description

Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability, although reperfusion therapies and pharmacological strategies have been developed dramatically. Percutaneous coronary intervention（PCI）can effectively improve the myocardial blood supply of patients, However, various degrees of reduced exercise tolerance, anxiety and depression symptoms, impaired social function may occur after PCI and then lead to the decline of their quality of life. Exercise-based cardiopulmonary rehabilitation, which has beneficial effects on physical fitness, quality of life, cardiovascular risk factors and clinical outcome, is an important part of secondary prevention for patients after an acute myocardial infarction. Despite the evidence of these beneficial effects, cardiac rehabilitation programs are still largely underutilized and the exact benefits are still less well known. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET) . Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Acute myocardial infarction (AMI) within 1 months prior to recruitment.
2. Complete revascularization.
3. Man or non- pregnant women aged from 18 to 80 years.

Exclusion criteria

1. Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure >160/100 mmHg)，or symptomatic hypotension.
2. Significant resting electrocardiogram abnormalities (left bundle branch block, non-specific intraventricular conduction delay, left ventricular hypertrophy, resting ST-segment depression), life-threatening cardiac arrhythmias.
3. Acute myocarditis, pericarditis or acute systemic illness.
4. Those who are assessed by the doctor as high-risk [12].
5. Pacemaker or implantable cardioverter defibrillator.
6. Any contraindication to exercise testing or exercise training or inability to complete a CPET.
7. Life-threatening diseases with limited life expectancy <3 year.
8. Uncontrolled unstable angina pectoris.
9. Significant valvular disease (mitral stenosis, moderate to severe mitral insufficiency, aortic stenosis, or aortic insufficiency, severe mitral / aortic regurgitation).
10. Severe mental or cognitive impairment.
11. Inability to follow the procedures of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

exercise intervention group

Experimental group

Description:

Patients will receive standard medications plus EBCR 。Education covering topics related to AMI and exercise for AMI will be implemented and any consultations on exercise prescription and disease management will be explained by a cardiac rehabilitation team consisting of cardiologists, cardiology nurses and physiotherapists.

Treatment:

Behavioral: Exercise-based cardiac rehabilitation

Usual care group（control）

No Intervention group

Description:

Patients will receive standard medications according to national guidelines, as well as education and consultations as intervention group. However，no exercise prescription is given,