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

NCT ID: NCT04511182

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-02-01

Brief Summary

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.

Detailed 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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

exercise intervention group

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.

Group Type: EXPERIMENTAL

Exercise-based cardiac rehabilitation

Intervention Type: BEHAVIORAL

Exercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination.

All patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months.

Usual care group（control）

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise-based cardiac rehabilitation

Exercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination.

All patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qin Shao, M.D,Ph.D

Role: STUDY_CHAIR

RenJi Hospital

Jun Ma, M.D,Ph.D

Role: STUDY_DIRECTOR

RenJi Hospital

Locations

RenJi Hospital, Shanghai JiaoTong University, School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Qin Shao, M.D,Ph.D

Role: CONTACT

shaoqindr@126.com

86-21-68385225

Jun Ma, M.D,Ph.D

Role: CONTACT

drjunma@126.com

86-21-68383164

Facility Contacts

Qin Shao, M.D,Ph.D

Role: primary

shaoqindr@126.com

86-21-68385225

Jun Ma, M.D,Ph.D

Role: backup

drjunma@126.com

86-21-68383164

Other Identifiers

CRP2

Identifier Type: -

Identifier Source: org_study_id