NCT04511182

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

Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-08-01
• Completion: 2023-02-01
• First posted: 2020-08-13
• Last updated: 2021-02-05

Locations

1 site across 1 country: China