Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Myocardial Infarction
- Sponsor
- RenJi Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Peak oxygen consumption (VO2)change
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Peak oxygen consumption (VO2)change
Time Frame: Baseline, 3, 6 months
Difference in the interval changes from baseline to 3 months and 6 months in peak VO2 comparing Experimental group with control.
Secondary Outcomes
- oxygen consumption (VO2) at anaerobic threshold(Baseline, 3, 6 months)
- Peak metabolic equivalent (MET) change(Baseline, 3, 6 months)
- The MOS item short form health survey(SF-36)(Baseline, 3, 6 months)
- Ventilatory efficiency (VE/VCO2 slope) change(Baseline, 3, 6 months)
- Body mass index（BMI）change(Baseline, 3, 6 months)
- LVEF change(Baseline, 3, 6 months)
- Oxygen uptake related to work rate（ΔVO2/ΔWR）change(Baseline, 3, 6 months)
- Peak /AT Oxygen Pulse (O2-Pulse)change(Baseline, 3, 6 months)
- Heart rate variability(Baseline, 3, 6 months)
- NT-proBNP(pg/ml)(Baseline, 3, 6 months)
- The occurrence and composite of major adverse cardiac events (MACE)(3, 6 months)