Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction
- Conditions
- Acute Myocardial Infarction
- Interventions
- Behavioral: Exercise-based cardiac rehabilitation
- Registration Number
- NCT04511182
- Lead Sponsor
- RenJi Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exercise intervention group Exercise-based cardiac rehabilitation 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.
- Primary Outcome Measures
Name Time Method Peak oxygen consumption (VO2)change 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 Outcome Measures
Name Time Method oxygen consumption (VO2) at anaerobic threshold Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in VO2 at anaerobic threshold comparing Experimental group with control.
Peak metabolic equivalent (MET) change Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in peak metabolic equivalent (MET) change comparing experimental group with control.
The MOS item short form health survey(SF-36) Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in The MOS item short form health survey(SF-36) comparing experimental group with control.
Ventilatory efficiency (VE/VCO2 slope) change Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in Ventilatory efficiency (VE/VCO2 slope) comparing experimental group with control.
Body mass index（BMI）change Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in Body mass index（BMI）comparing experimental group with control. BMI is the value obtained by dividing body weight by height square (weight in kilograms, height in meters). BMI is a standard commonly used in the world to measure the degree of obesity and health of the human body.
LVEF change Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in LVEF comparing experimental group with control.
Oxygen uptake related to work rate（ΔVO2/ΔWR）change Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in Oeygen uptake related to work rate（ΔVO2/ΔWR）comparing experimental group with control.
Peak /AT Oxygen Pulse (O2-Pulse)change Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in Peak /AT Oxygen Pulse (O2-Pulse) comparing experimental group with control.
Heart rate variability Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in Heart rate variability comparing experimental group with control.
NT-proBNP(pg/ml) Baseline, 3, 6 months Difference in the interval changes from baseline to 3 months and 6 months in NT-proBNP comparing Experimental group with control.
The occurrence and composite of major adverse cardiac events (MACE) 3, 6 months Major adverse cardiac events (MACE) included all-cause mortality, non-fatal myocardial infarction and coronary revascularisation. we check the outcome in 3 months and 6 months.
Trial Locations
- Locations (1)
RenJi Hospital, Shanghai JiaoTong University, School of Medicine
🇨🇳Shanghai, Shanghai, China