Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Peak oxygen consumption (VO2)change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Peak oxygen consumption (VO2)change
时间窗: 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.
次要结局
- 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)
