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临床试验/NCT04511182
NCT04511182Unknown不适用

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

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年2月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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