NCT06404411尚未招募不适用
A Study of the Efficacy of Aerobic Exercise Based on Cardiopulmonary Exercise Test in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
Chengdu Sport University0 个研究点目标入组 40 人开始时间: 2024年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- VO2peak
研究概览
简要总结
A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 65 years;
- •A history of new coronavirus infection;
- •Patients with a clinical diagnosis of COVID-19-related myocardial injury;
- •In the late stages of recovery from COVID-19-related myocardial injury, at least 3 months after diagnosis;
- •Negative cardiopulmonary exercise test;
- •After completing respiratory rehabilitation at our hospital in the previous period;
- •Normal blood biomarker tests and essentially normal 2D-STE, normal left ventricular systolic function, no spontaneous or inducible arrhythmias on electrocardiographic monitoring, and the patient's clinical status is stable, with most of the symptoms in significant remission, and the daily still activities are intolerant or do not reach the pre-disease exercise level;
- •Classification of nyha heart function of class I or II;
- •Voluntarily sign the informed consent form;
- •Not participating in other clinical trials.
排除标准
- •a previous history of coronary atherosclerotic heart disease and heart failure;
- •a combination of severe arrhythmia or cardiogenic shock;
- •a combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or greater severity, acute myocarditis or pericarditis;
- •a combination of any disease that severely affects limb movement, such as musculoskeletal disorders or severe hepatic or renal insufficiency
- •a combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc;
- •those who have serious mental illness and are unable to cooperate
- •those with incomplete clinical data;
- •those who have dropped out or terminated the trial by themselves.
结局指标
主要结局
VO2peak
时间窗: 12 weeks
All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).
次要结局
- METpeak(12 weeks)
- BR(12 weeks)
- Six-minute walk test distance, 6MWD(12 weeks)
- SDANN(12 weeks)
- mental health composite scale，MCS(12 weeks)
- VEpeak(12 weeks)
- RMSSD(12 weeks)
- physical composite scale，PCS(12 weeks)
- AT(12 weeks)
- VO2/HRpeak(12 weeks)
- SDNN(12 weeks)
研究者
Ping Yang
Clinical Professor
Chengdu Sport University
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