Cardiopulmonary Rehabilitation in Long COVID-19 Patients With Persistent Breathlessness and Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in cardiorespiratory fitness
研究概览
简要总结
The objective of this project is to assess the effects of a 2-month cardiopulmonary rehabilitation program on cardiorespiratory fitness in long COVID19 patients. Quality of life, functional capacity, functional respiratory capacity, inflammatory profile, coagulation markers, cognitive functions and brain O2 saturation will also be assessed before and after the exercise rehabilitation program.
详细描述
Some symptoms such as breathlessness and fatigue appear to persist for several months after COVID-19 infection in about 50% of cases. Stress, anxiety, neurological and cognitive disorders have also been reported in the long-term side effects associated with the disease. Cardiopulmonary rehabilitation programs are recognized as an essential component of the management of people with chronic respiratory disease. These programs are based on exercise training with aerobic exercises, muscle strengthening, breathing exercises. Beyond the benefit on morbi-mortality, a marked improvement in symptoms, fitness and quality of life is observed in chronic respiratory diseases. Several hospital departments, research teams and scientific organizations as the WHO recommend the use of rehabilitation programs for COVID-19 patients.
The main objective is to assess the effects of a 2-month cardiopulmonary rehabilitation program on cardiorespiratory fitness in long COVID19 patients. Secondary objectives include: to characterize baseline and intervention-related changes in quality of life, functional capacity, functional respiratory capacity, inflammatory profile, coagulation markers, cognitive functions, neurovascular coupling and cortical pulsatility.
All participants will have signed a written consent form before taking part in the study.
40 patients who have had COVID-19 with persistent breathlessness and fatigue symptoms after at least 3 months after the diagnosis will be randomly assigned to one of the 2 following study arms : 1/ cardiopulmonary exercise training program; 2/ control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
This clinical trial is a single-blinded study. Research personnel performing the outcome assessments and investigators will be blinded to group allocation.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 40 and 80
- •Individuals infected by the SARS-COV2 virus, with positive PCR diagnosis
- •Still having breathlessness and fatigue at least 3 months after the diagnosis of COVID-19 or patients presenting an increase of 1 point (compared to before infection) on the Modified Medical Research Council scale.
- •Able to perform a maximal cardiopulmonary stress test and exercise training program in accordance with current guidelines on cardiopulmonary rehabilitation.
- •Able to read, understand and sign the information and consent form.
排除标准
- •pulmonary embolism diagnosed by scintigraphy
- •Absolute and relative contraindication to exercise stress test and / or exercise training
- •Recent cardiovascular events (cardiac decompensation or angioplasty or cardiac surgery, less than 1 month; valvular disease requiring surgical correction, active myopericarditis, severe ventricular arrhythmias not stabilized under treatment).
- •Kidney failure requiring dialysis
- •heart failure (NYHA III or IV)
结局指标
主要结局
Change in cardiorespiratory fitness
时间窗: Baseline and post-intervention at 2 months
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)
次要结局
- Change in processing speed(Baseline and post-intervention at 2 months)
- Change in Functional mobility(Baseline and post-intervention at 2 months)
- Change in functional respiratory capacity(Baseline and post-intervention at 2 months)
- Change in general cognitive functioning(Baseline and post-intervention at 2 months)
- Change in episodic memory(Baseline and post-intervention at 2 months)
- Change in markers of coagulation(Baseline and post-intervention at 2 months)
- Change in Quality-of-life(Baseline and post-intervention at 2 months)
- Change in 6-min walking test performance(Baseline and post-intervention at 2 months)
- Change in Sleep quality(Baseline and post-intervention at 2 months)
- Change in Lower limb muscles strength(Baseline and post-intervention at 2 months)
- Change in oxidative stress(Baseline and post-intervention at 2 months)
- Change in cerebral pulsatility - cortical frontal region(Baseline and post-intervention at 2 months)
- Change in executive functions(Baseline and post-intervention at 2 months)
- Change in neurovascular coupling(Baseline and post-intervention at 2 months)
- Change in inflammatory profile(Baseline and post-intervention at 2 months)
- Change in Anxiety(Baseline and post-intervention at 2 months)
研究者
Louis Bherer
Associate scientific director, Direction of prevention, Montreal Heart Institute
Montreal Heart Institute