Cardiopulmonary Rehabilitation in Long COVID-19 Patients With Persistent Breathlessness and Fatigue
- Conditions
- COVID-19 Respiratory Infection
- Interventions
- Other: Cardiopulmonary exercise training
- Registration Number
- NCT05035628
- Lead Sponsor
- Louis Bherer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiopulmonary exercise training group Cardiopulmonary exercise training Cardiopulmonary exercise intervention will include aerobic exercise, resistance and respiratory exercises, three sessions per week for 2 months
- Primary Outcome Measures
Name Time Method Change in cardiorespiratory fitness Baseline and post-intervention at 2 months Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)
- Secondary Outcome Measures
Name Time Method Change in Functional mobility Baseline and post-intervention at 2 months Timed up and Go test (s).
Change in functional respiratory capacity Baseline and post-intervention at 2 months forced expiratory volume in 1 second (L.)
Change in general cognitive functioning Baseline and post-intervention at 2 months Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Change in processing speed Baseline and post-intervention at 2 months Validated remote version of neuropsychological tests (Z-score)
Change in episodic memory Baseline and post-intervention at 2 months Validated remote version of neuropsychological tests (Z-score)
Change in markers of coagulation Baseline and post-intervention at 2 months fibrinogen (g/L)
Change in Quality-of-life Baseline and post-intervention at 2 months 36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).
Change in 6-min walking test performance Baseline and post-intervention at 2 months maximum distance performed in 6 minutes (distance, m)
Change in Anxiety Baseline and post-intervention at 2 months Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).
Change in Sleep quality Baseline and post-intervention at 2 months Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). severe).
Change in Lower limb muscles strength Baseline and post-intervention at 2 months Timed Sit-to-Stand test (s).
Change in oxidative stress Baseline and post-intervention at 2 months serum levels of uric acid (mg/dL), albumin (g/L)
Change in cerebral pulsatility - cortical frontal region Baseline and post-intervention at 2 months Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.
Change in executive functions Baseline and post-intervention at 2 months Validated remote version of neuropsychological tests (Z-score)
Change in neurovascular coupling Baseline and post-intervention at 2 months Changes in brain activity evoked by a N-back task and walking relative to baseline will be assessed by t-statistics maps, computed from variations of \[HbO\] and \[HbR\] measured by NIRS at the prefrontal cortex.
Change in inflammatory profile Baseline and post-intervention at 2 months C-reactive protein (mg/L/L)
Trial Locations
- Locations (1)
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada