Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6, Canada
NCT Number: NCT05035628
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.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H1T1N6, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will follow a 2-month exercise training program, thrice-weekly trainings. The training sessions will start with a 5-min warmup, followed by an aerobic training (20 min) after which 20-min of resistance/muscular training will take place. The program will end with respiratory exercises and cool down period (10 min). Training will be adapted to individuals' baseline capacity as measured by the baseline cardiorespiratory test.
A certified kinesiologist will supervise trainings. Heart rate, oxygen saturation and rating of perceived exertion (Borg Scale, 6-20) will be measured during training sessions.
Time frame: Baseline and post-intervention at 2 months
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)
Time frame: Baseline and post-intervention at 2 months
maximum distance performed in 6 minutes (distance, m)
Time frame: Baseline and post-intervention at 2 months
Timed up and Go test (s).
Time frame: Baseline and post-intervention at 2 months
Timed Sit-to-Stand test (s).
Time frame: 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).
Time frame: Baseline and post-intervention at 2 months
State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and post-intervention at 2 months
forced expiratory volume in 1 second (L.)
Time frame: Baseline and post-intervention at 2 months
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Time frame: Baseline and post-intervention at 2 months
Validated remote version of neuropsychological tests (Z-score)
Time frame: Baseline and post-intervention at 2 months
Validated remote version of neuropsychological tests (Z-score)
Time frame: Baseline and post-intervention at 2 months
Validated remote version of neuropsychological tests (Z-score)
Time frame: Baseline and post-intervention at 2 months
C-reactive protein (mg/L/L)
Time frame: Baseline and post-intervention at 2 months
serum levels of uric acid (mg/dL), albumin (g/L)
Time frame: Baseline and post-intervention at 2 months
fibrinogen (g/L)
Time frame: 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.
Time frame: 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.
Louis Bherer
Other
Acronym: COVID-Rehab
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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