COVID-Rehab: Cardiopulmonary Rehabilitation in Long COVID-19 Patients With Persistent Breathlessness and Fatigue

Sponsor

Louis Bherer (Other)

Overall Status

Recruiting

CT.gov ID

NCT05035628

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection	Other: Cardiopulmonary exercise training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel assignement with 2 groups (1:1)parallel assignement with 2 groups (1:1)

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

This clinical trial is a single-blinded study. Research personnel performing the outcome assessments and investigators will be blinded to group allocation.

Primary Purpose:

Prevention

Official Title:

Cardiopulmonary Rehabilitation in Long COVID-19 Patients With Persistent Breathlessness and Fatigue

Actual Study Start Date :

Aug 15, 2021

Anticipated Primary Completion Date :

Aug 15, 2022

Anticipated Study Completion Date :

Aug 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiopulmonary exercise training group Cardiopulmonary exercise intervention will include aerobic exercise, resistance and respiratory exercises, three sessions per week for 2 months	Other: Cardiopulmonary exercise training 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.
No Intervention: control group Control group with no intervention.

Arm

Intervention/Treatment

Experimental: Cardiopulmonary exercise training group

Cardiopulmonary exercise intervention will include aerobic exercise, resistance and respiratory exercises, three sessions per week for 2 months

Other: Cardiopulmonary exercise training

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.

No Intervention: control group

Control group with no intervention.

Outcome Measures

Primary Outcome Measures

Change in cardiorespiratory fitness [Baseline and post-intervention at 2 months]
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)

Secondary Outcome Measures

Change in 6-min walking test performance [Baseline and post-intervention at 2 months]
maximum distance performed in 6 minutes (distance, m)
Change in Functional mobility [Baseline and post-intervention at 2 months]
Timed up and Go test (s).
Change in Lower limb muscles strength [Baseline and post-intervention at 2 months]
Timed Sit-to-Stand test (s).
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 Anxiety [Baseline and post-intervention at 2 months]
State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).
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 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 executive functions [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 inflammatory profile [Baseline and post-intervention at 2 months]
C-reactive protein (mg/L/L)
Change in oxidative stress [Baseline and post-intervention at 2 months]
serum levels of uric acid (mg/dL), albumin (g/L)
Change in markers of coagulation [Baseline and post-intervention at 2 months]
fibrinogen (g/L)
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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 50 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.

Exclusion Criteria:

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)