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

November 1, 2024 updated by: Louis Bherer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T1N6
        • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiorespiratory fitness
Time Frame: Baseline and post-intervention at 2 months
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)
Baseline and post-intervention at 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-min walking test performance
Time Frame: Baseline and post-intervention at 2 months
maximum distance performed in 6 minutes (distance, m)
Baseline and post-intervention at 2 months
Change in Functional mobility
Time Frame: Baseline and post-intervention at 2 months
Timed up and Go test (s).
Baseline and post-intervention at 2 months
Change in Lower limb muscles strength
Time Frame: Baseline and post-intervention at 2 months
Timed Sit-to-Stand test (s).
Baseline and post-intervention at 2 months
Change in Quality-of-life
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).
Baseline and post-intervention at 2 months
Change in Anxiety
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).
Baseline and post-intervention at 2 months
Change in 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).
Baseline and post-intervention at 2 months
Change in Sleep quality
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).
Baseline and post-intervention at 2 months
Change in functional respiratory capacity
Time Frame: Baseline and post-intervention at 2 months
forced expiratory volume in 1 second (L.)
Baseline and post-intervention at 2 months
Change in general cognitive functioning
Time Frame: Baseline and post-intervention at 2 months
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Baseline and post-intervention at 2 months
Change in processing speed
Time Frame: Baseline and post-intervention at 2 months
Validated remote version of neuropsychological tests (Z-score)
Baseline and post-intervention at 2 months
Change in executive functions
Time Frame: Baseline and post-intervention at 2 months
Validated remote version of neuropsychological tests (Z-score)
Baseline and post-intervention at 2 months
Change in episodic memory
Time Frame: Baseline and post-intervention at 2 months
Validated remote version of neuropsychological tests (Z-score)
Baseline and post-intervention at 2 months
Change in inflammatory profile
Time Frame: Baseline and post-intervention at 2 months
C-reactive protein (mg/L/L)
Baseline and post-intervention at 2 months
Change in oxidative stress
Time Frame: Baseline and post-intervention at 2 months
serum levels of uric acid (mg/dL), albumin (g/L)
Baseline and post-intervention at 2 months
Change in markers of coagulation
Time Frame: Baseline and post-intervention at 2 months
fibrinogen (g/L)
Baseline and post-intervention at 2 months
Change in neurovascular coupling
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.
Baseline and post-intervention at 2 months
Change in cerebral pulsatility - cortical frontal region
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.
Baseline and post-intervention at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Bherer

Investigators

  • Principal Investigator: Jacques Malo, MD, Montreal Heart Institute
  • Principal Investigator: Louis Bherer, PhD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2956

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Respiratory Infection

Clinical Trials on Cardiopulmonary exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe