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Completed

NCT Number: NCT05035628

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiopulmonary exercise training

Other

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.

Primary outcomes

  1. Change in cardiorespiratory fitness

    Time frame: Baseline and post-intervention at 2 months

    Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)

Secondary outcomes

  1. Change in 6-min walking test performance

    Time frame: Baseline and post-intervention at 2 months

    maximum distance performed in 6 minutes (distance, m)

  2. Change in Functional mobility

    Time frame: Baseline and post-intervention at 2 months

    Timed up and Go test (s).

  3. Change in Lower limb muscles strength

    Time frame: Baseline and post-intervention at 2 months

    Timed Sit-to-Stand test (s).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. Change in functional respiratory capacity

    Time frame: Baseline and post-intervention at 2 months

    forced expiratory volume in 1 second (L.)

  9. 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).

  10. Change in processing speed

    Time frame: Baseline and post-intervention at 2 months

    Validated remote version of neuropsychological tests (Z-score)

  11. Change in executive functions

    Time frame: Baseline and post-intervention at 2 months

    Validated remote version of neuropsychological tests (Z-score)

  12. Change in episodic memory

    Time frame: Baseline and post-intervention at 2 months

    Validated remote version of neuropsychological tests (Z-score)

  13. Change in inflammatory profile

    Time frame: Baseline and post-intervention at 2 months

    C-reactive protein (mg/L/L)

  14. Change in oxidative stress

    Time frame: Baseline and post-intervention at 2 months

    serum levels of uric acid (mg/dL), albumin (g/L)

  15. Change in markers of coagulation

    Time frame: Baseline and post-intervention at 2 months

    fibrinogen (g/L)

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

Louis Bherer

Other

Registry information

Acronym: COVID-Rehab

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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