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

NCT05035628 | Completed DMC

• 1 other identifier: 2021-2956
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection

Keywords

COVID-19; cardiorespiratory; fitness; cognition; neurovascular coupling; brain functions; physical exercise; rehabilitation; inflammatory markers; long COVID-19; cortical pulsatility

Outcome Measures

Primary Outcomes (1)

• Change in cardiorespiratory fitness

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

  Baseline and post-intervention at 2 months

Secondary Outcomes (17)

• Change in 6-min walking test performance

  Baseline and post-intervention at 2 months

• Change in Functional mobility

  Baseline and post-intervention at 2 months

• Change in Lower limb muscles strength

  Baseline and post-intervention at 2 months

• Change in Quality-of-life

  Baseline and post-intervention at 2 months

• Change in Anxiety

  Baseline and post-intervention at 2 months

Study Arms (2)

Cardiopulmonary exercise training group

EXPERIMENTAL

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

Other: Cardiopulmonary exercise training

control group

NO INTERVENTION

Control group with no intervention.

Interventions

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.

Cardiopulmonary exercise training group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Louis Bherer: lead

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

Related Publications (3)

• Gaudreau-Majeau F, Gagnon C, Djedaa SC, Berube B, Malo J, Iglesies-Grau J, Gayda M, Bherer L, Besnier F. Cardiopulmonary rehabilitation's influence on cognitive functions, psychological state, and sleep quality in long COVID-19 patients: A randomized controlled trial. Neuropsychol Rehabil. 2025 Mar;35(2):345-361. doi: 10.1080/09602011.2024.2338613. Epub 2024 Apr 12.

  PMID: 38607276 RESULT

• Besnier F, Malo J, Mohammadi H, Clavet S, Klai C, Martin N, Berube B, Lecchino C, Iglesies-Grau J, Vincent T, Gagnon C, Gaudreau-Majeau F, Juneau M, Simard F, L'Allier P, Nigam A, Gayda M, Bherer L. Effects of Cardiopulmonary Rehabilitation on Cardiorespiratory Fitness and Clinical Symptom Burden in Long COVID: Results From the COVID-Rehab Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Feb 1;104(2):163-171. doi: 10.1097/PHM.0000000000002559. Epub 2024 Jun 24.

  PMID: 38917451 RESULT

• Besnier F, Berube B, Malo J, Gagnon C, Gregoire CA, Juneau M, Simard F, L'Allier P, Nigam A, Iglesies-Grau J, Vincent T, Talamonti D, Dupuy EG, Mohammadi H, Gayda M, Bherer L. Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. Int J Environ Res Public Health. 2022 Mar 31;19(7):4133. doi: 10.3390/ijerph19074133.

  PMID: 35409815 DERIVED

MeSH Terms

Conditions

COVID-19; Motor Activity; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Louis Bherer, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Jacques Malo, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This clinical trial is a single-blinded study. Research personnel performing the outcome assessments and investigators will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate scientific director, Direction of prevention, Montreal Heart Institute

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

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: September 15, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)