Responses to CPET in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network

May 20, 2024 updated by: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

Kinetics of Physiological and Symptomatic Responses to CardioPulmonary Exercise Testing (CPET) in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network

This retrospective collaborative study on persistent exercise intolerance after COVID-19 offers to perform a large descriptive analysis of CPET performed in real-life by pulmonologists, cardiologists and physiologists. Indeed, these practicians are regularly consulted for a persistent intolerance to exercise expressed by dyspnea and/or frank fatigability sometimes associated with muscular or thoracic pain. When these complaints persist beyond 3 months after the first symptoms, it is legitimate to perform a CPET:

  • Either to evaluate the functional impact of an identified organ deficiency (e.g. myocarditis, pulmonary fibrosis, etc.),
  • Or, in the absence of formal arguments for an identified organ deficiency, to observe possible abnormalities in physiological responses during an incremental exercise test, likely to explain the persistence of symptoms and intolerance to exercise. Indeed, the recent literature highlights the presence of non-specific ventilatory and cardio-circulatory abnormalities leading to various physio-pathological observations. Unfortunately, these reports now concern relatively small numbers of patients with very diverse clinical forms of Covid, comorbidities and habitus.

In order to improve the understanding of persistent symptoms and in particular the diversity of physiological response presentations, the investigators propose to collect a very large amount of data through a web-based platform designed to collect the measurements made throughout the exercise test directly from the ergospirometer.

The relevant data covers the period from January 2, 2020 to December 31, 2022 (i.e. 35 months), The retrospective data collection will be carried out from February 1, 2023 to December 31, 2023.

The descriptive analysis will focus on the kinetics of all the variables measured and calculated on subgroups defined a priori on age, sex, comorbidities, acute covid severity, persistent symptoms post covid, regular habitual physical activity level, etc. according to the sample.

The study is expected to collect data from around 1000 patients and to involve around 40 French-speaking investigators. However, this collaborative study is open on request to all centers wishing to participate, as the web platform has been developed for data collection in English.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1200

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
      • Montréal, Canada
        • Hosp. Maisonneuve-Rosemont
  • France
      • Amiens, France
        • University Hosp. Amiens-Picardie
      • Angers, France
        • Angers University Hosp.
      • Bobigny, France
        • AP-HP University Hosp. Avicenne
      • Brest, France
        • Brest University Hosp. Cavale Blanche
      • Bron, France
        • Hosp. Louis Pradel
      • Chalon-sur-Saône, France
        • SSR Marguerite Boucicaut French Red Cross
      • Clermont-Ferrand, France
        • University Hosp. Gabriel-Montpied
      • Corbie, France
        • Corbie General Hosp. (Réadaptation)
      • Dieulefit, France
        • Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé
      • Gleizé, France
        • Centre Médical Bayère
      • Grenoble, France
        • Grenoble Alpes University Hosp. Michallon Nord
      • Grenoble, France
        • Grenoble Alpes University Hosp. Michallon Sud
      • Lille, France
        • Hosp. St Philibert GH Catholique Institute Lille
      • Limoges, France
        • Limoges General Hosp.
      • Lyon, France
        • Medical Center Parot
      • Lyon, France
        • Medipole Lyon-Villeurbanne
      • Nice, France
        • Nice University Hosp. Pasteur
      • Nyons, France
        • Clinique Les Rieux
      • Paris, France
        • AP-HP Hôpital Bichat Claude-Bernard
      • Paris, France
        • AP-HP University Hosp. Cochin
      • Paris, France
        • AP-HP University Hosp. Pitié Salpêtrière
      • Reims, France
        • Polyclinique Les Bleuets
      • Rennes, France
        • University Hosp. of Pontchaillou
      • Rouen, France
        • Rouen University Hosp. Charles-Nicolle
      • Toulouse, France
        • Toulouse University Hosp.
      • Tours, France
        • Tours University Hosp. Bretonneau
  • Martinique
      • Fort-de-France, Martinique
        • Clinique Saint Paul
  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hosp.

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with exercise intolerance after COVID-19, diagnosed between January 2, 2020 and December 31, 2023, who have been informed that the physiological data collected during the CPET and the clinical data necessary for its interpretation may be used for clinical research.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with persistent symptoms 3 months after the onset of Covid-19 infection, regardless the severity of the initial illness
  • Patients with an ICU stay, primarily following rehabilitation management; that is, in practice, at least 6 months after COVID
  • Patients followed by a pulmonologist, cardiologist or physiologist in a public or private facility or in private practice, allowing for CPET
  • Patients who have performed a CPET before December 31, 2023
  • Patients informed of the possible anonymized processing of the data collected during CPET for research purposes; and who gave informed consent

Exclusion Criteria:

  • Age < 18 years
  • Patients unable to perform CPET for locomotor reasons
  • Patients with severely reduced functional work capacity
  • Patient deprived of liberty by judicial or administrative decision
  • Patients unable to give informed consent

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder
Time Frame: A descriptive analysis of all evaluation criteria will be performed on the total population and on subgroups to be defined a posteriori according to the sample (December 2023).
A descriptive analysis of all evaluation criteria will be performed on the total population and on subgroups to be defined a posteriori according to the sample (December 2023).

Collaborators and Investigators

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

Sponsor

Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

Collaborators

AstraZeneca
Menarini Group
Hylab, Grenoble

Investigators

  • Study Director: Bernard Aguilaniu, M.D. PhD, Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
  • Principal Investigator: PierAntonio Laveneziana, M.D. PhD, University Hospital La Pitié-Salpêtrière
  • Principal Investigator: Frédéric Costes, M.D. PhD, University Hospital, Clermont-Ferrand

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)

July 15, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCPP-PROT2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Informational website about all the research projects sponsored by the aCCPP
  2. Informed Consent Form

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.

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