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

NCT05532995 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-05-21

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Menarini Group

    collaborator INDUSTRY
  • Hylab, Grenoble

    collaborator OTHER
  • AstraZeneca

    collaborator INDUSTRY
  • Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

    lead OTHER

Principal Investigators

  • Bernard Aguilaniu, M.D. PhD · Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

  • PierAntonio Laveneziana, M.D. PhD · University Hospital La Pitié-Salpêtrière

  • Frédéric Costes, M.D. PhD · University Hospital, Clermont-Ferrand

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada
  • France
  • Martinique
  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532995 on ClinicalTrials.gov