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NCT05532995Completed

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

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

Source: ClinicalTrials.gov · Last updated 21 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1200 (actual)
First submitted
31 Aug 2022
Start date
15 Jul 2022
Primary completion date
31 Dec 2023
Lead sponsor
Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
NCT number
NCT05532995

What you commit to

  • Study type: Observational
  • Participants enrolled: 1200
  • From 15 Jul 2022 to the primary completion date, 31 Dec 2023
  • 29 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age \< 18 years

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hosp. Maisonneuve-Rosemont
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MontrealCanadaUnknown status
Geneva University Hosp.
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GenevaSwitzerlandUnknown status
University Hosp. Amiens-Picardie
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AmiensFranceUnknown status
Angers University Hosp.
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AngersFranceUnknown status
AP-HP University Hosp. Avicenne
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BobignyFranceUnknown status
Brest University Hosp. Cavale Blanche
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BrestFranceUnknown status
Hosp. Louis Pradel
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BronFranceUnknown status
SSR Marguerite Boucicaut French Red Cross
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Chalon-sur-SaôneFranceUnknown status
University Hosp. Gabriel-Montpied
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Clermont-FerrandFranceUnknown status
Corbie General Hosp. (Réadaptation)
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CorbieFranceUnknown status
Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé
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DieulefitFranceUnknown status
Centre Médical Bayère
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GleizéFranceUnknown status
Grenoble Alpes University Hosp. Michallon Nord
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GrenobleFranceUnknown status
Grenoble Alpes University Hosp. Michallon Sud
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GrenobleFranceUnknown status
Hosp. St Philibert GH Catholique Institute Lille
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LilleFranceUnknown status
Limoges General Hosp.
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LimogesFranceUnknown status
Medical Center Parot
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LyonFranceUnknown status
Médipôle Lyon-Villeurbanne
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LyonFranceUnknown status
Nice University Hosp. Pasteur
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NiceFranceUnknown status
Clinique Les Rieux
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NyonsFranceUnknown status
AP-HP Hôpital Bichat Claude-Bernard
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ParisFranceUnknown status
AP-HP University Hosp. Pitié Salpêtrière
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ParisFranceUnknown status
AP-HP University Hosp. Cochin
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ParisFranceUnknown status
Polyclinique Les Bleuets
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ReimsFranceUnknown status
University Hosp. of Pontchaillou
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RennesFranceUnknown status
Rouen University Hosp. Charles-Nicolle
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RouenFranceUnknown status
Toulouse University Hosp.
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ToulouseFranceUnknown status
Tours University Hosp. Bretonneau
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ToursFranceUnknown status
Clinique Saint Paul
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Fort-de-FranceMartiniqueUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.