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
- Diseases
- Long COVID and ME/CFS
- 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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hosp. Maisonneuve-Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Geneva University Hosp. Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| University Hosp. Amiens-Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Angers University Hosp. Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| AP-HP University Hosp. Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| Brest University Hosp. Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Hosp. Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| SSR Marguerite Boucicaut French Red Cross Coordinator of this site? Confirm its status | Chalon-sur-Saône | France | Unknown status |
| University Hosp. Gabriel-Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Corbie General Hosp. (Réadaptation) Coordinator of this site? Confirm its status | Corbie | France | Unknown status |
| Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé Coordinator of this site? Confirm its status | Dieulefit | France | Unknown status |
| Centre Médical Bayère Coordinator of this site? Confirm its status | Gleizé | France | Unknown status |
| Grenoble Alpes University Hosp. Michallon Nord Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Grenoble Alpes University Hosp. Michallon Sud Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hosp. St Philibert GH Catholique Institute Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Limoges General Hosp. Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Medical Center Parot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Médipôle Lyon-Villeurbanne Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Nice University Hosp. Pasteur Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Clinique Les Rieux Coordinator of this site? Confirm its status | Nyons | France | Unknown status |
| AP-HP Hôpital Bichat Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| AP-HP University Hosp. Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| AP-HP University Hosp. Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Polyclinique Les Bleuets Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| University Hosp. of Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Rouen University Hosp. Charles-Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Toulouse University Hosp. Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Tours University Hosp. Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Clinique Saint Paul Coordinator of this site? Confirm its status | Fort-de-France | Martinique | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.