Responses to CPET in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network
NCT ID: NCT05532995
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1200 participants
OBSERVATIONAL
2022-07-15
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Persistent Dyspnea in Post COVID_19 and Pulmonary Function
NCT05228678
Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
NCT01214551
Predictive Properties of the 6-Minute Stepper Test for Mortality in COPD
NCT06703359
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease
NCT03014609
Long COVID and Post-exertional Pulmonary Diffusion
NCT05430503
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Menarini Group
INDUSTRY
Hylab, Grenoble
OTHER
AstraZeneca
INDUSTRY
Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bernard Aguilaniu, M.D. PhD
Role: STUDY_DIRECTOR
Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
PierAntonio Laveneziana, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital La Pitié-Salpêtrière
Frédéric Costes, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hosp. Maisonneuve-Rosemont
Montreal, , Canada
University Hosp. Amiens-Picardie
Amiens, , France
Angers University Hosp.
Angers, , France
AP-HP University Hosp. Avicenne
Bobigny, , France
Brest University Hosp. Cavale Blanche
Brest, , France
Hosp. Louis Pradel
Bron, , France
SSR Marguerite Boucicaut French Red Cross
Chalon-sur-Saône, , France
University Hosp. Gabriel-Montpied
Clermont-Ferrand, , France
Corbie General Hosp. (Réadaptation)
Corbie, , France
Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé
Dieulefit, , France
Centre Médical Bayère
Gleizé, , France
Grenoble Alpes University Hosp. Michallon Nord
Grenoble, , France
Grenoble Alpes University Hosp. Michallon Sud
Grenoble, , France
Hosp. St Philibert GH Catholique Institute Lille
Lille, , France
Limoges General Hosp.
Limoges, , France
Medical Center Parot
Lyon, , France
Médipôle Lyon-Villeurbanne
Lyon, , France
Nice University Hosp. Pasteur
Nice, , France
Clinique Les Rieux
Nyons, , France
AP-HP Hôpital Bichat Claude-Bernard
Paris, , France
AP-HP University Hosp. Cochin
Paris, , France
AP-HP University Hosp. Pitié Salpêtrière
Paris, , France
Polyclinique Les Bleuets
Reims, , France
University Hosp. of Pontchaillou
Rennes, , France
Rouen University Hosp. Charles-Nicolle
Rouen, , France
Toulouse University Hosp.
Toulouse, , France
Tours University Hosp. Bretonneau
Tours, , France
Clinique Saint Paul
Fort-de-France, , Martinique
Geneva University Hosp.
Geneva, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gao Y, Chen R, Geng Q, Mo X, Zhan C, Jian W, Li S, Zheng J. Cardiopulmonary exercise testing might be helpful for interpretation of impaired pulmonary function in recovered COVID-19 patients. Eur Respir J. 2021 Jan 28;57(1):2004265. doi: 10.1183/13993003.04265-2020. Print 2021 Jan.
Cortes-Telles A, Lopez-Romero S, Figueroa-Hurtado E, Pou-Aguilar YN, Wong AW, Milne KM, Ryerson CJ, Guenette JA. Pulmonary function and functional capacity in COVID-19 survivors with persistent dyspnoea. Respir Physiol Neurobiol. 2021 Jun;288:103644. doi: 10.1016/j.resp.2021.103644. Epub 2021 Feb 27.
Gervasi SF, Pengue L, Damato L, Monti R, Pradella S, Pirronti T, Bartoloni A, Epifani F, Saggese A, Cuccaro F, Bianco M, Zeppilli P, Palmieri V. Is extensive cardiopulmonary screening useful in athletes with previous asymptomatic or mild SARS-CoV-2 infection? Br J Sports Med. 2021 Jan;55(1):54-61. doi: 10.1136/bjsports-2020-102789. Epub 2020 Oct 5.
Mohr A, Dannerbeck L, Lange TJ, Pfeifer M, Blaas S, Salzberger B, Hitzenbichler F, Koch M. Cardiopulmonary exercise pattern in patients with persistent dyspnoea after recovery from COVID-19. Multidiscip Respir Med. 2021 Jan 25;16(1):732. doi: 10.4081/mrm.2021.732. eCollection 2021 Jan 15.
Townsend L, Moloney D, Finucane C, McCarthy K, Bergin C, Bannan C, Kenny RA. Fatigue following COVID-19 infection is not associated with autonomic dysfunction. PLoS One. 2021 Feb 25;16(2):e0247280. doi: 10.1371/journal.pone.0247280. eCollection 2021.
Motiejunaite J, Balagny P, Arnoult F, Mangin L, Bancal C, d'Ortho MP, Frija-Masson J. Hyperventilation: A Possible Explanation for Long-Lasting Exercise Intolerance in Mild COVID-19 Survivors? Front Physiol. 2021 Jan 18;11:614590. doi: 10.3389/fphys.2020.614590. eCollection 2020.
Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.
Dorelli G, Braggio M, Gabbiani D, Busti F, Caminati M, Senna G, Girelli D, Laveneziana P, Ferrari M, Sartori G, Dalle Carbonare L, Crisafulli E, On Behalf Of The Respicovid Study Investigators. Importance of Cardiopulmonary Exercise Testing amongst Subjects Recovering from COVID-19. Diagnostics (Basel). 2021 Mar 12;11(3):507. doi: 10.3390/diagnostics11030507.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Informed Consent Form
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Informed Consent Form
View DocumentOther Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACCPP-PROT2022-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.