Clinical trial NCT05532995: Responses to CPET in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Long COVID
Exercise test
Post-acute COVID syndrome
Sars-Cov-2
Multi-centric study
Respiration
Dyspnoea
Exercise intolerance
Fatiguability
Open-Source Network
Lead sponsor: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
Sponsor class: OTHER
Collaborators: name: Menarini Group
name: Hylab, Grenoble
name: AstraZeneca
First posted: 2022-09-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hosp. Maisonneuve-Rosemont
city: Amiens
country: France
facility: University Hosp. Amiens-Picardie
city: Angers
country: France
facility: Angers University Hosp.
city: Bobigny
country: France
facility: AP-HP University Hosp. Avicenne
city: Brest
country: France
facility: Brest University Hosp. Cavale Blanche
city: Bron
country: France
facility: Hosp. Louis Pradel
city: Chalon-sur-Saône
country: France
facility: SSR Marguerite Boucicaut French Red Cross
city: Clermont-Ferrand
country: France
facility: University Hosp. Gabriel-Montpied
city: Corbie
country: France
facility: Corbie General Hosp. (Réadaptation)
city: Dieulefit
country: France
facility: Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé
city: Gleizé
country: France
facility: Centre Médical Bayère
city: Grenoble
country: France
facility: Grenoble Alpes University Hosp. Michallon Nord
city: Grenoble
country: France
facility: Grenoble Alpes University Hosp. Michallon Sud
city: Lille
country: France
facility: Hosp. St Philibert GH Catholique Institute Lille
city: Limoges
country: France
facility: Limoges General Hosp.
city: Lyon
country: France
facility: Medical Center Parot
city: Lyon
country: France
facility: Médipôle Lyon-Villeurbanne
city: Nice
country: France
facility: Nice University Hosp. Pasteur
city: Nyons
country: France
facility: Clinique Les Rieux
city: Paris
country: France
facility: AP-HP Hôpital Bichat Claude-Bernard
city: Paris
country: France
facility: AP-HP University Hosp. Cochin
city: Paris
country: France
facility: AP-HP University Hosp. Pitié Salpêtrière
city: Reims
country: France
facility: Polyclinique Les Bleuets
city: Rennes
country: France
facility: University Hosp. of Pontchaillou
city: Rouen
country: France
facility: Rouen University Hosp. Charles-Nicolle
city: Toulouse
country: France
facility: Toulouse University Hosp.
city: Tours
country: France
facility: Tours University Hosp. Bretonneau
city: Fort-de-France
country: Martinique
facility: Clinique Saint Paul
city: Geneva
country: Switzerland
facility: Geneva University Hosp.
Study officials:
affiliation: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
name: Bernard Aguilaniu, M.D. PhD
role: STUDY_DIRECTOR
affiliation: University Hospital La Pitié-Salpêtrière
name: PierAntonio Laveneziana, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Costes, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.