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

NCT05532995 | Completed

• 1 other identifier: ACCPP-PROT2022-01
• Study Type: observational
• Target: 1,200
• Locations: 4 countries
• Sites: 29

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.

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

Outcome Measures

Primary Outcomes (1)

• An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder

  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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie: lead
• Menarini Group: collaborator
• Hylab, Grenoble: collaborator
• AstraZeneca: collaborator

Study Sites (29)

Hosp. Maisonneuve-Rosemont

Montreal, Canada

Location

University Hosp. Amiens-Picardie

Amiens, France

Location

Angers University Hosp.

Angers, France

Location

AP-HP University Hosp. Avicenne

Bobigny, France

Location

Brest University Hosp. Cavale Blanche

Brest, France

Location

Hosp. Louis Pradel

Bron, France

Location

SSR Marguerite Boucicaut French Red Cross

Chalon-sur-Saône, France

Location

University Hosp. Gabriel-Montpied

Clermont-Ferrand, France

Location

Corbie General Hosp. (Réadaptation)

Corbie, France

Location

Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé

Dieulefit, France

Location

Centre Médical Bayère

Gleizé, France

Location

Grenoble Alpes University Hosp. Michallon Nord

Grenoble, France

Location

Grenoble Alpes University Hosp. Michallon Sud

Grenoble, France

Location

Hosp. St Philibert GH Catholique Institute Lille

Lille, France

Location

Limoges General Hosp.

Limoges, France

Location

Medical Center Parot

Lyon, France

Location

Médipôle Lyon-Villeurbanne

Lyon, France

Location

Nice University Hosp. Pasteur

Nice, France

Location

Clinique Les Rieux

Nyons, France

Location

AP-HP Hôpital Bichat Claude-Bernard

Paris, France

Location

AP-HP University Hosp. Cochin

Paris, France

Location

AP-HP University Hosp. Pitié Salpêtrière

Paris, France

Location

Polyclinique Les Bleuets

Reims, France

Location

University Hosp. of Pontchaillou

Rennes, France

Location

Rouen University Hosp. Charles-Nicolle

Rouen, France

Location

Toulouse University Hosp.

Toulouse, France

Location

Tours University Hosp. Bretonneau

Tours, France

Location

Clinique Saint Paul

Fort-de-France, Martinique

Location

Geneva University Hosp.

Geneva, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 33361097 BACKGROUND

• 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.

  PMID: 33647535 BACKGROUND

• 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.

  PMID: 33020140 BACKGROUND

• 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.

  PMID: 33623700 BACKGROUND

• 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.

  PMID: 33630906 BACKGROUND

• 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.

  PMID: 33536937 BACKGROUND

• 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.

  PMID: 33735374 BACKGROUND

• 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.

  PMID: 33809260 BACKGROUND

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Respiratory Aspiration; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Bernard Aguilaniu, M.D. PhD

  Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

  STUDY DIRECTOR

• PierAntonio Laveneziana, M.D. PhD

  University Hospital La Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

• Frédéric Costes, M.D. PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 8, 2022
• Study Start: July 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CH (1); FR (26); CA (1); MA (1)