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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532995
• Other study ID #: ACCPP-PROT2022-01
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie
• Contact: Lara Andres-Rieth, Master
• Phone: +33 760 075 209
• Email: recherche[@]accpp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, 2022
• 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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Canada	Hosp. Maisonneuve-Rosemont	Montréal
France	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	General Hosp. Métropole Savoie	Chambéry
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	Hosp. Nord-Ouest Villefranche-sur-Saône	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	Strasbourg University Hosp.	Strasbourg
France	Toulouse University Hosp.	Toulouse
France	Tours University Hosp. Bretonneau	Tours
Martinique	Clinique Saint Paul	Fort-de-France
Martinique	Martinique General Hosp.	Fort-de-France
Switzerland	Geneva University Hosp.	Geneva

Sponsors (4)

Lead Sponsor	Collaborator
Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie	AstraZeneca, Hylab, Grenoble, Menarini Group

Countries where clinical trial is conducted

Canada,  France,  Martinique,  Switzerland, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (March 2023).