COVID-19NCT05532995

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

An observational study of COVID-19, run by Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie at 29 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
How many people: 1,200 participants
Where: 29 sitesin 4 countries
Study dates: 15 Jul 2022to 31 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

29 sites in 4 countries.

Country

City, postcode or hospital

29 sites in 4 countries

France26 sites

University Hosp. Amiens-Picardie
Amiens
Angers University Hosp.
Angers
AP-HP University Hosp. Avicenne
Bobigny
Brest University Hosp. Cavale Blanche
Brest
Hosp. Louis Pradel
Bron
SSR Marguerite Boucicaut French Red Cross
Chalon-sur-Saône
University Hosp. Gabriel-Montpied
Clermont-Ferrand
Corbie General Hosp. (Réadaptation)
Corbie
Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé
Dieulefit
Centre Médical Bayère
Gleizé
Grenoble Alpes University Hosp. Michallon Nord
Grenoble
Grenoble Alpes University Hosp. Michallon Sud
Grenoble
Hosp. St Philibert GH Catholique Institute Lille
Lille
Limoges General Hosp.
Limoges
Medical Center Parot
Lyon
Médipôle Lyon-Villeurbanne
Lyon
Nice University Hosp. Pasteur
Nice
Clinique Les Rieux
Nyons
AP-HP Hôpital Bichat Claude-Bernard
Paris
AP-HP University Hosp. Cochin
Paris
AP-HP University Hosp. Pitié Salpêtrière
Paris
Polyclinique Les Bleuets
Reims
University Hosp. of Pontchaillou
Rennes
Rouen University Hosp. Charles-Nicolle
Rouen
Toulouse University Hosp.
Toulouse
Tours University Hosp. Bretonneau
Tours

Other trials in France

Canada1 site

Hosp. Maisonneuve-Rosemont
Montreal

Other trials in Canada

Martinique1 site

Clinique Saint Paul
Fort-de-France

Other trials in Martinique

Switzerland1 site

Geneva University Hosp.
Geneva

Other trials in Switzerland

About this study

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

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
Medical subject headings: COVID-19, Post-Acute COVID-19 Syndrome, Respiratory Aspiration, Dyspnea

What is being measured

The primary outcome is the main question the study is designed to answer.

An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202231 Dec 2023

First posted8 Sep 2022
Study start15 Jul 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 1,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05532995
Sponsor's protocol ID: ACCPP-PROT2022-01
Status last verified: May 2024
First submitted: 31 Aug 2022
Last updated: 21 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33361097
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.
PubMed 33647535
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.
PubMed 33020140
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.
PubMed 33623700
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.
PubMed 33630906
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.
PubMed 33536937
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.
PubMed 33735374
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.
PubMed 33809260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05532995
Acronym / sponsor ID: ACCPP-PROT2022-01
Conditions: COVID-19
Keywords: Long COVID, Exercise test, Post-acute COVID syndrome, Sars-Cov-2, Multi-centric study, Respiration, Dyspnoea, Exercise intolerance
Study type: Observational
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: Association pour la Complementarite des Connaissances et des Pratiques de la PneumologieUniversity, hospital or other
Collaborators: Menarini Group, Hylab, Grenoble, AstraZeneca
Study start: 15 Jul 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 8 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder
Time frame: 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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Background: PubMed 33361097Gao 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.
Background: PubMed 33647535Cortes-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.
Background: PubMed 33020140Gervasi 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.
Background: PubMed 33623700Mohr 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.
Background: PubMed 33630906Townsend 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.
Background: PubMed 33536937Motiejunaite 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.
Background: PubMed 33735374Debeaumont 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.
Background: PubMed 33809260Dorelli 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.
Individual participant dataSharing planned: Undecided

Related trials for COVID-19

RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard Aguilaniu, M.D. PhD study director

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

PierAntonio Laveneziana, M.D. PhD principal investigator

University Hospital La Pitié-Salpêtrière

Frédéric Costes, M.D. PhD principal investigator

University Hospital, Clermont-Ferrand

29 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie at 29 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France, Canada, Martinique, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

An abnormal CPET due to either decreased respiratory capacity, excessive dyspneoa, deconditioning or breathing disorder (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05532995, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.