Responses to CPET in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network
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| ClinicalTrials.gov Identifier: NCT05532995 |
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Recruitment Status :
Recruiting
First Posted : September 8, 2022
Last Update Posted : September 8, 2022
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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 May 31, 2022 (i.e. 29 months), The retrospective data collection will be carried out from September 19, 2022 to June 1, 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 600 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.
| Condition or disease |
|---|
| COVID-19 |
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| 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 |
| Actual Study Start Date : | June 1, 2022 |
| Estimated Primary Completion Date : | May 31, 2023 |
| Estimated Study Completion Date : | May 31, 2023 |
- 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 (March 2023). ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 June 1, 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05532995
| Contact: Lara Andres-Rieth, Master | +33 760 075 209 | LA_EFX-PostCOVID@protonmail.com | |
| Contact: Anne Rigal, Pharm. PhD | recherche@accpp.fr |
Show 21 study locations
| Study Director: | Bernard Aguilaniu, M.D. PhD | Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie | |
| Principal Investigator: | PierAntonio Laveneziana, M.D. PhD | University Hospital La Pitié-Salpêtrière | |
| Principal Investigator: | Frédéric Costes, M.D. PhD | University Hospital, Clermont-Ferrand |
Documents provided by Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie:
Publications:
| Responsible Party: | Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie |
| ClinicalTrials.gov Identifier: | NCT05532995 |
| Other Study ID Numbers: |
ACCPP-PROT2022-01 |
| First Posted: | September 8, 2022 Key Record Dates |
| Last Update Posted: | September 8, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |