- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548505
Recovery of Exertion Ability Following COVID-19 Infection in Military Staff (CovEx)
The Paris Fire Brigade staff have been particularly exposed to COVID-19 due to rescue and care activities for victims at risk in Paris area (where the virus was actively circulating). In addition, when the pandemic began in France, they had to take care of patients before procedures to protect caregivers were implemented.
The contamination of young military personnel, whose physical capacity was put into strain at work, raises the question of the consequences of COVID-19 on their physical fitness. At the time, the medium- and long-term evolution of this disease and its possible repercussions on physical fitness are unknown. Moreover, like any soldiers who have been confined, they may present at least a cardio-respiratory deconditioning (sometimes independent of the disease making it difficult to distinguish between a sequelae of the infection or rehabilitation).
Based on previous coronavirus epidemics (Sars-Cov 1 and Mers-Cov), it appears that long-term sequelae are possible even in mild forms and can result in an alteration of exertion ability.
In the current context and in the absence of national or international recommendations on the return to physical activity, the French Armed Forces Health Service has proposed a simple management plan aiming at: i) allowing mass screening for possible exercise intolerance and targeting at-risk personnel, ii) allowing individualized re-training and iii) guaranteeing that military personnel can carry out their mission without jeopardizing their health.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alexandra MALGOYRE, MD, PhD
- Phone Number: +33 169631317
- Email: alexandra.malgoyre@intradef.gouv.fr
Study Locations
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Brétigny-sur-Orge, France, 91223
- Recruiting
- Institut de Recherche Biomédicale des Armées
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Contact:
- Alexandra MALGOYRE, MD, PhD
- Phone Number: +33 169631317
- Email: alexandra.malgoyre@intradef.gouv.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be an active military personnel of the Paris Fire Brigade
- Be at least 18 years of age
- Benefiting or having benefited from the post-COVID medical care provided by the French Armed Forces Health Service
Exclusion Criteria:
- Be under 18 years of age
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnitude of the decrease in aerobic performance on return to work
Time Frame: Up to 18 months
|
Aerobic performance will be assessed through a test called VAMEVAL.
VAMEVAL consists of running around a track marked out every 50 meters to the rhythm of a soundtrack that accelerates at a rate of 0.5 km/h in 2-minute increments until exhaustion or inability to maintain the pace of the race.
The result of the test made on return to work will be compared to the last result on the same test performed before COVID-19 infection.
|
Up to 18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-COVID19-30
- 2020-A02140-39 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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