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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04548505
Other study ID # 2020-COVID19-30
Secondary ID 2020-A02140-39
Status Recruiting
Phase
First received
Last updated
Start date October 5, 2020
Est. completion date April 5, 2023

Study information

Verified date March 2021
Source Direction Centrale du Service de Santé des Armées
Contact Alexandra MALGOYRE, MD, PhD
Phone 169631317
Email alexandra.malgoyre@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 5, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Magnitude of the decrease in aerobic performance on return to work 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
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