NCT04548505

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

September 11, 2020

Last Update Submit

March 8, 2021

Conditions

Keywords

physical activity

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population is composed of active military personnel of the Paris Fire Brigade who have been infected with COVID-19 and thus are benefiting or have benefited from the post-COVID medical car provided bay the French Armed Forces Health Service.

You may qualify if:

  • 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

You may not qualify if:

  • Be under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

RECRUITING

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBehavior

Central Study Contacts

Alexandra MALGOYRE, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 14, 2020

Study Start

October 5, 2020

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations