Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04548505
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2020-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recovery of Exertion Ability Following COVID-19 Infection in Military Staff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-04-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of the decrease in aerobic performance on return to work', 'timeFrame': 'Up to 18 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity'], 'conditions': ['SARS-CoV Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).\n\nBased 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be an active military personnel of the Paris Fire Brigade\n* Be at least 18 years of age\n* Benefiting or having benefited from the post-COVID medical care provided by the French Armed Forces Health Service\n\nExclusion Criteria:\n\n* Be under 18 years of age'}, 'identificationModule': {'nctId': 'NCT04548505', 'acronym': 'CovEx', 'briefTitle': 'Recovery of Exertion Ability Following COVID-19 Infection in Military Staff', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Recovery of Exertion Ability Following COVID-19 Infection in Military Staff', 'orgStudyIdInfo': {'id': '2020-COVID19-30'}, 'secondaryIdInfos': [{'id': '2020-A02140-39', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91223', 'city': 'Brétigny-sur-Orge', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandra MALGOYRE, MD, PhD', 'role': 'CONTACT', 'email': 'alexandra.malgoyre@intradef.gouv.fr', 'phone': '169631317', 'phoneExt': '+33'}], 'facility': 'Institut de Recherche Biomédicale des Armées', 'geoPoint': {'lat': 48.61135, 'lon': 2.30593}}], 'centralContacts': [{'name': 'Alexandra MALGOYRE, MD, PhD', 'role': 'CONTACT', 'email': 'alexandra.malgoyre@intradef.gouv.fr', 'phone': '169631317', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}