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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04356378
Other study ID # PO20055
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2020
Est. completion date January 20, 2022

Study information

Verified date June 2024
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Infection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations. Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management. Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.


Description:

The aim of this study is to study factors associated with physical functional limitations in daily living in patients SARS-CoV2 infected and hospitalized in the acute phase then requiring rehabilitation.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date January 20, 2022
Est. primary completion date August 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria : - patient infected with SARS-CoV2 - in-patient hospitalization in the acute phase because SARS-CoV2 infection - patient requiring rehabilitation after SARS-CoV2 infection acute phase - patient adult, aged more than 18 years old - patient accepting to participate in the study Exclusion criteria : - patient with cognitive disorder (Folstein Mini-Mental State Examination less than 22 on 30 points)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data record
Data record

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical functional limitations Physical functional limitations evaluated using 'sit to stand' test. The patient, seated in a chair without armrest, his arms crossed over his shoulders, should get up and sit down without help of the upper limbs as many times as possible in one minute. 12 months