Infection With Coronavirus SARS-CoV2 Clinical Trial
— CAPACoV19Official title:
Long Term Physical Functional Performance in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation: a Multicentric Observational Study
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 |
Verified date | June 2024 |
Source | CHU de Reims |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Damien JOLLY | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
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 |