Long Term Physical Functional Limitations in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation
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StatusRecruiting
Sponsors
CHU de Reims
CLINICAL TRIAL: NCT04356378
BioSeek: nct04356378
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 04/16/2020 |
| Estimated Enrollment Submitted: | 04/20/2020 |
| First Posted: | 04/21/2020 |
| Last Update Submitted: | 06/07/2020 |
| Last Update Posted: | 06/10/2020 |
| Actual Study Start Date: | 06/01/2020 |
| Estimated Primary Completion Date: | 10/01/2021 |
| Estimated Study Completion Date: | 03/01/2022 |
Condition or disease
Infection With Coronavirus SARS-CoV2
Intervention/treatment
Other: "infection with coronavirus SARS-CoV2" group
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| "infection with coronavirus SARS-CoV2" group "SARS-CoV2 infected patients" group: in-patient in the acute phase then requiring rehabilitation. | Other: "infection with coronavirus SARS-CoV2" group Data record |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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) |
Outcome
Primary Outcome Measures
1. Physical functional limitations [12 months]
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.
