CAPACoV19: Long Term Physical Functional Limitations in Daily Living in SARS-CoV2 Infected Patients Hospitalized in the Acute Phase Then Requiring Rehabilitation

Sponsor
CHU de Reims (Other)
Overall Status
Unknown status
CT.gov ID
NCT04356378
Collaborator
(none)
300
1
21
14.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data record

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Jun 2, 2020
Anticipated Primary Completion Date :
Oct 2, 2021
Anticipated Study Completion Date :
Mar 2, 2022

Arms and Interventions

Arm Intervention/Treatment
"infection with coronavirus SARS-CoV2" group

"SARS-CoV2 infected patients" group: in-patient in the acute phase then requiring rehabilitation.

Other: Data record
Data record

Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damien JOLLY Reims France

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT04356378
Other Study ID Numbers:
  • PO20055
First Posted:
Apr 22, 2020
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CHU de Reims
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2020