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

NCT04356378 | Completed

• 1 other identifier: PO20055
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection With Coronavirus SARS-CoV2

Keywords

observational study; cohort study; coronavirus infections; respiratory distress syndrome; adult; rehabilitation; physical functional performance; long term care; exercise tolerance; clinical study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

"infection with coronavirus SARS-CoV2" group

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

Other: Data record

Interventions

Data record OTHER

Data record

"infection with coronavirus SARS-CoV2" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SARS-CoV2 infected patients, hospitalized in the acute phase then requiring rehabilitation follow-up.

You may qualify if:

• 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

You may not qualify if:

• patient with cognitive disorder (Folstein Mini-Mental State Examination less than 22 on 30 points)

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Distress Syndrome

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 22, 2020
• Study Start: June 2, 2020
• Primary Completion: August 20, 2021
• Study Completion: January 20, 2022
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FR (1)