Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19) (RECOVER-19)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    160
  • sponsor
    Rennes University Hospital
Updated on 8 July 2022
body mass index
dyspnea
covid-19
SARS

Summary

Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

Description

In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabilitation program associated with personalized nutritional care may be necessary to improve those patients' prognosis.

This study aims to evaluate the effectiveness of a 4-week rehabilitation program following the acute phase of COVID. This program includes regular physical activity supervised by a physical acticity educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietitian. Patients will be randomized in two groups: rehabilitation program (intervention group) or usual care (control group). Quality of life, physical performance, respiratory capacities and nutritional status will be assessed in both groups at inclusion and one month later (corresponding to the end of the rehabilitation program for the intervention group).

Details
Condition COVID
Treatment Intervention group_rehabilitation program
Clinical Study IdentifierNCT04466800
SponsorRennes University Hospital
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age above 18 years
Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
Date of first symptoms of SARS-CoV-2 infection > 4 weeks and < 4 months
Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as
Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or
Asthenia score (Pichot asthenia scale) > 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score <8) and/or
Weight loss > 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or
BMI (Body Mass Index) < 20 (if age < 70 years) or < 22 (if age ≥ 70 years) if BMI (Body Mass Index) ≥ 20 (if age < 70 years) or ≥ 22 (if age ≥ 70 years) the month before COVID
Patient affiliated to social security system
Patient gave written informed consent

Exclusion Criteria

Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
Patient living in a residential facility for dependent elderly people
Patient not speaking french
Pregnant women
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