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

Rennes University Hospital

Status: Completed

Conditions: COVID

Treatments: Other: Intervention group_rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04466800

35RC20_9875_RECOVER-19

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention group_rehabilitation program

Experimental group

Description:

multidisciplinary and personalized rehabilitation program

Treatment:

Other: Intervention group_rehabilitation program

Control group

No Intervention group

Description:

Usual care of each site, including delivery of an information sheet concerning recommended physical activity (based on WHO recommendations) and nutrition. One month after inclusion, patients of this group will be offered a rehabilitation program (as described in the intervention group, but with only one session with a physical activity educator at home) and one dietitian consultation.