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

Not Applicable

Completed

• Conditions: COVID
• Interventions: Other: Intervention group_rehabilitation program

• Registration Number: NCT04466800
• Lead Sponsor: Rennes University Hospital

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Study Start: 2020-07-30
• Primary Completion: 2022-08-29
• Status Verified: 2023-01
• Study Completion: 2023-01-13
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group_rehabilitation program	Intervention group_rehabilitation program	multidisciplinary and personalized rehabilitation program

Primary Outcome Measures

Name	Time	Method
Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life	1 month	Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)

Secondary Outcome Measures

Name	Time	Method
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	6 months	Mortality rate
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	1 month	Borg scale (from 0 to 10, highers scores mean worse outcome)
Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation	6 months	Incremental cost-effectiveness ratio
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	6 months	Proportion of patients returning to a professional activity
Patient's opinion concerning the rehabilitation program	6 months	Satisfaction questionnaire with open-ended questions (no specific scale is available)
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	6 months	SEFI® score (from 0 to 10, highers scores mean better outcome)
Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities	1 month	Aerobic physical capacity using Eval-DM software
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	6 months	Barthel scale (from 0 to 100, highers scores mean worse outcome)
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	6 months	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	6 months	Rehospitalisation rate (all causes)

Trial Locations

Locations (5)

Hôtel Dieu Paris; 🇫🇷 Paris, France

CHU Rennes; 🇫🇷 Rennes, France

Centre Hospitalier de Saint-Brieuc; 🇫🇷 Saint-Brieuc, France

Centre Hospitalier de Cornouaille; 🇫🇷 Quimper, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France