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

Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

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.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Other: Intervention group_rehabilitation program

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hotel Dieu Paris
  • Quimper, France
    • Centre Hospitalier de Cornouaille
  • Rennes, France
    • CHU Rennes
  • Saint-Brieuc, France
    • Centre Hospitalier de Saint-Brieuc
  • Vannes, France
    • Centre Hospitalier Bretagne Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group_rehabilitation program; multidisciplinary and personalized rehabilitation program	Other: Intervention group_rehabilitation program; Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician. Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life	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)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities	Number of repeated chair rises during 3 minutes	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities	Aerobic physical capacity using Eval-DM software	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities	Borg scale (from 0 to 10, highers scores mean worse outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	Barthel scale (from 0 to 100, highers scores mean worse outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	Barthel scale (from 0 to 100, highers scores mean worse outcome)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities	Barthel scale (from 0 to 100, highers scores mean worse outcome)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Weight loss	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Weight loss	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Weight loss	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Body mass index	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Body mass index	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Body mass index	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	Muscular mass by brachial circumference or grip strength	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	SEFI® score (from 0 to 10, highers scores mean better outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	SEFI® score (from 0 to 10, highers scores mean better outcome)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria	SEFI® score (from 0 to 10, highers scores mean better outcome)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	Mortality rate	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	Mortality rate	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality	Mortality rate	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Proportion of patients returning to a professional activity	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Proportion of patients returning to a professional activity	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life	Proportion of patients returning to a professional activity	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression	Pichot asthenia scale (from 0 to 32, highers mean worse outcome)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Number of consultations with the healthcare professionals	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Number of consultations with the healthcare professionals	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Number of consultations with the healthcare professionals	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Rehospitalisation rate (all causes)	1 month
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Rehospitalisation rate (all causes)	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption	Rehospitalisation rate (all causes)	6 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation	Incremental cost-effectiveness ratio	3 months
Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation	Incremental cost-effectiveness ratio	6 months
Patient's opinion concerning the rehabilitation program	Satisfaction questionnaire with open-ended questions (no specific scale is available)	3 months
Patient's opinion concerning the rehabilitation program	Satisfaction questionnaire with open-ended questions (no specific scale is available)	6 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Lilian Alix, Dr, Rennes University Hospital; Principal Investigator: Aranzazu PEDROSA GONZALEZ, Dr, Centre Hospitalier de Saint-Brieuc; Principal Investigator: Christophe POPINEAU, Dr, Centre Hospitalier Bretagne Atlantique; Principal Investigator: Patricia THOREUX, Pr, Hotel Dieu Paris; Principal Investigator: Nadia SAIDANI, Dr, Centre Hospitalier de Cornouaille

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; COVID; Malnutrition; Adapted physical activity
• Other Study ID Numbers: 35RC20_9875_RECOVER-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No