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

NCT ID: NCT04466800

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2023-01-13

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).

Conditions

COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group_rehabilitation program

multidisciplinary and personalized rehabilitation program

Group Type: EXPERIMENTAL

Intervention group_rehabilitation program

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lilian Alix, Dr

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Aranzazu PEDROSA GONZALEZ, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Saint-Brieuc

Christophe POPINEAU, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Bretagne Atlantique

Patricia THOREUX, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôtel Dieu Paris

Nadia SAIDANI, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Cornouaille

Locations

Hôtel Dieu Paris

Paris, , France

Centre Hospitalier de Cornouaille

Quimper, , France

CHU Rennes

Rennes, , France

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, , France

Centre Hospitalier Bretagne Atlantique

Vannes, , France

Countries

France

Other Identifiers

35RC20_9875_RECOVER-19

Identifier Type: -

Identifier Source: org_study_id