Clinical trial NCT04466800: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)
Official title: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Keywords: COVID
Rehabilitation
Adapted physical activity
Malnutrition
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, comparative, parallel-group trial
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life
timeFrame: 1 month
Secondary outcomes:
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
timeFrame: 1 month
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
timeFrame: 6 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation
timeFrame: 3 months
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation
timeFrame: 6 months
measure: Patient's opinion concerning the rehabilitation program
timeFrame: 3 months
measure: Patient's opinion concerning the rehabilitation program
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôtel Dieu Paris
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Rennes
country: France
facility: CHU Rennes
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
affiliation: Rennes University Hospital
name: Lilian Alix, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Saint-Brieuc
name: Aranzazu PEDROSA GONZALEZ, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Bretagne Atlantique
name: Christophe POPINEAU, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôtel Dieu Paris
name: Patricia THOREUX, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Cornouaille
name: Nadia SAIDANI, Dr
role: PRINCIPAL_INVESTIGATOR
References: