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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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COVID

Intervention / Treatment
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* Other: Intervention group_rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, comparative, parallel-group trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group_rehabilitation program<br>multidisciplinary and personalized rehabilitation program | Other: Intervention group_rehabilitation program<br>* 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.<br>|
| No Intervention: Control group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, Rehabilitation, Adapted physical activity, Malnutrition