<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04466800</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_9875_RECOVER-19</org_study_id>
    <nct_id>NCT04466800</nct_id>
  </id_info>
  <brief_title>Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)</brief_title>
  <acronym>RECOVER-19</acronym>
  <official_title>Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Following the acute phase of COVID, some patients may have sequelae, such as breathing&#xD;
      difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation&#xD;
      program associated with personalized nutritional care will improve quality of life, physical&#xD;
      performance and respiratory capacities and will decrease the prevalence of malnutrition among&#xD;
      those patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID&#xD;
      has been responsible for more than 100 000 hospitalizations. Following the acute phase of&#xD;
      this disease, some patients may have sequelae, such as breathing difficulties or&#xD;
      malnutrition. However, the prevalence and intensity of those sequelae still remain unknown.&#xD;
      Thus, a functional and respiratory rehabilitation program associated with personalized&#xD;
      nutritional care may be necessary to improve those patients' prognosis.&#xD;
&#xD;
      This study aims to evaluate the effectiveness of a 4-week rehabilitation program following&#xD;
      the acute phase of COVID. This program includes regular physical activity supervised by a&#xD;
      physical acticity educator, a systematic malnutrition screening and a nutritional follow-up&#xD;
      performed by a dietitian. Patients will be randomized in two groups: rehabilitation program&#xD;
      (intervention group) or usual care (control group). Quality of life, physical performance,&#xD;
      respiratory capacities and nutritional status will be assessed in both groups at inclusion&#xD;
      and one month later (corresponding to the end of the rehabilitation program for the&#xD;
      intervention group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">January 13, 2023</completion_date>
  <primary_completion_date type="Actual">August 29, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multicenter, randomized, comparative, parallel-group trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities</measure>
    <time_frame>1 month</time_frame>
    <description>Number of repeated chair rises during 3 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities</measure>
    <time_frame>1 month</time_frame>
    <description>Aerobic physical capacity using Eval-DM software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities</measure>
    <time_frame>1 month</time_frame>
    <description>Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities</measure>
    <time_frame>3 months</time_frame>
    <description>Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities</measure>
    <time_frame>6 months</time_frame>
    <description>Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities</measure>
    <time_frame>1 month</time_frame>
    <description>Borg scale (from 0 to 10, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities</measure>
    <time_frame>1 month</time_frame>
    <description>Barthel scale (from 0 to 100, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities</measure>
    <time_frame>3 months</time_frame>
    <description>Barthel scale (from 0 to 100, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities</measure>
    <time_frame>6 months</time_frame>
    <description>Barthel scale (from 0 to 100, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>1 month</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>3 months</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>6 months</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>1 month</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>3 months</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>6 months</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>1 month</time_frame>
    <description>Muscular mass by brachial circumference or grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>1 month</time_frame>
    <description>SEFI® score (from 0 to 10, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>3 months</time_frame>
    <description>SEFI® score (from 0 to 10, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria</measure>
    <time_frame>6 months</time_frame>
    <description>SEFI® score (from 0 to 10, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality</measure>
    <time_frame>1 month</time_frame>
    <description>Mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality</measure>
    <time_frame>3 months</time_frame>
    <description>Mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>Proportion of patients returning to a professional activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients returning to a professional activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of patients returning to a professional activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression</measure>
    <time_frame>1 month</time_frame>
    <description>Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression</measure>
    <time_frame>3 months</time_frame>
    <description>Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression</measure>
    <time_frame>6 months</time_frame>
    <description>Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression</measure>
    <time_frame>1 month</time_frame>
    <description>Pichot asthenia scale (from 0 to 32, highers mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression</measure>
    <time_frame>3 months</time_frame>
    <description>Pichot asthenia scale (from 0 to 32, highers mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression</measure>
    <time_frame>6 months</time_frame>
    <description>Pichot asthenia scale (from 0 to 32, highers mean worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption</measure>
    <time_frame>1 month</time_frame>
    <description>Number of consultations with the healthcare professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption</measure>
    <time_frame>3 months</time_frame>
    <description>Number of consultations with the healthcare professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Number of consultations with the healthcare professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption</measure>
    <time_frame>1 month</time_frame>
    <description>Rehospitalisation rate (all causes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption</measure>
    <time_frame>3 months</time_frame>
    <description>Rehospitalisation rate (all causes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Rehospitalisation rate (all causes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Incremental cost-effectiveness ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation</measure>
    <time_frame>6 months</time_frame>
    <description>Incremental cost-effectiveness ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's opinion concerning the rehabilitation program</measure>
    <time_frame>3 months</time_frame>
    <description>Satisfaction questionnaire with open-ended questions (no specific scale is available)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's opinion concerning the rehabilitation program</measure>
    <time_frame>6 months</time_frame>
    <description>Satisfaction questionnaire with open-ended questions (no specific scale is available)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Intervention group_rehabilitation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>multidisciplinary and personalized rehabilitation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention group_rehabilitation program</intervention_name>
    <description>Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician.&#xD;
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.</description>
    <arm_group_label>Intervention group_rehabilitation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
          -  Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2&#xD;
&#xD;
          -  Date of first symptoms of SARS-CoV-2 infection &gt; 4 weeks and &lt; 4 months&#xD;
&#xD;
          -  Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition&#xD;
             beyond the first 4 weeks after COVID, defined as :&#xD;
&#xD;
          -  Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month&#xD;
             before COVID and beyond the first 4 weeks after COVID and/or&#xD;
&#xD;
          -  Asthenia score (Pichot asthenia scale) &gt; 22 beyond the first 4 weeks after COVID, if&#xD;
             patient had no asthenia before COVID (asthenia score &lt;8) and/or&#xD;
&#xD;
          -  Weight loss &gt; 5% within 6 months, comparing minimum weight between the month before&#xD;
             COVID and beyond the first 4 weeks after COVID and/or&#xD;
&#xD;
          -  BMI (Body Mass Index) &lt; 20 (if age &lt; 70 years) or &lt; 22 (if age ≥ 70 years) if BMI&#xD;
             (Body Mass Index) ≥ 20 (if age &lt; 70 years) or ≥ 22 (if age ≥ 70 years) the month&#xD;
             before COVID&#xD;
&#xD;
          -  Patient affiliated to social security system&#xD;
&#xD;
          -  Patient gave written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to undergo a rehabilitation program due to comorbidities, such as major&#xD;
             cardio-vascular disease or severe dementia&#xD;
&#xD;
          -  Patient currently benefiting from physiotherapy sessions, in particular motor and / or&#xD;
             respiratory therapy and / or an exercise re-training and / or respiratory&#xD;
             rehabilitation program&#xD;
&#xD;
          -  Patient living in a residential facility for dependent elderly people&#xD;
&#xD;
          -  Patient not speaking french&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lilian Alix, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aranzazu PEDROSA GONZALEZ, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier de Saint-Brieuc</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christophe POPINEAU, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Bretagne Atlantique</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia THOREUX, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôtel Dieu Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nadia SAIDANI, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier de Cornouaille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôtel Dieu Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cornouaille</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint-Brieuc</name>
      <address>
        <city>Saint-Brieuc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bretagne Atlantique</name>
      <address>
        <city>Vannes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Adapted physical activity</keyword>
  <keyword>Malnutrition</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04466800
org study id: 35RC20_9875_RECOVER-19
nct id: NCT04466800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, randomized, comparative, parallel-group trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life
time frame: 1 month
description: 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)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
time frame: 1 month
description: Number of repeated chair rises during 3 minutes
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities
time frame: 1 month
description: Aerobic physical capacity using Eval-DM software
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
time frame: 1 month
description: Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
time frame: 3 months
description: Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
time frame: 6 months
description: Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities
time frame: 1 month
description: Borg scale (from 0 to 10, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
time frame: 1 month
description: Barthel scale (from 0 to 100, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
time frame: 3 months
description: Barthel scale (from 0 to 100, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities
time frame: 6 months
description: Barthel scale (from 0 to 100, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 1 month
description: Weight loss
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 3 months
description: Weight loss
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 6 months
description: Weight loss
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 1 month
description: Body mass index
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 3 months
description: Body mass index
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 6 months
description: Body mass index
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 1 month
description: Muscular mass by brachial circumference or grip strength
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 1 month
description: SEFI® score (from 0 to 10, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 3 months
description: SEFI® score (from 0 to 10, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria
time frame: 6 months
description: SEFI® score (from 0 to 10, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
time frame: 1 month
description: Mortality rate
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
time frame: 3 months
description: Mortality rate
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality
time frame: 6 months
description: Mortality rate
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 1 month
description: Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 3 months
description: Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 6 months
description: Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 1 month
description: EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 3 months
description: EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 6 months
description: EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 1 month
description: Proportion of patients returning to a professional activity
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 3 months
description: Proportion of patients returning to a professional activity
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life
time frame: 6 months
description: Proportion of patients returning to a professional activity
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
time frame: 1 month
description: Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
time frame: 3 months
description: Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
time frame: 6 months
description: Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
time frame: 1 month
description: Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
time frame: 3 months
description: Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression
time frame: 6 months
description: Pichot asthenia scale (from 0 to 32, highers mean worse outcome)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
time frame: 1 month
description: Number of consultations with the healthcare professionals
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
time frame: 3 months
description: Number of consultations with the healthcare professionals
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
time frame: 6 months
description: Number of consultations with the healthcare professionals
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
time frame: 1 month
description: Rehospitalisation rate (all causes)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
time frame: 3 months
description: Rehospitalisation rate (all causes)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption
time frame: 6 months
description: Rehospitalisation rate (all causes)
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation
time frame: 3 months
description: Incremental cost-effectiveness ratio
measure: Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation
time frame: 6 months
description: Incremental cost-effectiveness ratio
measure: Patient's opinion concerning the rehabilitation program
time frame: 3 months
description: Satisfaction questionnaire with open-ended questions (no specific scale is available)
measure: Patient's opinion concerning the rehabilitation program
time frame: 6 months
description: Satisfaction questionnaire with open-ended questions (no specific scale is available)
arm group label: Intervention group_rehabilitation program
arm group type: Experimental
description: multidisciplinary and personalized rehabilitation program
arm group label: Control group
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Intervention group_rehabilitation program
description: 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.
arm group label: Intervention group_rehabilitation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lilian Alix, Dr
role: Principal Investigator
affiliation: Rennes University Hospital
last name: Aranzazu PEDROSA GONZALEZ, Dr
role: Principal Investigator
affiliation: Centre Hospitalier de Saint-Brieuc
last name: Christophe POPINEAU, Dr
role: Principal Investigator
affiliation: Centre Hospitalier Bretagne Atlantique
last name: Patricia THOREUX, Pr
role: Principal Investigator
affiliation: Hôtel Dieu Paris
last name: Nadia SAIDANI, Dr
role: Principal Investigator
affiliation: Centre Hospitalier de Cornouaille
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No