<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/NCT03834103</url>
  </required_header>
  <id_info>
    <org_study_id>MED-01-2018</org_study_id>
    <nct_id>NCT03834103</nct_id>
  </id_info>
  <brief_title>Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia</brief_title>
  <acronym>FREESARC</acronym>
  <official_title>Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Mutualiste Montsouris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Mutualiste Montsouris</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Loss of autonomy among elderly during and after hospitalisation is a well-known problem.&#xD;
      Patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not&#xD;
      to recover their previous autonomy.&#xD;
&#xD;
      Studies have shown that physical exercise, especially resistance exercises, is the most&#xD;
      efficient known treatment of sarcopenia. Several institution-based rehabilitation programs&#xD;
      had been implemented in this purpose.&#xD;
&#xD;
      On the other hand, some studies have shown that home-based self-rehabilitation can be as&#xD;
      efficient as institution-based rehabilitation, for example in stroke, cardiac failure and&#xD;
      COPD rehabilitation.&#xD;
&#xD;
      The investigators propose to set up a home-based self-rehabilitation program to fight against&#xD;
      sarcopenia and hence increasing autonomy among elderly. This study aimed to establish the&#xD;
      feasibility of such a program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 9, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients</measure>
    <time_frame>3 months</time_frame>
    <description>Measured from program adherence using a patient notebook</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients</measure>
    <time_frame>3 months</time_frame>
    <description>Measured from patient satisfaction using a satisfaction scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients</measure>
    <time_frame>3 months</time_frame>
    <description>Measured from medical time required by phone call</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscular status evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Change in muscle mass measured with Bio-Impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular status evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Performance in muscle mass measured with Short Physical Performance Battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular status evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Force in muscle mass measured with Grip test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy degree evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Change in autonomy measured with Barthel Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Change in quality of life measured with Médical Outcomes Study Short Form 36</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Arm 1: Self-rehabilitation arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Self-rehabilitation arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-rehabilitation program and protein supplement</intervention_name>
    <description>Participants follow a home-based self-rehabilitation program consisting of the realisation of a set of physical exercises using an elastic band. The exercises have to be performed 3 times a week, and are associated with a protein supplementation.&#xD;
The rehabilitation follow-up by the physician is planned once a week, by phone, and with face-to-face appointments at inclusion, 6 weeks and 3 months follow-up.</description>
    <arm_group_label>Arm 1: Self-rehabilitation arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 70 or older&#xD;
&#xD;
          -  Non-institutionnalised patients&#xD;
&#xD;
          -  Patients suffering of sarcopenia during hospitalisation (assessed by the Short&#xD;
             Physical Performance Battery, Bio-Impedance analysis and griptest)&#xD;
&#xD;
          -  Patients hospitalised in the service of Internal Medicine of Institut Mutualiste&#xD;
             Montsouris&#xD;
&#xD;
          -  Patients returning at home after hospitalisation&#xD;
&#xD;
          -  Patients who gave their written consent&#xD;
&#xD;
          -  Patients who benefits from a social security coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from a severe medical condition not allowing them to follow a&#xD;
             physical exercise program&#xD;
&#xD;
          -  Palliative care patients&#xD;
&#xD;
          -  Patients without the musculo-squelettic capacity to follow the program : 4/4 on seated&#xD;
             postural stability scale ; no motor deficit on lower limb muscular testing ;&#xD;
             quadricipital locking when standing&#xD;
&#xD;
          -  Patients with severe cognitive disorders (according to MMSE score adapted to&#xD;
             socio-cultural level and age)&#xD;
&#xD;
          -  Patients who live more than 150 km away&#xD;
&#xD;
          -  Patients following specific physiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Isabelle SAURET</last_name>
    <phone>+33 1 56 61 67 05</phone>
    <email>isabelle.sauret@imm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caroline RIX</last_name>
    <phone>+33 1 56 61 63 71</phone>
    <email>caroline.rix@imm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle SAURET</last_name>
      <phone>+ 33 1 56 61 67 05</phone>
      <email>isabelle.sauret@imm.fr</email>
    </contact>
    <contact_backup>
      <last_name>Caroline RIX</last_name>
      <phone>+ 33 1 56 61 63 71</phone>
      <email>caroline.rix@imm.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Martine GAYRAUD LARMIGNAT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03834103
org study id: MED-01-2018
nct id: NCT03834103
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Loss of autonomy among elderly during and after hospitalisation is a well-known problem.
      Patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not
      to recover their previous autonomy.

      Studies have shown that physical exercise, especially resistance exercises, is the most
      efficient known treatment of sarcopenia. Several institution-based rehabilitation programs
      had been implemented in this purpose.

      On the other hand, some studies have shown that home-based self-rehabilitation can be as
      efficient as institution-based rehabilitation, for example in stroke, cardiac failure and
      COPD rehabilitation.

      The investigators propose to set up a home-based self-rehabilitation program to fight against
      sarcopenia and hence increasing autonomy among elderly. This study aimed to establish the
      feasibility of such a program.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
time frame: 3 months
description: Measured from program adherence using a patient notebook
measure: Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
time frame: 3 months
description: Measured from patient satisfaction using a satisfaction scale
measure: Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
time frame: 3 months
description: Measured from medical time required by phone call
measure: Muscular status evaluation
time frame: 3 months
description: Change in muscle mass measured with Bio-Impedance analysis
measure: Muscular status evaluation
time frame: 3 months
description: Performance in muscle mass measured with Short Physical Performance Battery
measure: Muscular status evaluation
time frame: 3 months
description: Force in muscle mass measured with Grip test
measure: Autonomy degree evaluation
time frame: 3 months
description: Change in autonomy measured with Barthel Index
measure: Quality of life evaluation
time frame: 3 months
description: Change in quality of life measured with Médical Outcomes Study Short Form 36
arm group label: Arm 1: Self-rehabilitation arm
arm group type: Other
description: Self-rehabilitation arm
intervention type: Behavioral
intervention name: Self-rehabilitation program and protein supplement
description: Participants follow a home-based self-rehabilitation program consisting of the realisation of a set of physical exercises using an elastic band. The exercises have to be performed 3 times a week, and are associated with a protein supplementation.
The rehabilitation follow-up by the physician is planned once a week, by phone, and with face-to-face appointments at inclusion, 6 weeks and 3 months follow-up.
arm group label: Arm 1: Self-rehabilitation arm
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle SAURET
phone: +33 1 56 61 67 05
email: isabelle.sauret@imm.fr
last name: Caroline RIX
phone: +33 1 56 61 63 71
email: caroline.rix@imm.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sarcopenia