<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/NCT04464278</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200265</org_study_id>
    <secondary_id>IDRCB 2019-A03287-50</secondary_id>
    <nct_id>NCT04464278</nct_id>
  </id_info>
  <brief_title>Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization</brief_title>
  <acronym>VALCOR</acronym>
  <official_title>Predictive Value of Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization (Suite Care and Rehabilitation)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INSERM UMR S 1136</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The aim of this study is to correlate weight variation as well as body composition with&#xD;
      mortality and unscheduled readmission of geriatric population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Weight loss in obese adults confers health benefits, while weight loss in the elderly is&#xD;
      associated with an increased risk of mortality.&#xD;
&#xD;
      There are a large number of studies associating weight loss and mortality but the&#xD;
      relationships between changes in body composition (ratio between fat mass and lean mass) and&#xD;
      mortality are often contradictory and poorly understood in elderly subject. The aim at this&#xD;
      study is to request at this question.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prognosis value of variation of weight on mortality</measure>
    <time_frame>3 months</time_frame>
    <description>Determination of variation of weight between D0 and D21 after inclusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>3 months</time_frame>
    <description>Monitoring of survival at 3 months after inclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The pprognosis value of variation of weight on unscheduled readmission in SSR</measure>
    <time_frame>Between D0 and D21</time_frame>
    <description>Determination of variation of weight between D0 and D21 after inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unscheduled readmission in SSR</measure>
    <time_frame>during 15 days after the end of hospitalization</time_frame>
    <description>Monitoring of unscheduled readmission during 15 days after the end of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean mass pronostic value</measure>
    <time_frame>3 months after the inclusion</time_frame>
    <description>Determine the prognosis value of variation in lean mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In fat mass pronostic value</measure>
    <time_frame>3 months after the inclusion</time_frame>
    <description>Determine the prognosis value of variation in fat mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fat / lean mass ratio</measure>
    <time_frame>3 months after the inclusion</time_frame>
    <description>Determine the prognosis value of fat / lean mass ratio on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Body Weight Changes</condition>
  <arm_group>
    <arm_group_label>Case group: weight loss ≥ 5%</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: weight loss ≤ 5%</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux&#xD;
        hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥70 years old&#xD;
&#xD;
          -  Hospitalized in SSR for less than 7 days&#xD;
&#xD;
          -  No patient opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with a pacemaker&#xD;
&#xD;
          -  lake of nutritional assessment on admission&#xD;
&#xD;
          -  lake of assessment of autonomy at admission&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient participating in another clinical research&#xD;
&#xD;
          -  Patient for whom a short stay (&lt;21 days) is planned in SSR&#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_official>
    <last_name>Christine FORASASSI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine FORASASSI, MD</last_name>
    <phone>01 40 19 34 14</phone>
    <email>christine.forasassi@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christian AUSSEL, MD</last_name>
    <phone>01 40 19 34 00</phone>
    <email>christian.aussel@aphp.fr</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Geriatric</keyword>
  <keyword>Suite Care and Rehabilitation</keyword>
  <keyword>Body composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</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/NCT04464278
org study id: APHP200265
secondary id: IDRCB 2019-A03287-50
nct id: NCT04464278
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to correlate weight variation as well as body composition with
      mortality and unscheduled readmission of geriatric population
Weight loss in obese adults confers health benefits, while weight loss in the elderly is
      associated with an increased risk of mortality.

      There are a large number of studies associating weight loss and mortality but the
      relationships between changes in body composition (ratio between fat mass and lean mass) and
      mortality are often contradictory and poorly understood in elderly subject. The aim at this
      study is to request at this question.
observational model: Case-Control
time perspective: Prospective
measure: The prognosis value of variation of weight on mortality
time frame: 3 months
description: Determination of variation of weight between D0 and D21 after inclusion
measure: Mortality rate
time frame: 3 months
description: Monitoring of survival at 3 months after inclusion
measure: The pprognosis value of variation of weight on unscheduled readmission in SSR
time frame: Between D0 and D21
description: Determination of variation of weight between D0 and D21 after inclusion
measure: Unscheduled readmission in SSR
time frame: during 15 days after the end of hospitalization
description: Monitoring of unscheduled readmission during 15 days after the end of hospitalization
measure: Lean mass pronostic value
time frame: 3 months after the inclusion
description: Determine the prognosis value of variation in lean mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization
measure: In fat mass pronostic value
time frame: 3 months after the inclusion
description: Determine the prognosis value of variation in fat mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization
measure: fat / lean mass ratio
time frame: 3 months after the inclusion
description: Determine the prognosis value of fat / lean mass ratio on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization
arm group label: Case group: weight loss ≥ 5%
arm group label: Control group: weight loss ≤ 5%
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Christine FORASASSI, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Christine FORASASSI, MD
phone: 01 40 19 34 14
email: christine.forasassi@aphp.fr
last name: Christian AUSSEL, MD
phone: 01 40 19 34 00
email: christian.aussel@aphp.fr
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Body Weight Changes