<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/NCT03271112</url>
  </required_header>
  <id_info>
    <org_study_id>2017/CHU/00</org_study_id>
    <nct_id>NCT03271112</nct_id>
  </id_info>
  <brief_title>Frailty Prevention in Elders From Reunion Island</brief_title>
  <acronym>5P-PILOTE</acronym>
  <official_title>Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre National de la Recherche Scientifique, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Social Security Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</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>
      In Reunion Island, people encounter environmental and social conditions leading to premature&#xD;
      ageing and subsequent frailty. Social welfare has developped exercise programs to promote&#xD;
      physical activity especially for elderly with higher risk factors of frailty, including low&#xD;
      incomes.&#xD;
&#xD;
      The study evaluates the potent benefit effect of such exercise program on physical&#xD;
      performance and frailty improvement in seniors from Reunion Island. All seniors participate&#xD;
      to a 12-weeks exercise program especially dedicated to this targeted population needs and&#xD;
      ability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regular physical activity has been shown to slow down sarcopenia, and increase strengh in&#xD;
      elders. Nevertheless, senior with low incomes do not usually have access to physical activity&#xD;
      areas.&#xD;
&#xD;
      Social partners are in close relationship with these elders and could promote free exercise&#xD;
      programs dedicated to elders classified as &quot;GIR5-6&quot; according to the French scale &quot;AGIRR&quot;.&#xD;
      The AGIRR scale takes into account several criteria allowing the evaluation of the level of&#xD;
      autonomy. The level of autonomy is closely related to frailty and could be reversed since&#xD;
      elders have not reach a dependant-state. The &quot;GIR5-6&quot; level means that elderly people are&#xD;
      still not dependant but exhibit several frailty risk factors.&#xD;
&#xD;
      The level of frailty and the physical performance of the participants is assessed by standard&#xD;
      geriatric evaluation before the 12-wks exercice program. The improvement of the physical&#xD;
      performance is assessed after he 12-wks exercice program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">July 4, 2019</completion_date>
  <primary_completion_date type="Actual">May 7, 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>
    <intervention_model_description>Pilote study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical performance improvement</measure>
    <time_frame>Physical performance improvement from baseline to 12 wks</time_frame>
    <description>Physical performance is assessed as as balance, walk and strength improvement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>SF36 improvement from baseline to 12 wks</time_frame>
    <description>Improvement of quality of life assessed by SF36 v1 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Exercise program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participation to the 12-wks exercise program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise program</intervention_name>
    <description>Measurement of physical performance before and after the 12 wks-exercice program</description>
    <arm_group_label>Exercise program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Retired&#xD;
&#xD;
          -  with an autonomy level corresponding to the &quot;GIR 5-6&quot; level of the French &quot;AGIRR&#xD;
             scale&quot;&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical activity prohibited&#xD;
&#xD;
          -  under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marc EYCHENE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hpospitalier Universitaire de La REUNION</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Reunion Island</name>
      <address>
        <city>Saint-joseph</city>
        <country>Réunion</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Réunion</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</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>Frailty</mesh_term>
  </condition_browse>
  <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/NCT03271112
org study id: 2017/CHU/00
nct id: NCT03271112
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Reunion Island, people encounter environmental and social conditions leading to premature
      ageing and subsequent frailty. Social welfare has developped exercise programs to promote
      physical activity especially for elderly with higher risk factors of frailty, including low
      incomes.

      The study evaluates the potent benefit effect of such exercise program on physical
      performance and frailty improvement in seniors from Reunion Island. All seniors participate
      to a 12-weeks exercise program especially dedicated to this targeted population needs and
      ability.
Regular physical activity has been shown to slow down sarcopenia, and increase strengh in
      elders. Nevertheless, senior with low incomes do not usually have access to physical activity
      areas.

      Social partners are in close relationship with these elders and could promote free exercise
      programs dedicated to elders classified as "GIR5-6" according to the French scale "AGIRR".
      The AGIRR scale takes into account several criteria allowing the evaluation of the level of
      autonomy. The level of autonomy is closely related to frailty and could be reversed since
      elders have not reach a dependant-state. The "GIR5-6" level means that elderly people are
      still not dependant but exhibit several frailty risk factors.

      The level of frailty and the physical performance of the participants is assessed by standard
      geriatric evaluation before the 12-wks exercice program. The improvement of the physical
      performance is assessed after he 12-wks exercice program.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilote study
primary purpose: Prevention
masking: None (Open Label)
measure: Physical performance improvement
time frame: Physical performance improvement from baseline to 12 wks
description: Physical performance is assessed as as balance, walk and strength improvement
measure: Quality of life score
time frame: SF36 improvement from baseline to 12 wks
description: Improvement of quality of life assessed by SF36 v1 questionnaire
arm group label: Exercise program
arm group type: Other
description: Participation to the 12-wks exercise program
intervention type: Other
intervention name: Exercise program
description: Measurement of physical performance before and after the 12 wks-exercice program
arm group label: Exercise program
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marc EYCHENE, MD
role: Principal Investigator
affiliation: Centre Hpospitalier Universitaire de La REUNION
facility: 
country: Réunion
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No