<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/NCT03836911</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0006</org_study_id>
    <nct_id>NCT03836911</nct_id>
    <nct_alias>NCT03694795</nct_alias>
  </id_info>
  <brief_title>Effects of a Serious Game With Elderly People</brief_title>
  <official_title>Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Assessment of the effect of a 12 weeks serious game based exercises program on physical&#xD;
      performance in older adults living in nursing homes, in comparison with a control group that&#xD;
      benefits from a classical exercise training program including balance, muscle strengthening&#xD;
      and walking exercises with the same duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent reviews of the literature have shown that exergames may have interest in balance&#xD;
      rehabilitation, physical performance maintenance, and fall prevention in community dwelling&#xD;
      older adults with neurodegenerative disease or at risk of fall. These reviews also show&#xD;
      however that classical exergames are not adapted for rehabilitation of patients with&#xD;
      functional limitations, which could explain their relatively moderate benefits in those&#xD;
      patients.&#xD;
&#xD;
      To overcome this lack, a serious game has been co-developed with medical to be adapted to the&#xD;
      specific needs and characteristics of nursing home residents In this study , the&#xD;
      investigators propose to compare the effects on physical performance, falls incidence, and&#xD;
      quality of life of a 12-weeks serious game based exercise program and a classical exercises&#xD;
      program&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2024</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Physical Performance Baterry (SPPB)</measure>
    <time_frame>3 months</time_frame>
    <description>Short Physical Performance Baterry (SPPB) at baseline (T0) and at 3 months.The Short Physical Performance Battery (SPPB) is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test. This test makes it possible to evaluate the physical performance of an individual.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Baterry (SPPB)</measure>
    <time_frame>6 months</time_frame>
    <description>SPPB score at 6 months.The Short Physical Performance Battery (SPPB) is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test. This test makes it possible to evaluate the physical performance of an individual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of fall</measure>
    <time_frame>3 months</time_frame>
    <description>incidence of fall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of fall</measure>
    <time_frame>6 months</time_frame>
    <description>incidence of fall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>at baseline (T0)</time_frame>
    <description>Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>3 months</time_frame>
    <description>Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>At inclusion</time_frame>
    <description>Mini Mental State Examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>3 months</time_frame>
    <description>Mini Mental State Examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction evaluation</measure>
    <time_frame>At inclusion</time_frame>
    <description>Lickert Scale at inclusion.A Likert scale is a psychometric tool to measure an attitude in individuals.The scale contains for each item a graduation generally comprising five or seven answer choices that qualify the degree of agreement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>Lickert Scale at inclusion.A Likert scale is a psychometric tool to measure an attitude in individuals.The scale contains for each item a graduation generally comprising five or seven answer choices that qualify the degree of agreement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the quality of life</measure>
    <time_frame>At inclusion</time_frame>
    <description>SF12 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>SF12 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">234</enrollment>
  <condition>Functional Autonomy</condition>
  <arm_group>
    <arm_group_label>serious game</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classic program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the effect on physical performance of a personalized, 12-weeks rehabilitation program using a classical exercise program in older subjects living in a nursing home</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>serious game</intervention_name>
    <description>Effect of serious game on elderly in comparison of the physical activity adapted meeting</description>
    <arm_group_label>serious game</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>classic program</intervention_name>
    <description>Effect of serious game on elderly in comparison of the physical activity adapted meeting</description>
    <arm_group_label>Classic program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older adults aged 65 and over, living in nursing homes and able to walk without&#xD;
             technical assistance and sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with cognitive impairments (MMSE &lt; 14) or with conditions that&#xD;
             contra-indicate the involvement in a rehabilitation program for medical or ethics&#xD;
             reasons; subjects with a history of seizure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chokri BOUBAKRI, PhD</last_name>
    <phone>0467335502</phone>
    <email>c-boubakri@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>EHPAD Les Aigueillières</name>
      <address>
        <city>Montferrier Sur Lez</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel BOSSE, PhD</last_name>
      <email>aigmedecin@maison-retraite-montpellier.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>EHPAD Françoise Gauffier CCAS de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aline PEREZ-BERHO, PhD</last_name>
      <email>aline.perez@ccas.montpellier.fr</email>
    </contact>
    <investigator>
      <last_name>Aline PEREZ-BERHO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ehpad Maison de Famille</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hélène KAZARIAN, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Hélène KAZARIAN, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Pierre Laroque CCAS de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francoise VANDEVENTER, PhD</last_name>
      <email>francoise.arnaud-vandeventer@ccas.montpellier.fr</email>
    </contact>
    <investigator>
      <last_name>Francoise VANDEVENTER, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Le Barry</name>
      <address>
        <city>Muret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel BISMUTH, PhD</last_name>
      <email>mbismuth@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Michel BISMUTH, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Marie-Antoinette</name>
      <address>
        <city>Muret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe ROUX, PhD</last_name>
      <email>proux@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe v, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Résidence La Camargue, Nimes (Groue Orpéa)</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian PAVLOFF, PhD</last_name>
      <email>c.pavloff@orpea.net</email>
    </contact>
    <investigator>
      <last_name>Christian PAVLOFF, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Résidence Château Notre Dame (Groupe Orpéa)</name>
      <address>
        <city>Parignargues</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Hélène JAEN-GRAS, PhD</last_name>
      <email>medcoo.notredame@orpea.net</email>
    </contact>
    <investigator>
      <last_name>Marie-Hélène JAEN-GRAS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Belleviste</name>
      <address>
        <city>Saint-Gély-du-Fesc</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Florence CHAPOUTOT-CIURANA, PhD</last_name>
      <email>florence.chapoutot@belleviste-stgely.fr</email>
    </contact>
    <investigator>
      <last_name>Florence CHAPOUTOT-CIURANA, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Caroline Baron</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie Charlotte DEWAS DE MAUPEOU, PhD</last_name>
      <email>cdemaupeou@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Sophie Charlotte DEWAS DE MAUPEOU, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ehpad La Cotonniere</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain SAUNE, PhD</last_name>
      <email>asaune@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Alain SAUNE, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD LA houlette</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Béatrice IZQUIERDO, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Béatrice IZQUIERDO, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ehpad Le Bois Vert</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frederic POZZOBON, PhD</last_name>
      <email>ccointault@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Frederic POZZOBON, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ehpad Pastelliere</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Luc MOUSSET, PhD</last_name>
      <email>jlmousset@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Luc MOUSSET, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EHPAD Le Grand Marquisat</name>
      <address>
        <city>Tournefeuille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadège GUYON SAINT JEAN, PhD</last_name>
      <email>nguyon@edenis.fr</email>
    </contact>
    <investigator>
      <last_name>Nadège GUYON SAINT JEAN, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 17, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Institutionalized olders adults</keyword>
  <keyword>SERIOUS GAME</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/NCT03836911
org study id: RECHMPL18_0006
nct id: NCT03836911
nct alias: NCT03694795
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessment of the effect of a 12 weeks serious game based exercises program on physical
      performance in older adults living in nursing homes, in comparison with a control group that
      benefits from a classical exercise training program including balance, muscle strengthening
      and walking exercises with the same duration.
Recent reviews of the literature have shown that exergames may have interest in balance
      rehabilitation, physical performance maintenance, and fall prevention in community dwelling
      older adults with neurodegenerative disease or at risk of fall. These reviews also show
      however that classical exergames are not adapted for rehabilitation of patients with
      functional limitations, which could explain their relatively moderate benefits in those
      patients.

      To overcome this lack, a serious game has been co-developed with medical to be adapted to the
      specific needs and characteristics of nursing home residents In this study , the
      investigators propose to compare the effects on physical performance, falls incidence, and
      quality of life of a 12-weeks serious game based exercise program and a classical exercises
      program
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Short Physical Performance Baterry (SPPB)
time frame: 3 months
description: Short Physical Performance Baterry (SPPB) at baseline (T0) and at 3 months.The Short Physical Performance Battery (SPPB) is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test. This test makes it possible to evaluate the physical performance of an individual.
measure: Short Physical Performance Baterry (SPPB)
time frame: 6 months
description: SPPB score at 6 months.The Short Physical Performance Battery (SPPB) is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test. This test makes it possible to evaluate the physical performance of an individual.
measure: incidence of fall
time frame: 3 months
description: incidence of fall
measure: incidence of fall
time frame: 6 months
description: incidence of fall
measure: Balance
time frame: at baseline (T0)
description: Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
measure: Balance
time frame: 3 months
description: Timed Up and Go Test, Tinetti Test and unipodal standing in simple and dual-task
measure: Cognition
time frame: At inclusion
description: Mini Mental State Examination
measure: Cognition
time frame: 3 months
description: Mini Mental State Examination
measure: Satisfaction evaluation
time frame: At inclusion
description: Lickert Scale at inclusion.A Likert scale is a psychometric tool to measure an attitude in individuals.The scale contains for each item a graduation generally comprising five or seven answer choices that qualify the degree of agreement
measure: Satisfaction evaluation
time frame: 3 months
description: Lickert Scale at inclusion.A Likert scale is a psychometric tool to measure an attitude in individuals.The scale contains for each item a graduation generally comprising five or seven answer choices that qualify the degree of agreement
measure: Evaluation of the quality of life
time frame: At inclusion
description: SF12 questionnaire
measure: Evaluation of the quality of life
time frame: 3 months
description: SF12 questionnaire
arm group label: serious game
arm group type: Active Comparator
description: the effect on physical performance of a personalized, 12-weeks rehabilitation program using a serious game
arm group label: Classic program
arm group type: Other
description: the effect on physical performance of a personalized, 12-weeks rehabilitation program using a classical exercise program in older subjects living in a nursing home
intervention type: Other
intervention name: serious game
description: Effect of serious game on elderly in comparison of the physical activity adapted meeting
arm group label: serious game
intervention type: Other
intervention name: classic program
description: Effect of serious game on elderly in comparison of the physical activity adapted meeting
arm group label: Classic program
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Chokri BOUBAKRI, PhD
phone: 0467335502
email: c-boubakri@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: France
responsible party type: Sponsor
sharing ipd: No