<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/NCT04436315</url>
  </required_header>
  <id_info>
    <org_study_id>082020</org_study_id>
    <nct_id>NCT04436315</nct_id>
  </id_info>
  <brief_title>Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder</brief_title>
  <official_title>Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Davy Vancampfort</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</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>
      This study evaluates the feasibility of the intervention and the study design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study evaluates the feasibility of the intervention and the study design. Furthermore,&#xD;
      it investigates the effects of an exergame training including strength, balance, cognitive&#xD;
      and pelvic floor muscle training. The main risk in this study is related to potential&#xD;
      accidents/falls during the training (and not mainly to the data acquisition procedures). But&#xD;
      as the difficulty of the training game is adaptive, the participants will always be&#xD;
      challenged on an appropriate level for their physical condition. Furthermore, before and&#xD;
      after the training period, several low risk measurements are conducted. This study&#xD;
      contributes to fundamental research investigating how multicomponent exergame training&#xD;
      influence physical and cognitive functions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>2 years</time_frame>
    <description>Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor functions</measure>
    <time_frame>2 years</time_frame>
    <description>Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery&#xD;
1 - Minute Sit to Stand Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive functions</measure>
    <time_frame>2 years</time_frame>
    <description>Montréal Cognitive Assessment Mini-Mental State Examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental health</measure>
    <time_frame>2 years</time_frame>
    <description>Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Exergame</condition>
  <condition>Major Neurocognitive Disorder</condition>
  <condition>Long-term Care Facility</condition>
  <condition>Nursing Home</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exergame intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Active control condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Motor-cognitive training device</intervention_name>
    <description>Motor-cognitive training device</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Vitaal exergame</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active control condition</intervention_name>
    <description>Physical activity program</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Physical therapy program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 60+ years&#xD;
&#xD;
          -  Living in residency &quot;de Wingerd&quot; in Leuven (at least two weeks here)&#xD;
&#xD;
          -  Being able to straight for minimal 10 minutes without aids&#xD;
&#xD;
          -  Visual acuity with correction sufficient to see on a TV screen&#xD;
&#xD;
          -  diagnosed with major neurocognitive disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mobility impairments that don't allow to play the exergame&#xD;
&#xD;
          -  Any unstable cardiovascular or other health condition which according to the American&#xD;
             College of Sports Medicine Standards might lead to unsafe participation (e.g. recent&#xD;
             cardiac infarction, uncontrolled diabetes or hypertension)&#xD;
&#xD;
          -  Orthopaedic or neurological diseases that prevent exergame training&#xD;
&#xD;
          -  Rapidly progressive or terminal illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nathalie Swinnen</last_name>
    <phone>+3216348215</phone>
    <email>nathalie.swinnen@kuleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Davy Vancampfort</last_name>
    <phone>+3216376564</phone>
    <email>davy.vancampfort@kuleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>De Wingerd</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathalie Swinnen</last_name>
      <phone>+3216348215</phone>
      <email>nathalie.swinnen@kuleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Davy Vancampfort</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Neurocognitive Disorders</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/NCT04436315
org study id: 082020
nct id: NCT04436315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility of the intervention and the study design.
This study evaluates the feasibility of the intervention and the study design. Furthermore,
      it investigates the effects of an exergame training including strength, balance, cognitive
      and pelvic floor muscle training. The main risk in this study is related to potential
      accidents/falls during the training (and not mainly to the data acquisition procedures). But
      as the difficulty of the training game is adaptive, the participants will always be
      challenged on an appropriate level for their physical condition. Furthermore, before and
      after the training period, several low risk measurements are conducted. This study
      contributes to fundamental research investigating how multicomponent exergame training
      influence physical and cognitive functions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Feasibility
time frame: 2 years
description: Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety
measure: Motor functions
time frame: 2 years
description: Recruitment rate Adherence Attrition Time management of the assessments during pre-/post-measurements and the intervention Safety Short Physical Performance Battery
1 - Minute Sit to Stand Test
measure: Cognitive functions
time frame: 2 years
description: Montréal Cognitive Assessment Mini-Mental State Examination
measure: Mental health
time frame: 2 years
description: Cornell Scale for Depression in Dementia Neuropsychiatric Inventory Dementia Quality of Life
arm group label: Intervention
arm group type: Experimental
description: Exergame intervention
arm group label: Control
arm group type: Sham Comparator
description: Active control condition
intervention type: Device
intervention name: Motor-cognitive training device
description: Motor-cognitive training device
arm group label: Intervention
other name: Vitaal exergame
intervention type: Other
intervention name: Active control condition
description: Physical activity program
arm group label: Control
other name: Physical therapy program
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Nathalie Swinnen
phone: +3216348215
email: nathalie.swinnen@kuleuven.be
last name: Davy Vancampfort
phone: +3216376564
email: davy.vancampfort@kuleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: KU Leuven
investigator full name: Davy Vancampfort
investigator title: Professor
mesh term: Dementia
mesh term: Neurocognitive Disorders
sharing ipd: No