<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/NCT04436302</url>
  </required_header>
  <id_info>
    <org_study_id>042020</org_study_id>
    <nct_id>NCT04436302</nct_id>
  </id_info>
  <brief_title>Exergaming in People With Major Neurocognitive Disorder</brief_title>
  <official_title>The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial</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 randomized controlled trial explores the efficacy of an 8-week standing exergaming&#xD;
      program in people with major neurocognitive disorder (MNCD) residing in long-term care&#xD;
      facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial explores the efficacy of an 8-week standing exergaming&#xD;
      program in people with major neurocognitive disorder (MNCD) residing in long-term care&#xD;
      facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three&#xD;
      times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The&#xD;
      Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB),&#xD;
      Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia&#xD;
      Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are&#xD;
      measured at baseline and post intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MoCA</measure>
    <time_frame>2 years</time_frame>
    <description>Montréal Cognitive Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SPPB</measure>
    <time_frame>2 years</time_frame>
    <description>Short Physical Performance Battery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NPI</measure>
    <time_frame>2 years</time_frame>
    <description>Neuropsychiatric Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CSDD</measure>
    <time_frame>2 years</time_frame>
    <description>Cornell Scale for Depression in Dementia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DQOL</measure>
    <time_frame>2 years</time_frame>
    <description>Dementia Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>(I)ADL</measure>
    <time_frame>2 years</time_frame>
    <description>Activities of daily living</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Randomised Controlled Trial</condition>
  <condition>Major Neurocognitive Disorder</condition>
  <condition>Long-term Care Facility</condition>
  <condition>Physical Activity</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dividat senso exergame device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Listening to music</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exergame device</intervention_name>
    <description>motor-cognitive training</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Dividat senso</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria included:&#xD;
&#xD;
          -  a Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 diagnosis of MNCD&#xD;
             (American Psychiatric Association, 2013)&#xD;
&#xD;
          -  aged 65 years or older&#xD;
&#xD;
          -  a score of minimum 10 on the Mini-Mental State Examination (MMSE)&#xD;
&#xD;
          -  residing at least two weeks in the care facility at the time of inclusion&#xD;
&#xD;
          -  being physically capable of doing standing exercises (whether or not with extra&#xD;
             support).&#xD;
&#xD;
        Possible causes of MNCD were vascular dementia, Alzheimer's disease, mixed dementia,&#xD;
        Parkinson's disease or Lewy body disease.&#xD;
&#xD;
        Exclusion criteria consisted of:&#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&#xD;
&#xD;
          -  a score lower than 10 on the MMSE&#xD;
&#xD;
          -  a planned transfer to another setting within the following two months.&#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>Nathalie Swinnen</last_name>
    <phone>0032484657187</phone>
    <email>nathalie.swinnen@kuleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Davy Vancampfort</last_name>
    <phone>+32 16 37 65 64</phone>
    <email>davy.vancampfort@kuleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Long-term care facility '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>Riekje Akkerman</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</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>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</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/NCT04436302
org study id: 042020
nct id: NCT04436302
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial explores the efficacy of an 8-week standing exergaming
      program in people with major neurocognitive disorder (MNCD) residing in long-term care
      facilities.
This randomized controlled trial explores the efficacy of an 8-week standing exergaming
      program in people with major neurocognitive disorder (MNCD) residing in long-term care
      facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three
      times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The
      Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB),
      Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia
      Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are
      measured at baseline and post intervention.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: MoCA
time frame: 2 years
description: Montréal Cognitive Assessment
measure: SPPB
time frame: 2 years
description: Short Physical Performance Battery
measure: NPI
time frame: 2 years
description: Neuropsychiatric Inventory
measure: CSDD
time frame: 2 years
description: Cornell Scale for Depression in Dementia
measure: DQOL
time frame: 2 years
description: Dementia Quality of Life
measure: (I)ADL
time frame: 2 years
description: Activities of daily living
arm group label: Intervention
arm group type: Experimental
description: Dividat senso exergame device
arm group label: Control
arm group type: Active Comparator
description: Listening to music
intervention type: Device
intervention name: Exergame device
description: motor-cognitive training
arm group label: Control
arm group label: Intervention
other name: Dividat senso
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Nathalie Swinnen
phone: 0032484657187
email: nathalie.swinnen@kuleuven.be
last name: Davy Vancampfort
phone: +32 16 37 65 64
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