<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/NCT02196545</url>
  </required_header>
  <id_info>
    <org_study_id>MTDEM-001</org_study_id>
    <nct_id>NCT02196545</nct_id>
  </id_info>
  <brief_title>Physical Activity Training Program for Patients With Alzheimer's Dementia</brief_title>
  <acronym>MOTODEM</acronym>
  <official_title>An Easily Accessible Physical Activity Training Program for Patients With Alzheimer's Dementia: Effect on Clinical and Neurobiological Parameters (MOTODEM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RECK-Technik GmbH &amp; Co. KG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a home based physical activity training program&#xD;
      for patients with Alzheimer's dementia has effects on clinical and neurobiological&#xD;
      parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>activities of daily living</measure>
    <time_frame>change from baseline after 12 weeks</time_frame>
    <description>Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>behavioral symptoms of dementia</measure>
    <time_frame>change from baseline after 12 weeks and 24 weeks</time_frame>
    <description>Neuropsychiatric Inventory (NPI) total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cognition</measure>
    <time_frame>change from baseline after 12 weeks and 24 weeks</time_frame>
    <description>Mini Mental Status Examination (MMSE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>executive function and language ability</measure>
    <time_frame>change from baseline after 12 weeks and 24 weeks</time_frame>
    <description>semantic and phonemic word fluency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caregiver burden</measure>
    <time_frame>change from baseline after 12 weeks and 24 weeks</time_frame>
    <description>Neuropsychiatric inventory (NPI) total burden score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reaction time, hand-eye quickness and attention</measure>
    <time_frame>change from baseline after 12 weeks and 24 weeks</time_frame>
    <description>Ruler Drop Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activities of daily living</measure>
    <time_frame>change from baseline after 24 weeks</time_frame>
    <description>Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>hippocampal cortical thickness</measure>
    <time_frame>change from baseline after 12 weeks</time_frame>
    <description>subregional hippocampal cortical thickness based on MRI analyses</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Exercise</arm_group_label>
    <other_name>(RECK MotoMed®)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;55 years&#xD;
&#xD;
          -  German is the dominant language (necessary for neuropsychological testing)&#xD;
&#xD;
          -  minimum of 8 years formal school education&#xD;
&#xD;
          -  caregiver (e.g. spouse) living at home with participant&#xD;
&#xD;
          -  physical examination does not reveal contraindications to physical activity&#xD;
&#xD;
          -  stable dose of pharmacological dementia treatment according to German guidelines&#xD;
             (DGPPN) with acetylcholinesterase inhibitor or memantin or combination for at least 6&#xD;
             months&#xD;
&#xD;
          -  no other medication that could influence cognitive functioning (e.g. benzodiazepines,&#xD;
             sleep aids, neuroleptics)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of neurological or psychiatric disease other than AD&#xD;
&#xD;
          -  history of substance abuse disorder&#xD;
&#xD;
          -  history of electroconvulsive therapy (ECT) during the last 6 months&#xD;
&#xD;
          -  structural brain deficits diagnosed in the MRI scan, also without clinical relevance&#xD;
             (incidental finding)&#xD;
&#xD;
          -  pacemaker, artificial heart valve, insulin pump or other medical implants&#xD;
&#xD;
          -  average steps/day are above 10.000 steps/day&#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>Vjera A Holthoff, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technische Universität Dresden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Technische Universität Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</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>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</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/NCT02196545
org study id: MTDEM-001
nct id: NCT02196545
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if a home based physical activity training program
      for patients with Alzheimer's dementia has effects on clinical and neurobiological
      parameters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: activities of daily living
time frame: change from baseline after 12 weeks
description: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
measure: behavioral symptoms of dementia
time frame: change from baseline after 12 weeks and 24 weeks
description: Neuropsychiatric Inventory (NPI) total score
measure: cognition
time frame: change from baseline after 12 weeks and 24 weeks
description: Mini Mental Status Examination (MMSE)
measure: executive function and language ability
time frame: change from baseline after 12 weeks and 24 weeks
description: semantic and phonemic word fluency
measure: caregiver burden
time frame: change from baseline after 12 weeks and 24 weeks
description: Neuropsychiatric inventory (NPI) total burden score
measure: Reaction time, hand-eye quickness and attention
time frame: change from baseline after 12 weeks and 24 weeks
description: Ruler Drop Test
measure: activities of daily living
time frame: change from baseline after 24 weeks
description: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
measure: hippocampal cortical thickness
time frame: change from baseline after 12 weeks
description: subregional hippocampal cortical thickness based on MRI analyses
arm group label: Exercise
arm group type: Experimental
description: Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)
arm group label: Treatment as usual
arm group type: No Intervention
description: Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise
intervention type: Behavioral
intervention name: Exercise
arm group label: Exercise
other name: (RECK MotoMed®)
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Vjera A Holthoff, Prof.
role: Principal Investigator
affiliation: Technische Universität Dresden
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Dementia
mesh term: Alzheimer Disease