<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/NCT02262104</url>
  </required_header>
  <id_info>
    <org_study_id>REK 2012-1150</org_study_id>
    <nct_id>NCT02262104</nct_id>
  </id_info>
  <brief_title>Effects of an Exercise Program for Nursing Home Patients With Dementia</brief_title>
  <acronym>EXDEM</acronym>
  <official_title>Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Centre for Ageing and Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of an exercise program on nursing home&#xD;
      patients with dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention group will be exercising one hour twice a week for 12 weeks. The&#xD;
      participants will be doing intensive strength exercises and challenging balance exercises in&#xD;
      groups of 4-6. Two physical therapists will be leading the intervention group. The control&#xD;
      group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational&#xD;
      therapist. The participants will be doing relaxation exercises, listen to music and social&#xD;
      activities such as board games or indoor bowling.&#xD;
&#xD;
      The investigators will carry out three test periods:&#xD;
&#xD;
        -  Baseline testing before intervention start&#xD;
&#xD;
        -  Post test after 12 weeks of intervention&#xD;
&#xD;
        -  Follow-up 12 weeks after post test.&#xD;
&#xD;
      The testing will comprise:&#xD;
&#xD;
        -  Physical tests carried out by physiotherapists&#xD;
&#xD;
        -  Questionnaires concerning mental health and ADL (activities of daily living)&#xD;
&#xD;
        -  Cognition tests&#xD;
&#xD;
        -  Cortisol in saliva&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intensive exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive exercise</intervention_name>
    <description>Arm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist</description>
    <arm_group_label>Intensive exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;55 years old&#xD;
&#xD;
          -  Living in nursing home&#xD;
&#xD;
          -  Able to stand with help from max 1&#xD;
&#xD;
          -  Able to walk 6 meters with or without walking aid&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  Longterm psychotic&#xD;
&#xD;
          -  Severe communication problems&#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>Astrid Bergland</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo and Akershus University college of Applied science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo and Akershus University College of Applied Sciences</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 23, 2013</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo Metropolitan University</investigator_affiliation>
    <investigator_full_name>Elisabeth Wiken Telenius</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>dementia</keyword>
  <keyword>nursing home</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT02262104
org study id: REK 2012-1150
nct id: NCT02262104
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the effect of an exercise program on nursing home
      patients with dementia.
The intervention group will be exercising one hour twice a week for 12 weeks. The
      participants will be doing intensive strength exercises and challenging balance exercises in
      groups of 4-6. Two physical therapists will be leading the intervention group. The control
      group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational
      therapist. The participants will be doing relaxation exercises, listen to music and social
      activities such as board games or indoor bowling.

      The investigators will carry out three test periods:

        -  Baseline testing before intervention start

        -  Post test after 12 weeks of intervention

        -  Follow-up 12 weeks after post test.

      The testing will comprise:

        -  Physical tests carried out by physiotherapists

        -  Questionnaires concerning mental health and ADL (activities of daily living)

        -  Cognition tests

        -  Cortisol in saliva
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Berg Balance Scale
time frame: 12 weeks
arm group label: Intensive exercise
arm group type: Experimental
description: Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists.
arm group label: Control
arm group type: Placebo Comparator
description: Control group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff
intervention type: Behavioral
intervention name: Intensive exercise
description: Arm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist
arm group label: Intensive exercise
intervention type: Behavioral
intervention name: Control
description: Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff
arm group label: Control
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Astrid Bergland
role: Principal Investigator
affiliation: Oslo and Akershus University college of Applied science
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo Metropolitan University
investigator full name: Elisabeth Wiken Telenius
investigator title: Research Fellow
mesh term: Dementia