<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/NCT01724151</url>
  </required_header>
  <id_info>
    <org_study_id>200812152R</org_study_id>
    <nct_id>NCT01724151</nct_id>
  </id_info>
  <brief_title>Effects of Exercise Training in Patients With Mild Cognitive Impairment</brief_title>
  <official_title>Effects of Exercise Training in Patients With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposes of this study are&#xD;
&#xD;
        1. To understand the physical activities of patients with cognitive impairment in Taiwan&#xD;
           and construct the validity and reliability of the physical activity questionnaire and&#xD;
           actigram in this population.&#xD;
&#xD;
        2. To understand the relation between brain structure (brain tractography and resting state&#xD;
           functional MRI) and cognitive and physical functions of patients with cognitive&#xD;
           impairment, the capability of activity and social engagement (including quality of&#xD;
           life).&#xD;
&#xD;
        3. To understand the efficacy of exercise on the brain structure (brain tractography and&#xD;
           resting state functional MRI), cognitive and physical functions, the capability of&#xD;
           activity and social engagement (including quality of life) of the patients with&#xD;
           cognitive impairment.&#xD;
&#xD;
      The study aims to establish the data base of physical activity of patients with cognitive&#xD;
      impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on&#xD;
      physical function, physical activity and social engagements to provide an optimized design of&#xD;
      exercise program for patients with cognitive impairment in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is already evidence that exercise training can delay the progression of dementia. But&#xD;
      if the same effect could be seen in patients with cognitive impairment remains unknown. There&#xD;
      is an increasing importance of how to delay or prevent the turn over of cognitive impairment&#xD;
      patients into dementia in recent years. Thus we propose to investigate the following issues.&#xD;
&#xD;
        1. To understand the physical activities of patients with cognitive impairment in Taiwan&#xD;
           and construct the validity and reliability of the physical activity questionnaire and&#xD;
           actigram in this population.&#xD;
&#xD;
        2. To understand the relation between brain structure (brain tractography and resting state&#xD;
           functional MRI) and cognitive and physical functions of patients with cognitive&#xD;
           impairment , the capability of activity and social engagement (including quality of&#xD;
           life).&#xD;
&#xD;
        3. To understand the efficacy of exercise on the brain structure (brain tractography and&#xD;
           resting state functional MRI), cognitive and physical functions, the capability of&#xD;
           activity and social engagement (including quality of life) of patients with cognitive&#xD;
           impairment.&#xD;
&#xD;
      The study is a cross sectional study. We recruited 40 cognitive impairment patients from the&#xD;
      memory clinic at National Taiwan University Hospital and another 20 healthy controls matched&#xD;
      for age and gender. We collected the actigram and physical activity from questionnaire for 7&#xD;
      days and performed the analysis for reliability and validity. We will do correlation analysis&#xD;
      with the data with resting state functional MRI and tractography, brain connectivity, and&#xD;
      plasma Aβ1-40 and Aβ1-42 amyloid protein.&#xD;
&#xD;
      The study aims to establish the data base of physical activity of patients with cognitive&#xD;
      impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on&#xD;
      physical function, physical activity and social engagements to provide an optimized design of&#xD;
      exercise program for patients with cognitive impairment in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">October 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Walking speed of participants</measure>
    <time_frame>1 hour</time_frame>
    <description>Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Healthy adults</arm_group_label>
    <description>Healthy adults, over 45 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild cognitive impairment</arm_group_label>
    <description>subjects with mild cognitive impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <description>subjects with Alzheimer's disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic,community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Above 45 years old and had independent walking ability&#xD;
&#xD;
          2. The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of&#xD;
             0.5 but normal ADL/IADL, and not demented&#xD;
&#xD;
          3. Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable AD&#xD;
             (McKhann, et al., 1984)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder&#xD;
             which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson&#xD;
             disease, or arthritis were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Jang Chiu</last_name>
    <role>Study Chair</role>
    <affiliation>Neurology department, National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>February 25, 2010</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>April 21, 2014</last_update_submitted>
  <last_update_submitted_qc>April 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 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>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT01724151
org study id: 200812152R
nct id: NCT01724151
lead sponsor: 
has dmc: Yes
The proposes of this study are

        1. To understand the physical activities of patients with cognitive impairment in Taiwan
           and construct the validity and reliability of the physical activity questionnaire and
           actigram in this population.

        2. To understand the relation between brain structure (brain tractography and resting state
           functional MRI) and cognitive and physical functions of patients with cognitive
           impairment, the capability of activity and social engagement (including quality of
           life).

        3. To understand the efficacy of exercise on the brain structure (brain tractography and
           resting state functional MRI), cognitive and physical functions, the capability of
           activity and social engagement (including quality of life) of the patients with
           cognitive impairment.

      The study aims to establish the data base of physical activity of patients with cognitive
      impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on
      physical function, physical activity and social engagements to provide an optimized design of
      exercise program for patients with cognitive impairment in the future.
There is already evidence that exercise training can delay the progression of dementia. But
      if the same effect could be seen in patients with cognitive impairment remains unknown. There
      is an increasing importance of how to delay or prevent the turn over of cognitive impairment
      patients into dementia in recent years. Thus we propose to investigate the following issues.

        1. To understand the physical activities of patients with cognitive impairment in Taiwan
           and construct the validity and reliability of the physical activity questionnaire and
           actigram in this population.

        2. To understand the relation between brain structure (brain tractography and resting state
           functional MRI) and cognitive and physical functions of patients with cognitive
           impairment , the capability of activity and social engagement (including quality of
           life).

        3. To understand the efficacy of exercise on the brain structure (brain tractography and
           resting state functional MRI), cognitive and physical functions, the capability of
           activity and social engagement (including quality of life) of patients with cognitive
           impairment.

      The study is a cross sectional study. We recruited 40 cognitive impairment patients from the
      memory clinic at National Taiwan University Hospital and another 20 healthy controls matched
      for age and gender. We collected the actigram and physical activity from questionnaire for 7
      days and performed the analysis for reliability and validity. We will do correlation analysis
      with the data with resting state functional MRI and tractography, brain connectivity, and
      plasma Aβ1-40 and Aβ1-42 amyloid protein.

      The study aims to establish the data base of physical activity of patients with cognitive
      impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on
      physical function, physical activity and social engagements to provide an optimized design of
      exercise program for patients with cognitive impairment in the future.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Walking speed of participants
time frame: 1 hour
description: Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)
arm group label: Healthy adults
description: Healthy adults, over 45 years old
arm group label: Mild cognitive impairment
description: subjects with mild cognitive impairment
arm group label: Alzheimer's disease
description: subjects with Alzheimer's disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ming-Jang Chiu
role: Study Chair
affiliation: Neurology department, National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction