<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/NCT03811314</url>
  </required_header>
  <id_info>
    <org_study_id>CF18010B</org_study_id>
    <nct_id>NCT03811314</nct_id>
  </id_info>
  <brief_title>The Therapeutic Effect of Exercise Training on Patients With Dementia</brief_title>
  <official_title>The Therapeutic Effect of Exercise Training on Old Patients With Dementia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</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 aimed to clarify whether strength training or aerobic training could bring more&#xD;
      benefits for patients with dementia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise training has been evidenced to bring various of benefits for patients with dementia&#xD;
      in past studies. However, whether strength training or aerobic training could bring better&#xD;
      benefits has not been confirmed in the past. This study designed to recruit 30 patients with&#xD;
      mild dementia in the first year. Every patient will receive strength training using&#xD;
      dumbbells, butterfly machine and vertical leg press machine for four weeks. Outcome measures&#xD;
      including self care ability, cognitive function, MCP-1, BDNF and IGF-1 levels, and the degree&#xD;
      of depression will be recorded before and after the training. In the second year, the&#xD;
      investigators also designed to recruit 31 patients with mild dementia. These participants&#xD;
      will instead receive aerobic training using stationary bicycle for four weeks. The same&#xD;
      outcome measures will be tested as in the first year. Via the results of this study, whether&#xD;
      strength training or aerobic training could bring better benefits in dementia patient can&#xD;
      thus be elucidated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2018</start_date>
  <completion_date type="Actual">December 26, 2018</completion_date>
  <primary_completion_date type="Actual">December 26, 2018</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>
    <intervention_model_description>comparison of therapeutic effect between aerobic and strength training on dementia patient</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Barthel index</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini-mental state examination</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate cognitive function, range from 0-30, higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate cognitive function, range from 0-30, higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geriatric Depression Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum brain derived neurotrophic factor (BDNF)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Increasing BDNF level is related to preventing neurodegeneration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasma insulin-like growth factor-1 (IGF-1)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Lower plasma level of IGF-1 is associated with an increased risk of developing Alzheimer's dementia, and higher levels of it may protect against neurodegeneration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The elevation of MCP-1 concentration usually means the progression of systemic inflammation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Strength training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Muscle strength training programs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic training programs</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <description>Using dumbbells, butterfly machine and vertical leg press machine for strength training, 12 repetition maximum weight for 12 repetition, three times a day, five days a week, for a total of four weeks</description>
    <arm_group_label>Strength training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aerobic training</intervention_name>
    <description>Using stationary bicycle to perform cardiopulmonary endurance training in 50-70 heart rate reserve for 20 minutes, five days per week, for a total of four weeks</description>
    <arm_group_label>Aerobic training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patients aged above 65 years old&#xD;
&#xD;
          2. Patients with mild dementia with Mini-mental state examination scoring 15 to 26&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Cardiopulmonary diseases or orthopedical conditions that prohibit the patient from&#xD;
             receiving exercise training of our programs&#xD;
&#xD;
          2. Cognitive problems that impede the patient to understand and answer the content of our&#xD;
             questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuan-Yang Cheng, MDPHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of rehabilitation of Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dementia</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/NCT03811314
org study id: CF18010B
nct id: NCT03811314
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to clarify whether strength training or aerobic training could bring more
      benefits for patients with dementia
Exercise training has been evidenced to bring various of benefits for patients with dementia
      in past studies. However, whether strength training or aerobic training could bring better
      benefits has not been confirmed in the past. This study designed to recruit 30 patients with
      mild dementia in the first year. Every patient will receive strength training using
      dumbbells, butterfly machine and vertical leg press machine for four weeks. Outcome measures
      including self care ability, cognitive function, MCP-1, BDNF and IGF-1 levels, and the degree
      of depression will be recorded before and after the training. In the second year, the
      investigators also designed to recruit 31 patients with mild dementia. These participants
      will instead receive aerobic training using stationary bicycle for four weeks. The same
      outcome measures will be tested as in the first year. Via the results of this study, whether
      strength training or aerobic training could bring better benefits in dementia patient can
      thus be elucidated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: comparison of therapeutic effect between aerobic and strength training on dementia patient
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Barthel index
time frame: 4 weeks
description: To evaluate function of activities of daily living, range from 0-100, higher values represent a better outcome
measure: Mini-mental state examination
time frame: 4 weeks
description: To evaluate cognitive function, range from 0-30, higher values represent a better outcome
measure: Montreal Cognitive Assessment
time frame: 4 weeks
description: To evaluate cognitive function, range from 0-30, higher values represent a better outcome
measure: Geriatric Depression Scale
time frame: 4 weeks
description: To evaluate patient's depression status, range from 0-15, higher values represent a worse outcome
measure: Concentration of serum brain derived neurotrophic factor (BDNF)
time frame: 4 weeks
description: Increasing BDNF level is related to preventing neurodegeneration.
measure: Concentration of plasma insulin-like growth factor-1 (IGF-1)
time frame: 4 weeks
description: Lower plasma level of IGF-1 is associated with an increased risk of developing Alzheimer's dementia, and higher levels of it may protect against neurodegeneration.
measure: Concentration of plasmamonocyte chemotactic protein-1 (MCP-1)
time frame: 4 weeks
description: The elevation of MCP-1 concentration usually means the progression of systemic inflammation.
arm group label: Strength training
arm group type: Experimental
description: Muscle strength training programs
arm group label: Aerobic training
arm group type: Experimental
description: Aerobic training programs
intervention type: Device
intervention name: Strength training
description: Using dumbbells, butterfly machine and vertical leg press machine for strength training, 12 repetition maximum weight for 12 repetition, three times a day, five days a week, for a total of four weeks
arm group label: Strength training
intervention type: Device
intervention name: Aerobic training
description: Using stationary bicycle to perform cardiopulmonary endurance training in 50-70 heart rate reserve for 20 minutes, five days per week, for a total of four weeks
arm group label: Aerobic training
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yuan-Yang Cheng, MDPHD
role: Principal Investigator
affiliation: Department of rehabilitation of Taichung Veterans General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Dementia