<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/NCT03839563</url>
  </required_header>
  <id_info>
    <org_study_id>NHRI-EX108-10804PI</org_study_id>
    <nct_id>NCT03839563</nct_id>
  </id_info>
  <brief_title>Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults</brief_title>
  <official_title>Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The effectiveness of conventional exercise, tai chi chuan and health education/usual physical&#xD;
      activity over a 6-month intervention period in improving primary outcomes and secondary&#xD;
      outcomes in older mild cognitive impairment adults will be compared. Third, whether changes&#xD;
      in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor&#xD;
      (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E&#xD;
      (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the&#xD;
      intervention will be examined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait characteristics</measure>
    <time_frame>12 months</time_frame>
    <description>Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global cognition</measure>
    <time_frame>12 months</time_frame>
    <description>Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0~30, with lower scores indicating poorer global cognition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum levels of BDNF</measure>
    <time_frame>12 months</time_frame>
    <description>Serum BDNF concentrations will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum levels of IGF-1</measure>
    <time_frame>12 months</time_frame>
    <description>Serum IGF-1 concentrations will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum levels of VEGF</measure>
    <time_frame>12 months</time_frame>
    <description>Serum VEGF concentrations will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tinetti balance</measure>
    <time_frame>12 months</time_frame>
    <description>The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>12 months</time_frame>
    <description>The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>12 months</time_frame>
    <description>Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>12 months</time_frame>
    <description>number of falls and multiple falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>12 months</time_frame>
    <description>Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>12 months</time_frame>
    <description>Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">189</enrollment>
  <condition>Fallers</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Conventional exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tai chi chuan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 8-form Yang-style tai chi chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and each session will last 60 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health education/usual physical activity</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.</description>
    <arm_group_label>Conventional exercise</arm_group_label>
    <arm_group_label>Tai chi chuan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 65 years old&#xD;
&#xD;
          -  Had an emergency department visit due to a fall at least 3 months prior to the&#xD;
             baseline assessment (assuming a full recovery time from a fall to be 3 months)&#xD;
&#xD;
          -  Can ambulate independently&#xD;
&#xD;
          -  Has mild cognitive impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not live in a community setting&#xD;
&#xD;
          -  Cannot ambulate independently and communicate with researchers&#xD;
&#xD;
          -  Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of&#xD;
             breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea,&#xD;
             palpitations, or tachycardia)&#xD;
&#xD;
          -  Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe&#xD;
             pulmonary hypertension)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mau-Roung Lin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mau-Roung Lin, Professor</last_name>
    <phone>886-2-27361661</phone>
    <phone_ext>6572</phone_ext>
    <email>mrlin@tmu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Medical University</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chih-Yi Chen, Master</last_name>
      <phone>886-2-27361661</phone>
      <phone_ext>6572</phone_ext>
      <email>m513090003@tmu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biomarker</keyword>
  <keyword>Cognitive impairment</keyword>
  <keyword>Gait abnormality</keyword>
  <keyword>Older Adults</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03839563
org study id: NHRI-EX108-10804PI
nct id: NCT03839563
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The effectiveness of conventional exercise, tai chi chuan and health education/usual physical
      activity over a 6-month intervention period in improving primary outcomes and secondary
      outcomes in older mild cognitive impairment adults will be compared. Third, whether changes
      in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor
      (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E
      (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the
      intervention will be examined.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.
primary purpose: Prevention
masking: Single (Participant)
measure: Gait characteristics
time frame: 12 months
description: Performance on six gait characteristics (velocity, cadence, stride length, swing time, stride length variability, and swing time variability) will be measured with a 6-m electronic walkway of GAITRite.
measure: Global cognition
time frame: 12 months
description: Global cognition will be assessed using the Mini-Mental State Examination (MMSE). The MMSE comprises 11 questions, and the score ranges 0~30, with lower scores indicating poorer global cognition.
measure: Serum levels of BDNF
time frame: 12 months
description: Serum BDNF concentrations will be assessed.
measure: Serum levels of IGF-1
time frame: 12 months
description: Serum IGF-1 concentrations will be assessed.
measure: Serum levels of VEGF
time frame: 12 months
description: Serum VEGF concentrations will be assessed.
measure: Tinetti balance
time frame: 12 months
description: The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
measure: Mobility
time frame: 12 months
description: The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
measure: Muscle strength
time frame: 12 months
description: Grip strength will be assessed via a handgrip dynamometer and measured in kilograms of isometric force.
measure: Falls
time frame: 12 months
description: number of falls and multiple falls
measure: Depressive symptoms
time frame: 12 months
description: Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS).
measure: Fear of falling
time frame: 12 months
description: Fear of falling will be assessed using the Falls Efficacy Scale (FES) test.
arm group label: Conventional exercise
arm group type: Experimental
description: This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min.
arm group label: Tai chi chuan
arm group type: Experimental
description: The 8-form Yang-style tai chi chuan intervention will take place at a subject's residence or in the neighborhood once a week for 6 months, and each session will last 60 min.
arm group label: Health education/usual physical activity
arm group type: No Intervention
description: After the baseline, the case manager will visit subjects in this group once for comparability with the other two intervention groups and instruct them to maintain their usual physical activity.
intervention type: Behavioral
intervention name: Exercise
description: Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
arm group label: Conventional exercise
arm group label: Tai chi chuan
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mau-Roung Lin, Professor
role: Principal Investigator
affiliation: Taipei Medical University
last name: Mau-Roung Lin, Professor
phone: 886-2-27361661
phone ext: 6572
email: mrlin@tmu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No