<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/NCT03839576</url>
  </required_header>
  <id_info>
    <org_study_id>MOST106-2314-B-038-046</org_study_id>
    <nct_id>NCT03839576</nct_id>
  </id_info>
  <brief_title>Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment</brief_title>
  <official_title>Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University</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>
      A single-blinded, randomized controlled trial is designed to compare the effects of social&#xD;
      interaction, computerized cognitive training, lower extremity strengthening, and tai chi&#xD;
      chuan on improving cognitive functions and gait/mobility and reducing falls among 228&#xD;
      subjects with mild cognitive impairment, in which the influence of adherence to the&#xD;
      intervention programs will also be examined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Anticipated">January 24, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 24, 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 single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mattis Dementia Rating Scale (MDRS)</measure>
    <time_frame>12 months</time_frame>
    <description>The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0~37, 0~37, 0~6, 0~39, and 0~25 points, respectively, and a total score range of 0~144 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modified Telephone Interview of Cognitive Status (TICS-M)</measure>
    <time_frame>12 months</time_frame>
    <description>The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0~50.</description>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_outcome>
    <measure>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>
  </primary_outcome>
  <primary_outcome>
    <measure>falls</measure>
    <time_frame>12 months</time_frame>
    <description>number of falls and multiple falls</description>
  </primary_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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fear of falling</measure>
    <time_frame>12 months</time_frame>
    <description>Activities-specific Balance Confidence (ABC) scale assesses an individual's confidence in performing 16 common daily tasks without losing balance, and total scores of the ABC scale are determined by the accumulated average of each item score and range between 0 and 100, with lower scores indicating greater balance confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activity of daily living (ADL)</measure>
    <time_frame>12 months</time_frame>
    <description>The activity of daily living (ADL) scale consists of seven basic ADLs (self-feeding, self-dressing, grooming, walking, getting in/out of bed, bathing, and controlling the bladder) and seven instrumental ADLs (using a telephone, transporting oneself, shopping, preparing meals, doing housework, taking medication, and managing one's money). These items are graded as 0 points (inability), 1 point (needs some help), or 2 points (no help needed). The ADL score ranges from 0 to 28 points, with a lower score indicating greater activity disability.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">252</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Computerized cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower extremity strengthening</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.&#xD;
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 intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social interaction</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.</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>Lower extremity strengthening</arm_group_label>
    <arm_group_label>Tai chi chuan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized training</intervention_name>
    <description>Attention, memory, speed of processing, and executive functioning.</description>
    <arm_group_label>Computerized cognitive training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 65 years old&#xD;
&#xD;
          -  Had a fall at least 3 months prior to the baseline assessment&#xD;
&#xD;
          -  Can ambulate independently&#xD;
&#xD;
          -  Has mild cognitive impairment&#xD;
&#xD;
        Exclusion Criteria:&#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>No</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>January 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">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gait</keyword>
  <keyword>computerized cognitive training</keyword>
  <keyword>falls</keyword>
  <keyword>mild cognitive impairment</keyword>
  <keyword>mobility</keyword>
  <keyword>physical exercise</keyword>
  <keyword>tai chi chuan</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/NCT03839576
org study id: MOST106-2314-B-038-046
nct id: NCT03839576
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A single-blinded, randomized controlled trial is designed to compare the effects of social
      interaction, computerized cognitive training, lower extremity strengthening, and tai chi
      chuan on improving cognitive functions and gait/mobility and reducing falls among 228
      subjects with mild cognitive impairment, in which the influence of adherence to the
      intervention programs will also be examined.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls.
primary purpose: Prevention
masking: Single (Participant)
measure: Mattis Dementia Rating Scale (MDRS)
time frame: 12 months
description: The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0~37, 0~37, 0~6, 0~39, and 0~25 points, respectively, and a total score range of 0~144 points.
measure: modified Telephone Interview of Cognitive Status (TICS-M)
time frame: 12 months
description: The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0~50.
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: balance
time frame: 12 months
description: The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
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.
measure: fear of falling
time frame: 12 months
description: Activities-specific Balance Confidence (ABC) scale assesses an individual's confidence in performing 16 common daily tasks without losing balance, and total scores of the ABC scale are determined by the accumulated average of each item score and range between 0 and 100, with lower scores indicating greater balance confidence.
measure: activity of daily living (ADL)
time frame: 12 months
description: The activity of daily living (ADL) scale consists of seven basic ADLs (self-feeding, self-dressing, grooming, walking, getting in/out of bed, bathing, and controlling the bladder) and seven instrumental ADLs (using a telephone, transporting oneself, shopping, preparing meals, doing housework, taking medication, and managing one's money). These items are graded as 0 points (inability), 1 point (needs some help), or 2 points (no help needed). The ADL score ranges from 0 to 28 points, with a lower score indicating greater activity disability.
arm group label: Computerized cognitive training
arm group type: Experimental
description: The computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes.
arm group label: Lower extremity strengthening
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 intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes.
arm group label: Social interaction
arm group type: No Intervention
description: Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups.
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: Lower extremity strengthening
arm group label: Tai chi chuan
intervention type: Behavioral
intervention name: Computerized training
description: Attention, memory, speed of processing, and executive functioning.
arm group label: Computerized cognitive training
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: No
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