<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/NCT04498195</url>
  </required_header>
  <id_info>
    <org_study_id>SMUIRB#19-013</org_study_id>
    <nct_id>NCT04498195</nct_id>
  </id_info>
  <brief_title>Walking on Cognitive Function in Individuals With Mild Cognitive Impairment: A Pilot Project</brief_title>
  <official_title>Effect of a Walking Intervention on Cognitive Function in Individuals With Mild Cognitive Impairment: A Knowledge Translation to Practice Pilot Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Merritt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samuel Merritt 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>
      Background: Many studies suggest physical activity reduces risk of dementia and improves&#xD;
      global cognitive function in individuals with mild cognitive impairment (MCI). Using&#xD;
      commercial wearable technology to measure daily steps is feasible in this population.&#xD;
&#xD;
      Objectives: The purpose of this pilot study was to explore whether 12 weeks of increased&#xD;
      physical activity improved cognitive function in individuals with MCI. A wearable activity&#xD;
      tracker was used to measure participants' daily steps as a quantifiable measure of daily&#xD;
      activity level.&#xD;
&#xD;
      Design: This was a one-group pretest-posttest study.&#xD;
&#xD;
      Setting: Established memory clinic patients within a neurology department in Northern&#xD;
      California during 2019.&#xD;
&#xD;
      Participants: 17 enrolled and 14 included for data analysis. There were 7 females and 7 males&#xD;
      whose mean age was 76.21 (SD 2.69). 12 participants were White, which reflected the clinic&#xD;
      population.&#xD;
&#xD;
      Intervention: Participants were asked to wear an activity tracker for approximately 12 hours&#xD;
      a day for 12 weeks and to increase their physical activity as much as possible. They were&#xD;
      provided twice a month telephone support.&#xD;
&#xD;
      Measurements: The Montreal Cognitive Assessment (MoCA) was used to measure pretest-posttest&#xD;
      cognitive function. Timed Up and Go (TUG) was used to assess fall risk at enrollment.&#xD;
      Cumulative step count for the study period was measured with an activity tracker.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">December 6, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whether increasing the number of daily steps among older adults with mild cognitive impairment would improve their cognitive functioning.</measure>
    <time_frame>12 weeks</time_frame>
    <description>participants would wear an activity tracker and increase physical activity as much as possible within their comfort level. Participants will be tested for pretest MoCA for cognitive function and TUG for fall risk. After 12 weeks, participants will be tested for posttest MoCA to find any cognitive function change.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Cognitive Impairment, Mild</condition>
  <arm_group>
    <arm_group_label>Increase physical activity and exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>increased exercise and physical activity</intervention_name>
    <description>Participants were encouraged to increase physical activity for 12-week study duration and wear an activity tracker for a minimum of 12 hours a day.</description>
    <arm_group_label>Increase physical activity and exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants had a score of 0.5 on the Clinical Dementia Rating and are on a stable&#xD;
             medication regimen for 3 months prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of dementia; receiving chemotherapy; unstable chronic diseases; surgery&#xD;
             with general anesthesia in the prior 3 months; MRI-confirmed brain damage from trauma,&#xD;
             stroke, or other neurological disorder; a myocardial infarction &lt; 1 year; a serious or&#xD;
             non-healing wound, ulcer, or bone fracture; TUG ≥ 12 seconds; MoCA score &gt;26 or &lt;16;&#xD;
             already using a wearable activity tracker; lacked access to the internet; or&#xD;
             non-English speaking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sutter Medical Neuroscience</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samuel Merritt University</investigator_affiliation>
    <investigator_full_name>Gasong Yun Nickerson</investigator_full_name>
    <investigator_title>DNP graduate</investigator_title>
  </responsible_party>
  <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/NCT04498195
org study id: SMUIRB#19-013
nct id: NCT04498195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Many studies suggest physical activity reduces risk of dementia and improves
      global cognitive function in individuals with mild cognitive impairment (MCI). Using
      commercial wearable technology to measure daily steps is feasible in this population.

      Objectives: The purpose of this pilot study was to explore whether 12 weeks of increased
      physical activity improved cognitive function in individuals with MCI. A wearable activity
      tracker was used to measure participants' daily steps as a quantifiable measure of daily
      activity level.

      Design: This was a one-group pretest-posttest study.

      Setting: Established memory clinic patients within a neurology department in Northern
      California during 2019.

      Participants: 17 enrolled and 14 included for data analysis. There were 7 females and 7 males
      whose mean age was 76.21 (SD 2.69). 12 participants were White, which reflected the clinic
      population.

      Intervention: Participants were asked to wear an activity tracker for approximately 12 hours
      a day for 12 weeks and to increase their physical activity as much as possible. They were
      provided twice a month telephone support.

      Measurements: The Montreal Cognitive Assessment (MoCA) was used to measure pretest-posttest
      cognitive function. Timed Up and Go (TUG) was used to assess fall risk at enrollment.
      Cumulative step count for the study period was measured with an activity tracker.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Whether increasing the number of daily steps among older adults with mild cognitive impairment would improve their cognitive functioning.
time frame: 12 weeks
description: participants would wear an activity tracker and increase physical activity as much as possible within their comfort level. Participants will be tested for pretest MoCA for cognitive function and TUG for fall risk. After 12 weeks, participants will be tested for posttest MoCA to find any cognitive function change.
arm group label: Increase physical activity and exercise
arm group type: Experimental
intervention type: Behavioral
intervention name: increased exercise and physical activity
description: Participants were encouraged to increase physical activity for 12-week study duration and wear an activity tracker for a minimum of 12 hours a day.
arm group label: Increase physical activity and exercise
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Samuel Merritt University
investigator full name: Gasong Yun Nickerson
investigator title: DNP graduate
mesh term: Cognitive Dysfunction
sharing ipd: No