<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/NCT04463797</url>
  </required_header>
  <id_info>
    <org_study_id>YM109044F</org_study_id>
    <nct_id>NCT04463797</nct_id>
  </id_info>
  <brief_title>Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI</brief_title>
  <official_title>Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming 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>
      This is a single-blinded, randomized controlled trail with pre- and post-measurements. The&#xD;
      inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one&#xD;
      of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination&#xD;
      (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score &lt; 26, and (4) ability to walk&#xD;
      independently for 1 min without assistive devices. The exclusion criteria are: unstable&#xD;
      physical condition, any neurological, psychiatric disorder, or diagnosed with learning&#xD;
      disability which may affect participation in this study. Twenty-eight elderly will be&#xD;
      recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group&#xD;
      (n=14) or control group (n=14). The intervention for both group will be 50 minutes per&#xD;
      session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status&#xD;
      indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score.&#xD;
      Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive&#xD;
      function, physical performance, and brain activation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and purpose:&#xD;
&#xD;
      Frailty is a continuous decline of multiple physiological systems along with aging. Common&#xD;
      characteristics of frailty are fatigue, weakness, weight loss, slowness, and low physical&#xD;
      activity. Brain changes accompanying frailty may lead to cognitive decline. Moreover,&#xD;
      evidence showed positive relations between frailty and cognitive decline. Frailty with&#xD;
      cognitive decline increases the risk of various adverse outcomes, such as disability,&#xD;
      hospitalization, incidence of dementia, loss of daily activity functioning, and poor quality&#xD;
      of life. Physical exercise training is a common intervention for frail elderly; however, most&#xD;
      studies applying physical exercise to frail elderly are for enhancing physical performance,&#xD;
      few are for improving cognitive function. On the other hand, the square-stepping exercise has&#xD;
      been proven to be beneficial to healthy older adults for both physical performance and&#xD;
      cognitive function, but it's application for frail elderly is scarce. Therefore, the purpose&#xD;
      of this study is to explore the effects of the square-stepping exercise on frailty and&#xD;
      cognitive function in elderly with frailty and mild cognitive impairment (MCI).&#xD;
&#xD;
      Method:&#xD;
&#xD;
      This is a single-blinded, randomized controlled trail with pre- and post-measurements. The&#xD;
      inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one&#xD;
      of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination&#xD;
      (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score &lt; 26, and (4) ability to walk&#xD;
      independently for 1 min without assistive devices. The exclusion criteria are: unstable&#xD;
      physical condition, any neurological, psychiatric disorder, or diagnosed with learning&#xD;
      disability which may affect participation in this study. Twenty-eight elderly will be&#xD;
      recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group&#xD;
      (n=14) or control group (n=14). The intervention for both group will be 50 minutes per&#xD;
      session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status&#xD;
      indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score.&#xD;
      Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive&#xD;
      function, physical performance, and brain activation.&#xD;
&#xD;
      SPSS 25.0 will be used for data analysis, with significant level set at 0.05. Repeated&#xD;
      measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to&#xD;
      compare between time (pre-test, post-test) and between groups. Chi-square test (χ2 test) will&#xD;
      be applied comparing data of frailty/ MCI reverse rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">May 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 28, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fried frailty criteria</measure>
    <time_frame>10 minutes</time_frame>
    <description>To assess the frailty status, score ranges from 1 to 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Montreal Cognitive Assessment</measure>
    <time_frame>8 minutes</time_frame>
    <description>Evaluating global cognitive function, score ranges from 1 to 30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frailty reverse rate</measure>
    <time_frame>2 minutes</time_frame>
    <description>The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MCI reverse rate</measure>
    <time_frame>2 minutes</time_frame>
    <description>The percentage of subjects in each group who reverse from MCI to normal cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Span Test</measure>
    <time_frame>8 minutes</time_frame>
    <description>Attention and memory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test</measure>
    <time_frame>8 minutes</time_frame>
    <description>Executive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>5 minutes</time_frame>
    <description>Dynamic balance and mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walk test</measure>
    <time_frame>10 minutes</time_frame>
    <description>Endurance and physical fitness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity strength</measure>
    <time_frame>5 minutes</time_frame>
    <description>Measuring lower extremity strength of the subject with a dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain activation</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Frailty</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Square-stepping exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Square-stepping exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Whole-body stretching and upper extremity strengthening</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Square-stepping exercise</intervention_name>
    <description>The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.</description>
    <arm_group_label>Square-stepping exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stretching and strengthening</intervention_name>
    <description>whole-body stretching and upper extremity strengthening</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 65 to 90 years old&#xD;
&#xD;
          -  Presence of at least one of the 5 physical characteristics of frailty defined by Fried&#xD;
&#xD;
          -  Mini-mental state examination (MMSE) score more than or equal to 24&#xD;
&#xD;
          -  Montreal cognitive assessment (MoCA) score less than 26&#xD;
&#xD;
          -  Ability to walk independently for 1 min without assistive devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable physical condition&#xD;
&#xD;
          -  Any neurological or psychiatric disorder&#xD;
&#xD;
          -  Diagnosed with learning disability which may affect participation in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ray-Yau Wang, Professor</last_name>
    <phone>+886-2-2826-7210</phone>
    <email>rywang@nycu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Yang-Ming University</name>
      <address>
        <city>Taipei</city>
        <state>Beitou District</state>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ray-Yau Wang, Professor</last_name>
      <phone>+886-2-2826-7210</phone>
      <email>rywang@nycu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Frailty</keyword>
  <keyword>Mild cognitive impairment</keyword>
  <keyword>Square-stepping exercise</keyword>
  <keyword>Cognitive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04463797
org study id: YM109044F
nct id: NCT04463797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-blinded, randomized controlled trail with pre- and post-measurements. The
      inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one
      of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination
      (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score < 26, and (4) ability to walk
      independently for 1 min without assistive devices. The exclusion criteria are: unstable
      physical condition, any neurological, psychiatric disorder, or diagnosed with learning
      disability which may affect participation in this study. Twenty-eight elderly will be
      recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group
      (n=14) or control group (n=14). The intervention for both group will be 50 minutes per
      session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status
      indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score.
      Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive
      function, physical performance, and brain activation.
Background and purpose:

      Frailty is a continuous decline of multiple physiological systems along with aging. Common
      characteristics of frailty are fatigue, weakness, weight loss, slowness, and low physical
      activity. Brain changes accompanying frailty may lead to cognitive decline. Moreover,
      evidence showed positive relations between frailty and cognitive decline. Frailty with
      cognitive decline increases the risk of various adverse outcomes, such as disability,
      hospitalization, incidence of dementia, loss of daily activity functioning, and poor quality
      of life. Physical exercise training is a common intervention for frail elderly; however, most
      studies applying physical exercise to frail elderly are for enhancing physical performance,
      few are for improving cognitive function. On the other hand, the square-stepping exercise has
      been proven to be beneficial to healthy older adults for both physical performance and
      cognitive function, but it's application for frail elderly is scarce. Therefore, the purpose
      of this study is to explore the effects of the square-stepping exercise on frailty and
      cognitive function in elderly with frailty and mild cognitive impairment (MCI).

      Method:

      This is a single-blinded, randomized controlled trail with pre- and post-measurements. The
      inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one
      of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination
      (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score < 26, and (4) ability to walk
      independently for 1 min without assistive devices. The exclusion criteria are: unstable
      physical condition, any neurological, psychiatric disorder, or diagnosed with learning
      disability which may affect participation in this study. Twenty-eight elderly will be
      recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group
      (n=14) or control group (n=14). The intervention for both group will be 50 minutes per
      session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status
      indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score.
      Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive
      function, physical performance, and brain activation.

      SPSS 25.0 will be used for data analysis, with significant level set at 0.05. Repeated
      measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to
      compare between time (pre-test, post-test) and between groups. Chi-square test (χ2 test) will
      be applied comparing data of frailty/ MCI reverse rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fried frailty criteria
time frame: 10 minutes
description: To assess the frailty status, score ranges from 1 to 5.
measure: The Montreal Cognitive Assessment
time frame: 8 minutes
description: Evaluating global cognitive function, score ranges from 1 to 30.
measure: Frailty reverse rate
time frame: 2 minutes
description: The percentage of subjects in each group who reverse from prefrail to robust, and frail to prefrail or robust.
measure: MCI reverse rate
time frame: 2 minutes
description: The percentage of subjects in each group who reverse from MCI to normal cognitive function.
measure: Digit Span Test
time frame: 8 minutes
description: Attention and memory
measure: Trail Making Test
time frame: 8 minutes
description: Executive function
measure: Timed Up and Go Test
time frame: 5 minutes
description: Dynamic balance and mobility
measure: 6-minute walk test
time frame: 10 minutes
description: Endurance and physical fitness
measure: Lower extremity strength
time frame: 5 minutes
description: Measuring lower extremity strength of the subject with a dynamometer.
measure: Brain activation
time frame: 30 minutes
description: Measured by a wearable functional near-infrared spectroscopy system in bilateral prefrontal cortex (PFC), premotor cortex (PMC), supplementary motor area (SMA).
arm group label: Square-stepping exercise group
arm group type: Experimental
description: Square-stepping exercise
arm group label: Control group
arm group type: Active Comparator
description: Whole-body stretching and upper extremity strengthening
intervention type: Other
intervention name: Square-stepping exercise
description: The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.
arm group label: Square-stepping exercise group
intervention type: Other
intervention name: Stretching and strengthening
description: whole-body stretching and upper extremity strengthening
arm group label: Control group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ray-Yau Wang, Professor
phone: +886-2-2826-7210
email: rywang@nycu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Frailty
mesh term: Cognitive Dysfunction
sharing ipd: Undecided