<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/NCT03805620</url>
  </required_header>
  <id_info>
    <org_study_id>AMS-CMU</org_study_id>
    <nct_id>NCT03805620</nct_id>
  </id_info>
  <brief_title>Effects of Combined Physical-cognitive Training on Cognitive Function in MCI</brief_title>
  <official_title>Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiang Mai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiang Mai 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>
      The present study aims to investigate the effects of combined physical-cognitive training on&#xD;
      cognitive function as well as peripheral BDNF level and mitochondrial function of individuals&#xD;
      with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will&#xD;
      be superior to the physical and cognitive training program alone; and 2) the degree of&#xD;
      cognitive improvement will be positively correlated with the improvement of plasma BDNF and&#xD;
      mitochondrial function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent research suggests that the benefits of combined physical-cognitive training may be&#xD;
      greater than either physical or cognitive training alone. Nevertheless, this synergistic&#xD;
      effect has been demonstrated mainly in cognitively intact older adults. Studies examining the&#xD;
      effects of combined physical-cognitive training in older adults with MCI are scarce and show&#xD;
      mixed results. Moreover, few studies have determined the effects of the combined training on&#xD;
      peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the&#xD;
      present study aims to investigate the effects of combined physical-cognitive training on&#xD;
      cognitive function as well as peripheral BDNF level and mitochondrial function of individuals&#xD;
      with MCI. The present study will provide insight into the interplay among the training&#xD;
      program, peripheral BDNF concentration, mitochondrial function, and cognitive function.&#xD;
      Importantly, the findings will have clinical implication regarding the training program that&#xD;
      is feasible and effective in improving cognitive function of older adults with MCI which&#xD;
      ultimately will have great impact on public health as this population is at high risk of&#xD;
      progression to AD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">June 28, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Alzheimer's Disease Assessment-cognitive subscale will be assessed at baseline and 3 months. The total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline Rey auditory verbal learning score at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Memory will be assessed using Rey auditory verbal learning test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline Trail Making B-A score at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Executive function will be assessed using Trail Making Test part B-A.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change from baseline brain-derived neurotrophic factor level at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline Digit Span score at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Attention will be assessed using Digit Span forward-backward test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline stepping response time at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Processing speed will be measured using stepping response time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline time to complete Timed Up and Go at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Functional ability will be assessed using time to complete Timed Up and Go (TUG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline physiological profile assessment score at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Fall risk will be assessed using the physiological profile assessment. The test consists of five sensorimotor and balance measures including visual contrast sensitivity, proprioception, quadriceps muscle strength, hand reaction time, and postural sway. The five PPA components are weighted to compute a composite z-score distribution with high scores indicating increased fall risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline mitochondrial oxygen consumption rate at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Mitochondrial function will be determined from oxygen consumption rate (OCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline mitochondrial reactive oxygen species (ROS) level at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Mitochondrial function will be determined from reactive oxygen species (ROS) level</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Phys Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>physical training group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cog Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cognitive training group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phys-Cog Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combined physical-cognitive training group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Con Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>educational control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combined physical-cognitive training</intervention_name>
    <description>combined physical-cognitive training</description>
    <arm_group_label>Phys-Cog Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical training</intervention_name>
    <description>Multi-component physical exercise</description>
    <arm_group_label>Phys Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive training</intervention_name>
    <description>cognitive training</description>
    <arm_group_label>Cog Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based&#xD;
             on the recent DSM-V (Diagnostic Statistical Manual-V) criteria&#xD;
&#xD;
          -  comprehend instructions and willing to participate&#xD;
&#xD;
          -  able to comply with the study schedule and procedures&#xD;
&#xD;
          -  not taking any medications for their cognition and not planning to start medications&#xD;
             during the study trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of medical conditions that would be unsafe to exercise&#xD;
&#xD;
          -  diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke,&#xD;
             Multiple Sclerosis, AD) that affect cognition and mobility&#xD;
&#xD;
          -  presence of depressive symptoms&#xD;
&#xD;
          -  presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis,&#xD;
             Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)&#xD;
&#xD;
          -  exercise regularly (at least 30 min/day, 3 days/week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Somporn Sungkarat, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chiang Mai University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Associated Medical Sciences, Chiang Mai University</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiang Mai University</investigator_affiliation>
    <investigator_full_name>Somporn Sungkarat</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>mild cognitive impairment</keyword>
  <keyword>combined physical-cognitive training</keyword>
  <keyword>BDNF</keyword>
  <keyword>mitochondrial function</keyword>
  <keyword>cognitive function</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/NCT03805620
org study id: AMS-CMU
nct id: NCT03805620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study aims to investigate the effects of combined physical-cognitive training on
      cognitive function as well as peripheral BDNF level and mitochondrial function of individuals
      with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will
      be superior to the physical and cognitive training program alone; and 2) the degree of
      cognitive improvement will be positively correlated with the improvement of plasma BDNF and
      mitochondrial function.
Recent research suggests that the benefits of combined physical-cognitive training may be
      greater than either physical or cognitive training alone. Nevertheless, this synergistic
      effect has been demonstrated mainly in cognitively intact older adults. Studies examining the
      effects of combined physical-cognitive training in older adults with MCI are scarce and show
      mixed results. Moreover, few studies have determined the effects of the combined training on
      peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the
      present study aims to investigate the effects of combined physical-cognitive training on
      cognitive function as well as peripheral BDNF level and mitochondrial function of individuals
      with MCI. The present study will provide insight into the interplay among the training
      program, peripheral BDNF concentration, mitochondrial function, and cognitive function.
      Importantly, the findings will have clinical implication regarding the training program that
      is feasible and effective in improving cognitive function of older adults with MCI which
      ultimately will have great impact on public health as this population is at high risk of
      progression to AD.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
time frame: 3 months
description: Alzheimer's Disease Assessment-cognitive subscale will be assessed at baseline and 3 months. The total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
measure: change from baseline Rey auditory verbal learning score at 3 months
time frame: 3 months
description: Memory will be assessed using Rey auditory verbal learning test.
measure: change from baseline Trail Making B-A score at 3 months
time frame: 3 months
description: Executive function will be assessed using Trail Making Test part B-A.
measure: change from baseline brain-derived neurotrophic factor level at 3 months
time frame: 3 months
description: Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.
measure: change from baseline Digit Span score at 3 months
time frame: 3 months
description: Attention will be assessed using Digit Span forward-backward test.
measure: change from baseline stepping response time at 3 months
time frame: 3 months
description: Processing speed will be measured using stepping response time.
measure: change from baseline time to complete Timed Up and Go at 3 months
time frame: 3 months
description: Functional ability will be assessed using time to complete Timed Up and Go (TUG).
measure: change from baseline physiological profile assessment score at 3 months
time frame: 3 months
description: Fall risk will be assessed using the physiological profile assessment. The test consists of five sensorimotor and balance measures including visual contrast sensitivity, proprioception, quadriceps muscle strength, hand reaction time, and postural sway. The five PPA components are weighted to compute a composite z-score distribution with high scores indicating increased fall risk.
measure: change from baseline mitochondrial oxygen consumption rate at 3 months
time frame: 3 months
description: Mitochondrial function will be determined from oxygen consumption rate (OCR)
measure: change from baseline mitochondrial reactive oxygen species (ROS) level at 3 months
time frame: 3 months
description: Mitochondrial function will be determined from reactive oxygen species (ROS) level
arm group label: Phys Group
arm group type: Active Comparator
description: physical training group
arm group label: Cog Group
arm group type: Active Comparator
description: cognitive training group
arm group label: Phys-Cog Group
arm group type: Experimental
description: combined physical-cognitive training group
arm group label: Con Group
arm group type: No Intervention
description: educational control group
intervention type: Other
intervention name: Combined physical-cognitive training
description: combined physical-cognitive training
arm group label: Phys-Cog Group
intervention type: Other
intervention name: Physical training
description: Multi-component physical exercise
arm group label: Phys Group
intervention type: Other
intervention name: Cognitive training
description: cognitive training
arm group label: Cog Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
last name: Somporn Sungkarat, PhD
role: Principal Investigator
affiliation: Chiang Mai University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chiang Mai University
investigator full name: Somporn Sungkarat
investigator title: Associate Professor
mesh term: Cognitive Dysfunction
sharing ipd: No