xml: <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/NCT05983913</url>
    </required_header>
    <id_info>
      <org_study_id>SYU 2023-06-020-001</org_study_id>
      <nct_id>NCT05983913</nct_id>
    </id_info>
    <brief_title>Effects of Wearable Sensor-based Interactive Cognitive-motor Training in Older Adults.</brief_title>
    <official_title>Effects of Cognitive-motor Training Using a Wearable Sensor-based Interactive System on Cognitive and Motor Performance in Older Adults.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sahmyook University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sahmyook University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        -  Based on research showing that cognitive-motor training programs help improve cognition&#xD;
             in older adults with mild cognitive impairment, this program uses an interactive system&#xD;
             to combine cognitive training with exercise.&#xD;
  &#xD;
          -  The interactive system consists of wearable sensors and has the advantage of cognitive&#xD;
             training without space constraints, and the cognitive training program consists of a&#xD;
             total of five developed cognitive training games.&#xD;
  &#xD;
          -  The program is expected to improve the cognitive abilities of the elderly and improve&#xD;
             their physical abilities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed study will conduct a randomized controlled trial to compare the effects of a&#xD;
        cognitive-motor training program using a wearable sensor-based interactive system on the&#xD;
        cognitive and physical abilities of older adults in the community. Study participants will be&#xD;
        randomly assigned to receive one of two interventions: (a) motor-cognitive training (b)&#xD;
        cognitive training. All interventions will last 50 minutes and will be delivered twice a week&#xD;
        for 6 weeks. To determine the effectiveness of the interventions, the primary outcome will&#xD;
        assess PFC activity and cognition, and the secondary outcome will assess aerobic capacity,&#xD;
        balance, upper extremity muscle strength, lower extremity muscle strength, and instrumental&#xD;
        activities of daily living tasks. All assessments will be administered one week before and&#xD;
        one week after the intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 26, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 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>Prospective, parallel-group randomized study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in prefrontal cortex activation</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>Activation of the prefrontal cortex will be assessed by changes in HbO, and differences in PFC activity will be identified during cognitive tasks (memory, attention, and visuospatial cognition) before and after the assessment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cognition</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>For cognitive assessment, we will use the Montreal Cognitive Assessment (MoCA). The MoCA is a cognitive assessment tool used to identify MCI that assesses multiple cognitive domains, including memory, attention, language, visuospatial skills, executive function, and orientation to time and place.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Aerobic capacity</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>Aerobic capacity is measured using the 6-minute walk test (6MWT). The 6MWT measures the distance a subject can walk in six minutes. You can take as many breaks as you like and the examiner can provide a chair. The examiner records the distance you walk in six minutes, the number of breaks you take, and the duration of the breaks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in dynamic balance function 1</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>The Four Square Step Test (FSST) is used to assess dynamic balance ability. The FSST consists of stepping safely and as quickly as possible, without touching the sticks, over four sticks placed in a criss-cross configuration on the floor, and is scored by recording the time in seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in dynamic balance function 2</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>Dynamic balance is assessed using the Functional Reach Test (FRT). The FRT measures the distance (in centimeters) that the head of the third metacarpal of the hand moves by extending the arm forward without moving the foot from a standing position.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in static balance function</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>To assess static balance, using the Single Leg Stance Test (SLS). The SLS measures the number of seconds standing on one leg with hands on hips and eyes open.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in upper extremity strengthen</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>Upper extremity strength is assessed with the arm curl test. On women perform a biceps curl with a 2.3 kg dumbbell and men with a 3.6 kg dumbbell. They are seated in a chair with no armrests or backrest. Scoring is based on the number of repetitions performed in 30 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in grip strengthen</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>Grip strength is measured using a dynamometer and the subject is seated in a chair with arms extended, natural rotation, elbow flexed 90 degrees, forearm at natural angle and wrist in dorsiflexion between 0 and 30 degrees. The subject is then asked to grip the dynamometer for 3 seconds and the average value (kg) over 3 trials is recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in lower extremity strengthen</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>Lower extremity strength is assessed using the 5 sit to stand test (5xSST). The 5xSST measures the number of seconds a subject can go from sitting to standing and back to sitting five times, with the shorter the time, the better the strength.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Instrumental Activity of Daily Living(IADLs)</measure>
      <time_frame>change from baseline to 6 week post intervention</time_frame>
      <description>IADLs require higher cognitive skills than basic activities of daily living, and IADLs can detect functional changes in the early stages of dementia. Instrumental IADLs are assessed using the Functional Activities Questionnaire (FAQ). The FAQ can differentiate between Mild cognitive impairment(MCI) and mild Alzheimer's disease(AD).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cognitive Decline, Mild</condition>
    <condition>Cognition Disorders in Old Age</condition>
    <condition>Subjective Memory Decline</condition>
    <arm_group>
      <arm_group_label>cognitive-motor training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 50 minutes of cognitive-motor training twice per week for 6 weeks. The cognitive-motor training program uses a wearable sensor-based interactive system to perform cognitive tasks in a large space without the constraints of physical movement. Participants wear a wearable sensor-based device on their dominant arm or leg and use an interactive system to perform cognitive-motor tasks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cognition training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 50 minutes of cognitive training twice a week for 6 weeks. The cognitive training program will be delivered in booklet form, and participants will perform the cognitive tasks of the cognitive-motor training in a seated position with no physical movement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>cognitive-motor training</intervention_name>
      <description>The cognitive-motor training program consists of five cognitive tasks related to concentration, reaction time, and executive function, combined with physical exercises using an interactive system. The five tasks include: (1) number sequence, (2) number-word sequence, (3) card matching games, (4) memorizing numbers, and (5) route-finding games.</description>
      <arm_group_label>cognitive-motor training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>cognition training</intervention_name>
      <description>The intervention consists of five cognitive tasks (memory, attention, spatial and temporal perception) with difficulty levels adapted to the individual's cognitive abilities.</description>
      <arm_group_label>cognition training group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Community-dwelling seniors age 65 and older&#xD;
  &#xD;
            -  MMSE-K 18 or less&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People of Hospitalized or institutionalized&#xD;
  &#xD;
            -  People diagnosed with Alzheimer's disease&#xD;
  &#xD;
            -  People diagnosed with vascular dementia&#xD;
  &#xD;
            -  People with musculoskeletal conditions that make physical activity difficult&#xD;
  &#xD;
            -  People with dizziness that makes physical activity difficult&#xD;
  &#xD;
            -  People with a wound or bleeding in the head&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Seungwon Lee, Ph.D</last_name>
      <phone>+82233991630</phone>
      <email>swlee@syu.ac.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jihye Jung, MS</last_name>
      <phone>+821089113752</phone>
      <email>jihye3752@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mapo senior welfare center</name>
        <address>
          <city>Seoul</city>
          <zip>04099</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Seungwon Lee, Ph.D</last_name>
        <phone>+8233991630</phone>
        <email>swlee@syu.ac.kr</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sahmyook University</investigator_affiliation>
      <investigator_full_name>Jihye Jung</investigator_full_name>
      <investigator_title>Physical Therapist</investigator_title>
    </responsible_party>
    <keyword>cognitive-motor training</keyword>
    <keyword>cogntion</keyword>
    <keyword>physical function</keyword>
    <keyword>older adults</keyword>
    <keyword>interactive system</keyword>
    <keyword>wearable sensor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Cognition Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983913
  org study id: SYU 2023-06-020-001
  nct id: NCT05983913
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  -  Based on research showing that cognitive-motor training programs help improve cognition
             in older adults with mild cognitive impairment, this program uses an interactive system
             to combine cognitive training with exercise.
  
          -  The interactive system consists of wearable sensors and has the advantage of cognitive
             training without space constraints, and the cognitive training program consists of a
             total of five developed cognitive training games.
  
          -  The program is expected to improve the cognitive abilities of the elderly and improve
             their physical abilities.
  The proposed study will conduct a randomized controlled trial to compare the effects of a
        cognitive-motor training program using a wearable sensor-based interactive system on the
        cognitive and physical abilities of older adults in the community. Study participants will be
        randomly assigned to receive one of two interventions: (a) motor-cognitive training (b)
        cognitive training. All interventions will last 50 minutes and will be delivered twice a week
        for 6 weeks. To determine the effectiveness of the interventions, the primary outcome will
        assess PFC activity and cognition, and the secondary outcome will assess aerobic capacity,
        balance, upper extremity muscle strength, lower extremity muscle strength, and instrumental
        activities of daily living tasks. All assessments will be administered one week before and
        one week after the intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, parallel-group randomized study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in prefrontal cortex activation
  time frame: change from baseline to 6 week post intervention
  description: Activation of the prefrontal cortex will be assessed by changes in HbO, and differences in PFC activity will be identified during cognitive tasks (memory, attention, and visuospatial cognition) before and after the assessment.
  measure: Change in cognition
  time frame: change from baseline to 6 week post intervention
  description: For cognitive assessment, we will use the Montreal Cognitive Assessment (MoCA). The MoCA is a cognitive assessment tool used to identify MCI that assesses multiple cognitive domains, including memory, attention, language, visuospatial skills, executive function, and orientation to time and place.
  measure: Change in Aerobic capacity
  time frame: change from baseline to 6 week post intervention
  description: Aerobic capacity is measured using the 6-minute walk test (6MWT). The 6MWT measures the distance a subject can walk in six minutes. You can take as many breaks as you like and the examiner can provide a chair. The examiner records the distance you walk in six minutes, the number of breaks you take, and the duration of the breaks.
  measure: Change in dynamic balance function 1
  time frame: change from baseline to 6 week post intervention
  description: The Four Square Step Test (FSST) is used to assess dynamic balance ability. The FSST consists of stepping safely and as quickly as possible, without touching the sticks, over four sticks placed in a criss-cross configuration on the floor, and is scored by recording the time in seconds.
  measure: Change in dynamic balance function 2
  time frame: change from baseline to 6 week post intervention
  description: Dynamic balance is assessed using the Functional Reach Test (FRT). The FRT measures the distance (in centimeters) that the head of the third metacarpal of the hand moves by extending the arm forward without moving the foot from a standing position.
  measure: Change in static balance function
  time frame: change from baseline to 6 week post intervention
  description: To assess static balance, using the Single Leg Stance Test (SLS). The SLS measures the number of seconds standing on one leg with hands on hips and eyes open.
  measure: Change in upper extremity strengthen
  time frame: change from baseline to 6 week post intervention
  description: Upper extremity strength is assessed with the arm curl test. On women perform a biceps curl with a 2.3 kg dumbbell and men with a 3.6 kg dumbbell. They are seated in a chair with no armrests or backrest. Scoring is based on the number of repetitions performed in 30 seconds.
  measure: Change in grip strengthen
  time frame: change from baseline to 6 week post intervention
  description: Grip strength is measured using a dynamometer and the subject is seated in a chair with arms extended, natural rotation, elbow flexed 90 degrees, forearm at natural angle and wrist in dorsiflexion between 0 and 30 degrees. The subject is then asked to grip the dynamometer for 3 seconds and the average value (kg) over 3 trials is recorded.
  measure: Change in lower extremity strengthen
  time frame: change from baseline to 6 week post intervention
  description: Lower extremity strength is assessed using the 5 sit to stand test (5xSST). The 5xSST measures the number of seconds a subject can go from sitting to standing and back to sitting five times, with the shorter the time, the better the strength.
  measure: Change in Instrumental Activity of Daily Living(IADLs)
  time frame: change from baseline to 6 week post intervention
  description: IADLs require higher cognitive skills than basic activities of daily living, and IADLs can detect functional changes in the early stages of dementia. Instrumental IADLs are assessed using the Functional Activities Questionnaire (FAQ). The FAQ can differentiate between Mild cognitive impairment(MCI) and mild Alzheimer's disease(AD).
  arm group label: cognitive-motor training group
  arm group type: Experimental
  description: Participants will receive 50 minutes of cognitive-motor training twice per week for 6 weeks. The cognitive-motor training program uses a wearable sensor-based interactive system to perform cognitive tasks in a large space without the constraints of physical movement. Participants wear a wearable sensor-based device on their dominant arm or leg and use an interactive system to perform cognitive-motor tasks.
  arm group label: cognition training group
  arm group type: Experimental
  description: Participants will receive 50 minutes of cognitive training twice a week for 6 weeks. The cognitive training program will be delivered in booklet form, and participants will perform the cognitive tasks of the cognitive-motor training in a seated position with no physical movement.
  intervention type: Behavioral
  intervention name: cognitive-motor training
  description: The cognitive-motor training program consists of five cognitive tasks related to concentration, reaction time, and executive function, combined with physical exercises using an interactive system. The five tasks include: (1) number sequence, (2) number-word sequence, (3) card matching games, (4) memorizing numbers, and (5) route-finding games.
  arm group label: cognitive-motor training group
  intervention type: Behavioral
  intervention name: cognition training
  description: The intervention consists of five cognitive tasks (memory, attention, spatial and temporal perception) with difficulty levels adapted to the individual's cognitive abilities.
  arm group label: cognition training group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Seungwon Lee, Ph.D
  phone: +82233991630
  email: swlee@syu.ac.kr
  last name: Jihye Jung, MS
  phone: +821089113752
  email: jihye3752@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Sahmyook University
  investigator full name: Jihye Jung
  investigator title: Physical Therapist
  mesh term: Cognitive Dysfunction
  mesh term: Cognition Disorders
  sharing ipd: No