<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/NCT03750812</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0065-18</org_study_id>
    <nct_id>NCT03750812</nct_id>
  </id_info>
  <brief_title>The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions</brief_title>
  <official_title>The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 proposed study is intended to examine the connection between two types of inhibition -&#xD;
      cognitive and motor and the connection between motor inhibitory functions and a single bout&#xD;
      of physical exercise in the context of age and physical fitness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in cognitive functions after exercise</measure>
    <time_frame>One and a half hours</time_frame>
    <description>This improvement will be measured through use of a vocal stroop test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in motor functions after exercise</measure>
    <time_frame>One and a half hours</time_frame>
    <description>This improvement will be measured through use of a multi-limb reaction time test</description>
  </primary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Physical Activity</condition>
  <condition>Age-related Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Highly fit older adults - Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This will receive an aerobic exercise intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poorly fit older adults - Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive an aerobic exercise intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Highly fit young adults - Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive an aerobic exercise intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poorly fit young adults - Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive an aerobic exercise intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Highly fit older adults - TV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will sit at rest and watch television</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poorly fit older adults - TV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will sit at rest and watch television</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Highly fit young adults - TV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will sit at rest and watch television</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poorly fit young adults - TV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will sit at rest and watch television</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Medium-intense 60% heart rate reserve (HRR) aerobic exercise on a treadmill for 30 minutes</description>
    <arm_group_label>Highly fit older adults - Exercise</arm_group_label>
    <arm_group_label>Highly fit young adults - Exercise</arm_group_label>
    <arm_group_label>Poorly fit older adults - Exercise</arm_group_label>
    <arm_group_label>Poorly fit young adults - Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Watching television</intervention_name>
    <description>Sitting and watching television for 30 minutes</description>
    <arm_group_label>Highly fit older adults - TV</arm_group_label>
    <arm_group_label>Highly fit young adults - TV</arm_group_label>
    <arm_group_label>Poorly fit older adults - TV</arm_group_label>
    <arm_group_label>Poorly fit young adults - TV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Do not take psychiatric drugs on a regular basis&#xD;
&#xD;
          -  Geriatric Depression Scale score less than 3&#xD;
&#xD;
          -  Mini-Mental State Examination score higher than 27&#xD;
&#xD;
          -  Healthy and able to exercise at medium intensity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yael Netz, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Wingate Academic Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mona Abu-Rukun, MA</last_name>
    <phone>972-54-5343199</phone>
    <email>mona1986ar@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hille Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Eias Kassem, MD</last_name>
      <email>eiask@hy.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03750812
org study id: HYMC-0065-18
nct id: NCT03750812
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The proposed study is intended to examine the connection between two types of inhibition -
      cognitive and motor and the connection between motor inhibitory functions and a single bout
      of physical exercise in the context of age and physical fitness.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in cognitive functions after exercise
time frame: One and a half hours
description: This improvement will be measured through use of a vocal stroop test
measure: Improvement in motor functions after exercise
time frame: One and a half hours
description: This improvement will be measured through use of a multi-limb reaction time test
arm group label: Highly fit older adults - Exercise
arm group type: Active Comparator
description: This will receive an aerobic exercise intervention
arm group label: Poorly fit older adults - Exercise
arm group type: Active Comparator
description: This arm will receive an aerobic exercise intervention
arm group label: Highly fit young adults - Exercise
arm group type: Active Comparator
description: This arm will receive an aerobic exercise intervention
arm group label: Poorly fit young adults - Exercise
arm group type: Active Comparator
description: This arm will receive an aerobic exercise intervention
arm group label: Highly fit older adults - TV
arm group type: Active Comparator
description: This arm will sit at rest and watch television
arm group label: Poorly fit older adults - TV
arm group type: Active Comparator
description: This arm will sit at rest and watch television
arm group label: Highly fit young adults - TV
arm group type: Active Comparator
description: This arm will sit at rest and watch television
arm group label: Poorly fit young adults - TV
arm group type: Active Comparator
description: This arm will sit at rest and watch television
intervention type: Behavioral
intervention name: Aerobic Exercise
description: Medium-intense 60% heart rate reserve (HRR) aerobic exercise on a treadmill for 30 minutes
arm group label: Highly fit older adults - Exercise
arm group label: Highly fit young adults - Exercise
arm group label: Poorly fit older adults - Exercise
arm group label: Poorly fit young adults - Exercise
intervention type: Behavioral
intervention name: Watching television
description: Sitting and watching television for 30 minutes
arm group label: Highly fit older adults - TV
arm group label: Highly fit young adults - TV
arm group label: Poorly fit older adults - TV
arm group label: Poorly fit young adults - TV
criteria: 
gender: All
minimum age: 22 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yael Netz, PhD
role: Study Director
affiliation: Wingate Academic Institute
last name: Mona Abu-Rukun, MA
phone: 972-54-5343199
email: mona1986ar@gmail.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No