<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/NCT01718405</url>
  </required_header>
  <id_info>
    <org_study_id>0049</org_study_id>
    <nct_id>NCT01718405</nct_id>
  </id_info>
  <brief_title>Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that an acute bout of aerobic exercise positively effects cognition,&#xD;
      mainly executive functioning; however the effect is not observed among all people and it is&#xD;
      not clear whether only aerobic exercise can produce this effect or possibly also resistant&#xD;
      exercise. The main purpose of our study is to examine whether genetic variation is a&#xD;
      moderator of this effect and whether resistant exercise is comparable to aerobic exercise in&#xD;
      improving cognition following a single bout of exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2015</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>Basic Science</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Functioning After Exercise</measure>
    <time_frame>Five minutes</time_frame>
    <description>Computerized battery of tests evaluating cognitive functioning</description>
  </primary_outcome>
  <other_outcome>
    <measure>Genetic Variation Associated with Different Cognitive Functioning</measure>
    <time_frame>Two years</time_frame>
    <description>Genetic variation will be analyzed by extraction of genomic DNA from blood leukocytes, using a salting out procedure, and then by using polymerase chain reaction restriction fragment lengths polymorphism (PCR-RELP) methods for detection of single nucleotide polymorphism. A mutation will be discriminated by digestion with specific restriction endonucleases.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Executive Function</condition>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each individual subject will give a blood sample for genetic analysis and undertake an exercise session and a rest session as a control. Cognitive function will be tested before and after each session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive function after exercise test</intervention_name>
    <description>The individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests.</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Blood sample analysis</intervention_name>
    <description>In the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism.</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical Education Students&#xD;
&#xD;
          -  Able to sign consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Competitive athletes&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Neurologic or psychologic orders&#xD;
&#xD;
          -  Chronic diseases&#xD;
&#xD;
          -  Head Injuries&#xD;
&#xD;
          -  Hospitalization in the previous 3 months&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sharon Tsuk, PhD</last_name>
    <phone>972-522-640642</phone>
    <email>sharontsuk1@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wingate Institute</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Raffael Carasso, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sharon Tsuk, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01718405
org study id: 0049
nct id: NCT01718405
lead sponsor: 
has dmc: Yes
Studies have shown that an acute bout of aerobic exercise positively effects cognition,
      mainly executive functioning; however the effect is not observed among all people and it is
      not clear whether only aerobic exercise can produce this effect or possibly also resistant
      exercise. The main purpose of our study is to examine whether genetic variation is a
      moderator of this effect and whether resistant exercise is comparable to aerobic exercise in
      improving cognition following a single bout of exercise.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
measure: Cognitive Functioning After Exercise
time frame: Five minutes
description: Computerized battery of tests evaluating cognitive functioning
measure: Genetic Variation Associated with Different Cognitive Functioning
time frame: Two years
description: Genetic variation will be analyzed by extraction of genomic DNA from blood leukocytes, using a salting out procedure, and then by using polymerase chain reaction restriction fragment lengths polymorphism (PCR-RELP) methods for detection of single nucleotide polymorphism. A mutation will be discriminated by digestion with specific restriction endonucleases.
arm group label: Exercise Group
arm group type: Experimental
description: Each individual subject will give a blood sample for genetic analysis and undertake an exercise session and a rest session as a control. Cognitive function will be tested before and after each session.
intervention type: Other
intervention name: Cognitive function after exercise test
description: The individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests.
arm group label: Exercise Group
intervention type: Genetic
intervention name: Blood sample analysis
description: In the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism.
arm group label: Exercise Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon Tsuk, PhD
phone: 972-522-640642
email: sharontsuk1@gmail.com
facility: 
investigator: 
investigator: 
country: Israel
responsible party type: Sponsor