<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/NCT02241850</url>
  </required_header>
  <id_info>
    <org_study_id>DW-HIT01</org_study_id>
    <nct_id>NCT02241850</nct_id>
  </id_info>
  <brief_title>Genetic Polymorphisms Affecting Effect of High Intensity Training</brief_title>
  <official_title>Assessment of Genetic Polymorphisms Affecting Effect of High Intensity Training in Korean Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to investigate the effect of high intensity training on maximal&#xD;
      oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of maximal oxygen uptake</measure>
    <time_frame>Baseline and after 6, 9 weeks of training</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>High intensity training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>9 weeks of supervised training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity training</intervention_name>
    <description>9 weeks of supervised high intensity training</description>
    <arm_group_label>High intensity training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 30 to 60, healthy male subjects (at screening)&#xD;
&#xD;
          -  Volunteer who totally understands the progress of this clinical trials, make decision&#xD;
             by his free will, and signed a consent form to follow the progress.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteer who has past or present history of any diseases following below; liver&#xD;
             including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary,&#xD;
             endocrine, hematooncology, cardiology, mental disorder&#xD;
&#xD;
          -  Subject who already participated in other trials in 30 days&#xD;
&#xD;
          -  Subject who had whole blood donation in 2 months, or component blood donation in 1&#xD;
             months or transfusion&#xD;
&#xD;
          -  Subject who smokes an average of 20 cigarettes/day or drink &gt; 5 cups of coffee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sung-Vin Yim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyung Hee University Hospital</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 14, 2014</last_update_submitted>
  <last_update_submitted_qc>September 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Sung-Vin Yim</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>High Intensity Training</keyword>
  <keyword>Genetic Polymorphisms</keyword>
  <keyword>Genome Wide association study</keyword>
  <keyword>Single Nucleotide Polymorphism genotype</keyword>
  <keyword>Subjects</keyword>
  <!-- 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/NCT02241850
org study id: DW-HIT01
nct id: NCT02241850
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of the study is to investigate the effect of high intensity training on maximal
      oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change of maximal oxygen uptake
time frame: Baseline and after 6, 9 weeks of training
arm group label: High intensity training
arm group type: Other
description: 9 weeks of supervised training
intervention type: Other
intervention name: High intensity training
description: 9 weeks of supervised high intensity training
arm group label: High intensity training
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sung-Vin Yim, MD, PhD
role: Principal Investigator
affiliation: Kyung Hee University Hospital
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Sung-Vin Yim
investigator title: M.D., Ph.D.