<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/NCT02222584</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0364</org_study_id>
    <nct_id>NCT02222584</nct_id>
  </id_info>
  <brief_title>The Effects of Physical Activity on Patients With Inflammatory Bowel Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical activity (PA) is beneficial in the prevention and management of chronic disease.&#xD;
      However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and&#xD;
      whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the&#xD;
      level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the&#xD;
      effect of PA on quality of life of patients with IBD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>level of physical activity (PA)</measure>
    <time_frame>1 hour</time_frame>
    <description>Physical activity (PA) levels were assessed using the International PA Questionnaire. Based on self-reported frequency (day) and duration (hr) of physical activities, corresponding metabolic equivalent (MET-hr/wk) values were calculated to lowest PA, low PA, moderate PA and highest PA</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">158</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>IBD group</arm_group_label>
    <description>patients with with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to February 2015</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with inflammatory bowel disease who are visiting the out-patient clinic of&#xD;
        severance hospital from July 2014 to Feburary 2015&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 19&#xD;
&#xD;
          -  patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis,&#xD;
             intestinal behcet's disease)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;19&#xD;
&#xD;
          -  Patient who denied to response the survey questions&#xD;
&#xD;
          -  Patient who denied to enroll the survey research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inflammatory bowel disease</keyword>
  <keyword>physical activity</keyword>
  <keyword>disease activity</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02222584
org study id: 4-2014-0364
nct id: NCT02222584
lead sponsor: 
has dmc: No
Physical activity (PA) is beneficial in the prevention and management of chronic disease.
      However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and
      whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the
      level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the
      effect of PA on quality of life of patients with IBD.
observational model: Case-Only
time perspective: Prospective
measure: level of physical activity (PA)
time frame: 1 hour
description: Physical activity (PA) levels were assessed using the International PA Questionnaire. Based on self-reported frequency (day) and duration (hr) of physical activities, corresponding metabolic equivalent (MET-hr/wk) values were calculated to lowest PA, low PA, moderate PA and highest PA
arm group label: IBD group
description: patients with with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to February 2015
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases