<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/NCT03754881</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0964</org_study_id>
    <nct_id>NCT03754881</nct_id>
  </id_info>
  <brief_title>Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation</brief_title>
  <official_title>Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan 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>
      In korea, it is not easy to practice standard pulmonary rehabilitation (PR). in this study,&#xD;
      we'll educate PR to patients and make reservation for re-visiting outpatients clinics with PR&#xD;
      diary. we want to confirm whether patients, who perform home based PR during more than 30&#xD;
      minutes in 3 days per week, present improved dyspnea score or quality of life compared with&#xD;
      non-compliance group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">September 6, 2020</completion_date>
  <primary_completion_date type="Actual">May 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from 6 minutes walk test at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from BODE index at 8 weeks</measure>
    <time_frame>8 weeks</time_frame>
    <description>BODE index include forced expiratory volume-one second, 6 minutes walk distance, modified Medical Research Council dyspnea scale, body mass index. The BODE Index is used to predict mortality.</description>
  </secondary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pulmonary rehabilitation</intervention_name>
    <description>In this study, we'll educate pulmonary rehabilitation to patients and make reservation for re-visiting outpatients clinics with PR diary after 8 weeks.&#xD;
we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic obsturctive pulmonary disease in Asan Medical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  forced expiratory volume-one second / forced vital capacity &lt; 0.7 in&#xD;
             post-bronchodilator pulmonary function test&#xD;
&#xD;
          -  adults 40 years or older&#xD;
&#xD;
          -  no history of acute exacerbation within 4 weeks&#xD;
&#xD;
          -  no history of education for pulmonary rehabilitation within 6 months&#xD;
&#xD;
          -  no change of medication for chronic obstructive pulmonary disease within 4 weeks&#xD;
&#xD;
          -  dyspnea more than Modified Medical Research Council grade 0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  adults under 40 years old&#xD;
&#xD;
          -  no consent&#xD;
&#xD;
          -  history of acute exacerbation within 4 weeks&#xD;
&#xD;
          -  history of education for pulmonary rehabilitation within 6 months&#xD;
&#xD;
          -  change of medication for chronic obstructive pulmonary disease within 4 weeks&#xD;
&#xD;
          -  dyspnea only Modified Medical Research Council grade 0&#xD;
&#xD;
          -  comorbidity, including cardiovascular disease, orthopedic disease, neurologic disease,&#xD;
             optic disease, uncontrolled hypertension&#xD;
&#xD;
          -  enrolled other clinical trial&#xD;
&#xD;
          -  on long term oxygen therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Sei Won Lee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03754881
org study id: 2018-0964
nct id: NCT03754881
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In korea, it is not easy to practice standard pulmonary rehabilitation (PR). in this study,
      we'll educate PR to patients and make reservation for re-visiting outpatients clinics with PR
      diary. we want to confirm whether patients, who perform home based PR during more than 30
      minutes in 3 days per week, present improved dyspnea score or quality of life compared with
      non-compliance group.
observational model: Cohort
time perspective: Prospective
measure: Change from basline Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) at 8 weeks
time frame: 8 weeks
description: Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40
measure: change from 6 minutes walk test at 8 weeks
time frame: 8 weeks
description: This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).
measure: Change from the Short Form 36 Health survey (SF-36), version 2.0 at 8 weeks
time frame: 8 weeks
description: a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
measure: Change from BODE index at 8 weeks
time frame: 8 weeks
description: BODE index include forced expiratory volume-one second, 6 minutes walk distance, modified Medical Research Council dyspnea scale, body mass index. The BODE Index is used to predict mortality.
intervention type: Behavioral
intervention name: Pulmonary rehabilitation
description: In this study, we'll educate pulmonary rehabilitation to patients and make reservation for re-visiting outpatients clinics with PR diary after 8 weeks.
we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Sei Won Lee
investigator title: Associate Professor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Undecided