<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/NCT03302702</url>
  </required_header>
  <id_info>
    <org_study_id>IKC4</org_study_id>
    <nct_id>NCT03302702</nct_id>
  </id_info>
  <brief_title>Duration of Exercise Program in Interstitial Lung Diseases.</brief_title>
  <official_title>A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Katip Celebi University</source>
  <oversight_info>
    <has_dmc>No</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>
      We aimed to compare the functional results of the 8th week with the results of the 12th week&#xD;
      of the exercise programs applied to the patients with ILD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise programs (EP) have been shown to be the effective approach for functional outcomes&#xD;
      in interstitial lung diseases (ILD). In many studies, the duration of exercise programs&#xD;
      varies between 8-12 weeks. However, the optimal duration of exercise program is still&#xD;
      unknown.&#xD;
&#xD;
      We aimed to compare the results of the 8th week with the results of the 12th week of the PR&#xD;
      programs applied to the patients with ILD.&#xD;
&#xD;
      A total of 14 patients with ILD referred to our PR unit [11 idiopathic pulmonary fibrosis, 2&#xD;
      sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia] were included in the&#xD;
      study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC&#xD;
      dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were&#xD;
      performed before, at the 8th and 12th weeks after the exercise program applied to the&#xD;
      patients twice a week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>6 minute</time_frame>
    <description>It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mMRC</measure>
    <time_frame>5 minutes</time_frame>
    <description>It was used for dyspnea that patients felt during their daily activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Function Test</measure>
    <time_frame>20 minutes</time_frame>
    <description>It was used for assessment of lung functions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SGRQ</measure>
    <time_frame>30 minutes</time_frame>
    <description>A disease-specific quality of life scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 Health Survey</measure>
    <time_frame>30 minutes</time_frame>
    <description>A health related quality of life scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Inventory</measure>
    <time_frame>20 minutes</time_frame>
    <description>It was used for assessment of anxiety and depression</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Exercise program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise program</intervention_name>
    <description>Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training</description>
    <arm_group_label>Exercise program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed the 12 week exercise program&#xD;
&#xD;
          -  Diagnosed with ILD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not completed 12 week exercise program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 1, 2017</last_update_submitted>
  <last_update_submitted_qc>October 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Katip Celebi University</investigator_affiliation>
    <investigator_full_name>Ilknur Naz</investigator_full_name>
    <investigator_title>Asst. Prof</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>duration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT03302702
org study id: IKC4
nct id: NCT03302702
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We aimed to compare the functional results of the 8th week with the results of the 12th week
      of the exercise programs applied to the patients with ILD.
Exercise programs (EP) have been shown to be the effective approach for functional outcomes
      in interstitial lung diseases (ILD). In many studies, the duration of exercise programs
      varies between 8-12 weeks. However, the optimal duration of exercise program is still
      unknown.

      We aimed to compare the results of the 8th week with the results of the 12th week of the PR
      programs applied to the patients with ILD.

      A total of 14 patients with ILD referred to our PR unit [11 idiopathic pulmonary fibrosis, 2
      sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia] were included in the
      study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC
      dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were
      performed before, at the 8th and 12th weeks after the exercise program applied to the
      patients twice a week.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Six minute walk test
time frame: 6 minute
description: It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria
measure: mMRC
time frame: 5 minutes
description: It was used for dyspnea that patients felt during their daily activities.
measure: Pulmonary Function Test
time frame: 20 minutes
description: It was used for assessment of lung functions
measure: SGRQ
time frame: 30 minutes
description: A disease-specific quality of life scale
measure: SF-36 Health Survey
time frame: 30 minutes
description: A health related quality of life scale
measure: Hospital Anxiety and Depression Inventory
time frame: 20 minutes
description: It was used for assessment of anxiety and depression
arm group label: Exercise program
arm group type: Other
description: Treatment group
intervention type: Other
intervention name: Exercise program
description: Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training
arm group label: Exercise program
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Izmir Katip Celebi University
investigator full name: Ilknur Naz
investigator title: Asst. Prof
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
sharing ipd: No