<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/NCT03252873</url>
  </required_header>
  <id_info>
    <org_study_id>IzmirKCU2</org_study_id>
    <nct_id>NCT03252873</nct_id>
  </id_info>
  <brief_title>THE FACTORS AFFECTING THE ADHERENCE TO THE PULMONARY REHABILITATION PROGRAM IN COPD</brief_title>
  <official_title>INVESTIGATION THE FACTORS AFFECTING THE ADHERENCE TO THE OUTPATIENT PULMONARY REHABILITATION PROGRAM IN COPD</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>
      Investigators will compare the factors affecting the adherence to the outpatient pulmonary&#xD;
      rehabilitation program in COPD patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to&#xD;
      participate in the exercise program by a team of experts included in this study.&#xD;
&#xD;
      Demographic and clinical characteristics of patients were recorded before the pulmonary&#xD;
      rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood&#xD;
      gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program&#xD;
      adaptation of those who did not participate in the program or who left the program were&#xD;
      questioned. Patients completing the eight-week PR program will compare with those who did not&#xD;
      complete the program or who did not start the program at the recommended time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Function Test</measure>
    <time_frame>15 minutes</time_frame>
    <description>FEV1 (%) FEV1 /FVC TLCO (%) FEV1 (%), FEV1 /FVC, TLCO (%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Gase Analysis</measure>
    <time_frame>5 minutes</time_frame>
    <description>PAO2, PaCO2, SaO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>10 minutes</time_frame>
    <description>walking distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MMRC Dyspnea Scale</measure>
    <time_frame>5 minutes</time_frame>
    <description>1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SGRQ Questionnaire</measure>
    <time_frame>20 minutes</time_frame>
    <description>Symptom-Activity-Impact- Total</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAD Questionnaire</measure>
    <time_frame>15 minutes</time_frame>
    <description>Anxiety- Depression score</description>
  </secondary_outcome>
  <enrollment type="Actual">359</enrollment>
  <condition>COPD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All COPD patients refered to the pulmonary rehabilitation unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: COPD Patients referred to the outpatient pulmonary rehabilitation unit&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: To be unvolunteer&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 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>adherence</keyword>
  <keyword>pulmonary rehabilitation</keyword>
  <keyword>copd</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/NCT03252873
org study id: IzmirKCU2
nct id: NCT03252873
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators will compare the factors affecting the adherence to the outpatient pulmonary
      rehabilitation program in COPD patients
Patients were referred to the Pulmonary Rehabilitation Unit and were recommended to
      participate in the exercise program by a team of experts included in this study.

      Demographic and clinical characteristics of patients were recorded before the pulmonary
      rehabilitation program. All cases were evaluated by pulmonary function test, arterial blood
      gas analysis, six minute walking test, MMRC Dyspnea Scale. Causes that prevented program
      adaptation of those who did not participate in the program or who left the program were
      questioned. Patients completing the eight-week PR program will compare with those who did not
      complete the program or who did not start the program at the recommended time.
observational model: Cohort
time perspective: Retrospective
measure: Respiratory Function Test
time frame: 15 minutes
description: FEV1 (%) FEV1 /FVC TLCO (%) FEV1 (%), FEV1 /FVC, TLCO (%)
measure: Blood Gase Analysis
time frame: 5 minutes
description: PAO2, PaCO2, SaO2
measure: Six minute walk test
time frame: 10 minutes
description: walking distance
measure: MMRC Dyspnea Scale
time frame: 5 minutes
description: 1-5
measure: SGRQ Questionnaire
time frame: 20 minutes
description: Symptom-Activity-Impact- Total
measure: HAD Questionnaire
time frame: 15 minutes
description: Anxiety- Depression score
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
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.