<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/NCT03227341</url>
  </required_header>
  <id_info>
    <org_study_id>KCU123</org_study_id>
    <nct_id>NCT03227341</nct_id>
  </id_info>
  <brief_title>Pulmonary Rehabilitation in Asthma Control</brief_title>
  <official_title>Does Pulmonary Rehabilitation Contribute to Asthma Control?</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>
      The investigators compared the effectiveness of pulmonary rehabilitation program on asthma&#xD;
      control in patients with uncontrolled and partially controlled asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma treatment is not only medical, it also requires a comprehensive care including&#xD;
      nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of&#xD;
      the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary&#xD;
      rehabilitation in patients with uncontrolled and partially controlled asthma.&#xD;
&#xD;
      Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to&#xD;
      asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients&#xD;
      (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control&#xD;
      tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality&#xD;
      of life, exercise capacity, anxiety and depression assessments were performed before and&#xD;
      after pulmonary rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma control test score</measure>
    <time_frame>4 weeks</time_frame>
    <description>A test measured the control of asthma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>6 minute</time_frame>
    <description>Six minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>1 year</time_frame>
    <description>MMRC Dyspnea Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>1 year</time_frame>
    <description>St. George Respiratory Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Function Test</measure>
    <time_frame>1 hour</time_frame>
    <description>FEV1, FVC, DLCO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Blood Gas</measure>
    <time_frame>1 hour</time_frame>
    <description>PaO2, PaCO2, SaO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>1 week</time_frame>
    <description>Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>patients with uncontrolled asthma.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>8 week pulmonary rehabilitation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with partially controlled asthma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>8 week pulmonary rehabilitation program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises. In addition, bronchial hygiene techniques and dyspnea-reducing positions</description>
    <arm_group_label>patients with partially controlled asthma</arm_group_label>
    <arm_group_label>patients with uncontrolled asthma.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation&#xD;
             unit was confirmed according to GINA guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the initial diagnosis cannot be confirmed, the patient excluded from the study&#xD;
&#xD;
          -  Patients were under medical treatment of -6 months and considered clinically stable.&#xD;
&#xD;
          -  Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary&#xD;
             tuberculosis, interstitial lung disease), or musculoskeletal diseases that would&#xD;
             impair exercise training were excluded from the study.&#xD;
&#xD;
          -  Also subjects with lack of motivation, poor compliance (not attending the program more&#xD;
             than 2 times) or having transport problems were excluded from the study&#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>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 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. Ilknur NAZ</investigator_title>
  </responsible_party>
  <keyword>asthma control</keyword>
  <keyword>pulmonary rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT03227341
org study id: KCU123
nct id: NCT03227341
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators compared the effectiveness of pulmonary rehabilitation program on asthma
      control in patients with uncontrolled and partially controlled asthma.
Asthma treatment is not only medical, it also requires a comprehensive care including
      nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of
      the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary
      rehabilitation in patients with uncontrolled and partially controlled asthma.

      Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to
      asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients
      (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control
      tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality
      of life, exercise capacity, anxiety and depression assessments were performed before and
      after pulmonary rehabilitation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Asthma control test score
time frame: 4 weeks
description: A test measured the control of asthma
measure: Exercise capacity
time frame: 6 minute
description: Six minute walk test
measure: Dyspnea
time frame: 1 year
description: MMRC Dyspnea Scale
measure: Quality of Life
time frame: 1 year
description: St. George Respiratory Questionnaire
measure: Pulmonary Function Test
time frame: 1 hour
description: FEV1, FVC, DLCO
measure: Arterial Blood Gas
time frame: 1 hour
description: PaO2, PaCO2, SaO2
measure: Anxiety and Depression
time frame: 1 week
description: Hospital Anxiety and Depression Scale
arm group label: patients with uncontrolled asthma.
arm group type: Other
description: 8 week pulmonary rehabilitation program
arm group label: patients with partially controlled asthma
arm group type: Other
description: 8 week pulmonary rehabilitation program
intervention type: Other
intervention name: Exercise
description: 8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises. In addition, bronchial hygiene techniques and dyspnea-reducing positions
arm group label: patients with partially controlled asthma
arm group label: patients with uncontrolled asthma.
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. Ilknur NAZ
mesh term: Asthma
sharing ipd: Undecided