<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/NCT01715337</url>
  </required_header>
  <id_info>
    <org_study_id>COPD muscle 2011</org_study_id>
    <nct_id>NCT01715337</nct_id>
  </id_info>
  <brief_title>Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients</brief_title>
  <official_title>Effects of Pulmonary Rehabilitation on Muscle Fibre Composition and Capillaries in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schön Klinik Berchtesgadener Land</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Sport University, Cologne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Schön Klinik Berchtesgadener Land</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in&#xD;
      patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a&#xD;
      potential change in muscle fibre composition and in the amount of capillaries in quadriceps&#xD;
      muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes&#xD;
      standardised exercise training, e.g. cycling and strength training for major muscle groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the amount of capillaries in muscle fibre type I</measure>
    <time_frame>change from pre (day 1) to post rehabilitation (day 21)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the amount of capillaries in muscle fibre type IIa</measure>
    <time_frame>Change from pre (day 1) to post rehabilitation (day 21)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the cross-sectional area of muscle fibre type I</measure>
    <time_frame>Change from pre (day 1) to post rehabilitation (day 21)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the cross-sectional area of muscle fibre type IIa</measure>
    <time_frame>Change from pre (day 1) to post rehabilitation (day 21)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>pulmonary rehabilitation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pulmonary rehabilitation</intervention_name>
    <description>3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.</description>
    <arm_group_label>pulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
          -  FEV1%pred. &lt; 50%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute exacerbation&#xD;
&#xD;
          -  exacerbation in the last 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Kenn, Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Klinikum Berchtesgadener Land</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schön Klinik Berchtesgadener Land</name>
      <address>
        <city>Schönau am Königssee</city>
        <zip>83471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 14, 2014</last_update_submitted>
  <last_update_submitted_qc>April 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schön Klinik Berchtesgadener Land</investigator_affiliation>
    <investigator_full_name>Klaus Kenn</investigator_full_name>
    <investigator_title>Head physician (department of pneumology)</investigator_title>
  </responsible_party>
  <keyword>muscle fibre</keyword>
  <keyword>capillary</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>exercise training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT01715337
org study id: COPD muscle 2011
nct id: NCT01715337
lead sponsor: 
collaborator: 
has dmc: No
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in
      patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a
      potential change in muscle fibre composition and in the amount of capillaries in quadriceps
      muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes
      standardised exercise training, e.g. cycling and strength training for major muscle groups.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in the amount of capillaries in muscle fibre type I
time frame: change from pre (day 1) to post rehabilitation (day 21)
measure: Change in the amount of capillaries in muscle fibre type IIa
time frame: Change from pre (day 1) to post rehabilitation (day 21)
measure: Change in the cross-sectional area of muscle fibre type I
time frame: Change from pre (day 1) to post rehabilitation (day 21)
measure: Change in the cross-sectional area of muscle fibre type IIa
time frame: Change from pre (day 1) to post rehabilitation (day 21)
arm group label: pulmonary rehabilitation
arm group type: Other
intervention type: Other
intervention name: pulmonary rehabilitation
description: 3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.
arm group label: pulmonary rehabilitation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Klaus Kenn, Dr. med.
role: Study Chair
affiliation: Klinikum Berchtesgadener Land
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Klaus Kenn
investigator title: Head physician (department of pneumology)
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive