<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/NCT03003208</url>
  </required_header>
  <id_info>
    <org_study_id>16/0446</org_study_id>
    <nct_id>NCT03003208</nct_id>
  </id_info>
  <brief_title>Pulmonary Rehabilitation and Cardiovascular Risk in COPD</brief_title>
  <official_title>Pulmonary Rehabilitation and Cardiovascular Risk in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.&#xD;
      Patients with COPD are at increased risk of developing cardiovascular disease such as heart&#xD;
      attacks and strokes. A simple measurement called arterial stiffness is a good assessment of&#xD;
      how likely people are to have cardiovascular disease, both in healthy populations and those&#xD;
      with COPD. Aortic Pulse wave velocity (aPWV) measures arterial stiffness,&#xD;
&#xD;
      Pulmonary Rehabilitation (PR) - a 6 week supervised group exercise and education class - is&#xD;
      an effective intervention in COPD to reduce symptoms, improve exercise performance and&#xD;
      prevent exacerbations. However, the effect of PR on cardiovascular risk in COPD is&#xD;
      controversial as two small positive studies suggested benefit and one larger study did not.&#xD;
&#xD;
      Investigators have recently shown that cardiovascular risk is higher in those COPD patients&#xD;
      who get the most infections (exacerbations). PR is an effective intervention for preventing&#xD;
      COPD exacerbations. Logically, the exercise component would be expected to reduce&#xD;
      cardiovascular risk too.&#xD;
&#xD;
      Investigators want to identify which patients with COPD get cardiovascular benefit from a PR&#xD;
      programme and why others do not. Investigators propose to measure aPWV before and after PR.&#xD;
      Investigators will then classify participants as responders or non-responders defined as the&#xD;
      presence or absence of a significant improvement in aPWV. Investigators will be collecting&#xD;
      demographic and clinical information including daily physical activity level and how&#xD;
      effective the PR has been to enable the investigators to identify the characteristics of&#xD;
      patients who do, and do not achieve cardiovascular risk reduction in response to PR in COPD.&#xD;
      This will inform on better design of PR programmes for people living with COPD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 21, 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial stiffness</measure>
    <time_frame>6 weeks</time_frame>
    <description>aortic pulse wave velocity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Incremental Shuttle Walk Test (ISWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>6 weeks</time_frame>
    <description>steps counter pedometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea</measure>
    <time_frame>6 weeks</time_frame>
    <description>Medical Research Council (MRC) dyspnoea scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient quality of life</measure>
    <time_frame>6 weeks</time_frame>
    <description>COPD (CAT) assessment test</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>COPD</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>An exercise and education program</description>
    <arm_group_label>Pulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient diagnosed with COPD. The patient must be referred to PR from his/her physician&#xD;
             with spirometry results confirming that he/she has chronic obstructive pulmonary&#xD;
             disease (defined as post-bronchodilator FEV1/VC &lt;0.70 and a compatible exposure&#xD;
             history).&#xD;
&#xD;
          -  Ability to exercise.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular diagnosis.&#xD;
&#xD;
          -  Patient involved in any ongoing drug intervention study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Free Hospital NHS</name>
      <address>
        <city>London</city>
        <state>Nw3 2pf</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03003208
org study id: 16/0446
nct id: NCT03003208
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.
      Patients with COPD are at increased risk of developing cardiovascular disease such as heart
      attacks and strokes. A simple measurement called arterial stiffness is a good assessment of
      how likely people are to have cardiovascular disease, both in healthy populations and those
      with COPD. Aortic Pulse wave velocity (aPWV) measures arterial stiffness,

      Pulmonary Rehabilitation (PR) - a 6 week supervised group exercise and education class - is
      an effective intervention in COPD to reduce symptoms, improve exercise performance and
      prevent exacerbations. However, the effect of PR on cardiovascular risk in COPD is
      controversial as two small positive studies suggested benefit and one larger study did not.

      Investigators have recently shown that cardiovascular risk is higher in those COPD patients
      who get the most infections (exacerbations). PR is an effective intervention for preventing
      COPD exacerbations. Logically, the exercise component would be expected to reduce
      cardiovascular risk too.

      Investigators want to identify which patients with COPD get cardiovascular benefit from a PR
      programme and why others do not. Investigators propose to measure aPWV before and after PR.
      Investigators will then classify participants as responders or non-responders defined as the
      presence or absence of a significant improvement in aPWV. Investigators will be collecting
      demographic and clinical information including daily physical activity level and how
      effective the PR has been to enable the investigators to identify the characteristics of
      patients who do, and do not achieve cardiovascular risk reduction in response to PR in COPD.
      This will inform on better design of PR programmes for people living with COPD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: arterial stiffness
time frame: 6 weeks
description: aortic pulse wave velocity
measure: Exercise capacity
time frame: 6 weeks
description: Incremental Shuttle Walk Test (ISWT)
measure: Physical activity level
time frame: 6 weeks
description: steps counter pedometer
measure: Change in dyspnea
time frame: 6 weeks
description: Medical Research Council (MRC) dyspnoea scale
measure: patient quality of life
time frame: 6 weeks
description: COPD (CAT) assessment test
arm group label: Pulmonary rehabilitation
arm group type: Other
intervention type: Other
intervention name: Pulmonary rehabilitation
description: An exercise and education program
arm group label: Pulmonary rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor