<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/NCT01719822</url>
  </required_header>
  <id_info>
    <org_study_id>2012LF002H</org_study_id>
    <nct_id>NCT01719822</nct_id>
  </id_info>
  <brief_title>Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who&#xD;
      perform regular physical activity, have improved health and wellbeing compared with those who&#xD;
      do little exercise. The purpose of the study is to evaluate whether the use of a simple&#xD;
      pedometer (step counter) to set targets for daily physical activity can encourage COPD&#xD;
      patients referred for an 8-week pulmonary exercise based programme (PR) to be more active.&#xD;
      The investigators also want to know whether the use of pedometers during PR can improve&#xD;
      adherence, self-management and outcome in COPD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of time spent in at least moderate physical activity (3&gt;METS equivalent)</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Incremental Shuttle Walk</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Lung Diseases, Obstructive</condition>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Bronchitis, Chronic</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week. In addition they will receive a pedometer with a daily step count target set by a physiotherapist and a written home exercise plan/diary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Yamax Digi-Walker CW-700</intervention_name>
    <description>A pedometer with a daily step count target set by a physiotherapist.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient in whom mobility and lower limb function have been significantly affected&#xD;
             by a neuromuscular disease, severe peripheral vascular disease or amputation&#xD;
&#xD;
          -  Any patient whom the chief investigator feels it is unsafe to exercise (eg. unstable&#xD;
             cardiac disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William DC Man, MRCP, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Respiratory Biomedical Research Unit, Royal Brompton &amp; Harefield NHS Foundation Trust and Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harefield Hospital</name>
      <address>
        <city>Middlesex</city>
        <zip>UB9 6JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer-based intervention on physical activity levels after cardiac rehabilitation: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):105-14. doi: 10.1097/HCR.0b013e31819a01ff.</citation>
    <PMID>19305235</PMID>
  </reference>
  <reference>
    <citation>Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.</citation>
    <PMID>18029834</PMID>
  </reference>
  <reference>
    <citation>Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity modifies smoking-related lung function decline and reduces risk of chronic obstructive pulmonary disease: a population-based cohort study. Am J Respir Crit Care Med. 2007 Mar 1;175(5):458-63. doi: 10.1164/rccm.200607-896OC. Epub 2006 Dec 7.</citation>
    <PMID>17158282</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>May 12, 2015</last_update_submitted>
  <last_update_submitted_qc>May 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Treatment Outcome [E01.789.800]</keyword>
  <keyword>Rehabilitation [N02.421.784]</keyword>
  <keyword>Physical Fitness [I03.621]</keyword>
  <keyword>Lung Diseases, Obstructive [C08.381.495]</keyword>
  <keyword>Pulmonary Disease, Chronic Obstructive [C08.381.495.389]</keyword>
  <keyword>Bronchitis, Chronic [C08.381.495.389.500]</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchitis, Chronic</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Chronic Disease</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/NCT01719822
org study id: 2012LF002H
nct id: NCT01719822
lead sponsor: 
has dmc: No
Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who
      perform regular physical activity, have improved health and wellbeing compared with those who
      do little exercise. The purpose of the study is to evaluate whether the use of a simple
      pedometer (step counter) to set targets for daily physical activity can encourage COPD
      patients referred for an 8-week pulmonary exercise based programme (PR) to be more active.
      The investigators also want to know whether the use of pedometers during PR can improve
      adherence, self-management and outcome in COPD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change from baseline of time spent in at least moderate physical activity (3>METS equivalent)
time frame: 8 weeks
measure: Change from baseline of Incremental Shuttle Walk
time frame: 8 weeks
measure: Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)
time frame: 8 weeks
measure: Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36
time frame: 8 weeks
arm group label: Usual Care
arm group type: No Intervention
description: Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary.
arm group label: Intervention
arm group type: Experimental
description: Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week. In addition they will receive a pedometer with a daily step count target set by a physiotherapist and a written home exercise plan/diary.
intervention type: Device
intervention name: Yamax Digi-Walker CW-700
description: A pedometer with a daily step count target set by a physiotherapist.
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: William DC Man, MRCP, PhD
role: Principal Investigator
affiliation: Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London
facility: 
country: United Kingdom
citation: Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer-based intervention on physical activity levels after cardiac rehabilitation: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):105-14. doi: 10.1097/HCR.0b013e31819a01ff.
PMID: 19305235
citation: Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
PMID: 18029834
citation: Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity modifies smoking-related lung function decline and reduces risk of chronic obstructive pulmonary disease: a population-based cohort study. Am J Respir Crit Care Med. 2007 Mar 1;175(5):458-63. doi: 10.1164/rccm.200607-896OC. Epub 2006 Dec 7.
PMID: 17158282
responsible party type: Sponsor
mesh term: Bronchitis
mesh term: Bronchitis, Chronic
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Chronic Disease