<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/NCT02980575</url>
  </required_header>
  <id_info>
    <org_study_id>16-016-WP</org_study_id>
    <nct_id>NCT02980575</nct_id>
  </id_info>
  <brief_title>Music During Pulmonary Rehabilitation for Patients With COPD</brief_title>
  <official_title>Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Park Healthcare Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Park Healthcare Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed at determining whether listening to music during exercise will improve&#xD;
      health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD).&#xD;
      Half of the participants will listen to music while they exercise and half will not listen to&#xD;
      music. The study will follow participants during their pulmonary rehabilitation program and&#xD;
      for 6 months following completion of the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with chronic obstructive pulmonary disease (COPD) are encouraged to undertake exercise&#xD;
      training as part of their treatment. However, they often find themselves limited by&#xD;
      breathlessness and tiredness in their legs. These barriers limit how much a person may&#xD;
      benefit from an exercise program and how well they may keep up with a recommended schedule of&#xD;
      exercise at home. One way of reducing feelings of breathlessness and leg tiredness is by&#xD;
      listening to music during exercise.&#xD;
&#xD;
      The impact of adding music to exercise versus exercise alone has not been explored in the&#xD;
      setting of pulmonary rehabilitation. This study is aimed at determining the effect of&#xD;
      listening to music during exercise sessions on exercise capacity, symptom severity, quality&#xD;
      of life and motivation to exercise.&#xD;
&#xD;
      People with COPD will be randomly allocated to exercise plus music or exercise alone. A music&#xD;
      therapist will aid with music selection for the exercise plus music group and the music will&#xD;
      be loaded onto a portable device that participants will listen to with earbuds. All&#xD;
      participants will complete assessments before starting a pulmonary rehabilitation program, at&#xD;
      the end of the 8-10 week program and 6 months following completion of the program. They will&#xD;
      complete walking tests, report symptom severity and complete a series of questionnaires&#xD;
      asking about their quality of life, symptoms and keenness to exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in end 6-minute walk test dyspnea and fatigue levels</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 month follow-up</time_frame>
    <description>End test dyspnea and fatigue levels from best 6MWT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional dyspnea profile</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 months follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in chronic respiratory disease questionnaire scores</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hospital anxiety and depression scale score</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in multidimensional fatigue inventory score</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity enjoyment scale score</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in StepWatch physical acitvity monitor results</measure>
    <time_frame>Change from baseline to end of 8-week PR program or 6 month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Exercise with music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will listen to music when they exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will not listen to music when they exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music</intervention_name>
    <arm_group_label>Exercise with music</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_label>Exercise with music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical diagnosis of COPD (physician diagnosis and spirometry with FEV1/FVC ratio &lt;70)&#xD;
             and smoking history of greater than 10 pack years&#xD;
&#xD;
          -  Stable clinical state, with no acute exacerbations over the last 6 weeks&#xD;
&#xD;
          -  Referred to pulmonary rehabilitation program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Predominant diagnosis other than COPD (asthma, bronchiectasis, interstitial lung&#xD;
             disease)&#xD;
&#xD;
          -  Co-morbidities (orthopaedic, neurological, cardiac) which might prevent safe exercise&#xD;
             training&#xD;
&#xD;
          -  Substantial hearing difficulties (inability to hear music adequately)&#xD;
&#xD;
          -  Regularly uses music when exercising&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Craigiburn Community Health Centre</name>
      <address>
        <city>Craigieburn</city>
        <state>Victoria</state>
        <zip>3064</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Park Healthcare Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6M 2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Park Healthcare Centre</investigator_affiliation>
    <investigator_full_name>Roger Goldstein</investigator_full_name>
    <investigator_title>Respirologist</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Music</keyword>
  <keyword>Exercise</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>
  <patient_data>
    <sharing_ipd>No</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/NCT02980575
org study id: 16-016-WP
nct id: NCT02980575
lead sponsor: 
has dmc: No
This study is aimed at determining whether listening to music during exercise will improve
      health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD).
      Half of the participants will listen to music while they exercise and half will not listen to
      music. The study will follow participants during their pulmonary rehabilitation program and
      for 6 months following completion of the program.
People with chronic obstructive pulmonary disease (COPD) are encouraged to undertake exercise
      training as part of their treatment. However, they often find themselves limited by
      breathlessness and tiredness in their legs. These barriers limit how much a person may
      benefit from an exercise program and how well they may keep up with a recommended schedule of
      exercise at home. One way of reducing feelings of breathlessness and leg tiredness is by
      listening to music during exercise.

      The impact of adding music to exercise versus exercise alone has not been explored in the
      setting of pulmonary rehabilitation. This study is aimed at determining the effect of
      listening to music during exercise sessions on exercise capacity, symptom severity, quality
      of life and motivation to exercise.

      People with COPD will be randomly allocated to exercise plus music or exercise alone. A music
      therapist will aid with music selection for the exercise plus music group and the music will
      be loaded onto a portable device that participants will listen to with earbuds. All
      participants will complete assessments before starting a pulmonary rehabilitation program, at
      the end of the 8-10 week program and 6 months following completion of the program. They will
      complete walking tests, report symptom severity and complete a series of questionnaires
      asking about their quality of life, symptoms and keenness to exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in end 6-minute walk test dyspnea and fatigue levels
time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
description: End test dyspnea and fatigue levels from best 6MWT
measure: Multidimensional dyspnea profile
time frame: Change from baseline to end of 8-week PR program or 6 months follow-up
measure: Change in chronic respiratory disease questionnaire scores
time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in hospital anxiety and depression scale score
time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in multidimensional fatigue inventory score
time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in physical activity enjoyment scale score
time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in StepWatch physical acitvity monitor results
time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
arm group label: Exercise with music
arm group type: Experimental
description: Participants will listen to music when they exercise
arm group label: Exercise
arm group type: Active Comparator
description: Participants will not listen to music when they exercise
intervention type: Other
intervention name: Music
arm group label: Exercise with music
intervention type: Other
intervention name: Exercise
arm group label: Exercise
arm group label: Exercise with music
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Australia
country: Canada
responsible party type: Principal Investigator
investigator affiliation: West Park Healthcare Centre
investigator full name: Roger Goldstein
investigator title: Respirologist
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No