Music During Pulmonary Rehabilitation for Patients With COPD

May 5, 2023 updated by: Roger Goldstein, West Park Healthcare Centre

Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Craigieburn, Victoria, Australia, 3064
        • Craigiburn Community Health Centre
    • Ontario
      • Toronto, Ontario, Canada, M6M 2J5
        • West Park Healthcare Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medical diagnosis of COPD (physician diagnosis and spirometry with FEV1/FVC ratio <70) and smoking history of greater than 10 pack years
  • Stable clinical state, with no acute exacerbations over the last 6 weeks
  • Referred to pulmonary rehabilitation program

Exclusion Criteria:

  • Predominant diagnosis other than COPD (asthma, bronchiectasis, interstitial lung disease)
  • Co-morbidities (orthopaedic, neurological, cardiac) which might prevent safe exercise training
  • Substantial hearing difficulties (inability to hear music adequately)
  • Regularly uses music when exercising

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise with music
Participants will listen to music when they exercise
Active Comparator: Exercise
Participants will not listen to music when they exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End test dyspnea and fatigue levels from best 6MWT
Change from baseline to end of 8-week PR program or 6 month follow-up
Multidimensional dyspnea profile
Time Frame: Change from baseline to end of 8-week PR program or 6 months follow-up
Change from baseline to end of 8-week PR program or 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in chronic respiratory disease questionnaire scores
Time Frame: Change from baseline to end of 8-week PR program or 6 month follow-up
Change from baseline to end of 8-week PR program or 6 month follow-up
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
Change from baseline to end of 8-week PR program or 6 month follow-up
Change in multidimensional fatigue inventory score
Time Frame: Change from baseline to end of 8-week PR program or 6 month follow-up
Change from baseline to end of 8-week PR program or 6 month follow-up
Change in physical activity enjoyment scale score
Time Frame: Change from baseline to end of 8-week PR program or 6 month follow-up
Change from baseline to end of 8-week PR program or 6 month follow-up
Change in StepWatch physical acitvity monitor results
Time Frame: Change from baseline to end of 8-week PR program or 6 month follow-up
Change from baseline to end of 8-week PR program or 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-016-WP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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