- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02980575
Music During Pulmonary Rehabilitation for Patients With COPD
Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-016-WP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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