Chronic Obstructive Pulmonary DiseaseNCT02980575
Music During Pulmonary Rehabilitation for Patients With COPD
A study testing Music and Exercise in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Music and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2016to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Craigiburn Community Health Centre
Craigieburn, Victoria, 3064
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Music, Exercise
- Keywords
- COPD, Music, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise with music | Experimental | Participants will listen to music when they exercise Receives: Other: Music; Other: Exercise |
| Exercise | Active comparator | Participants will not listen to music when they exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end 6-minute walk test dyspnea and fatigue levels
End test dyspnea and fatigue levels from best 6MWT
Measured: Change from baseline to end of 8-week PR program or 6 month follow-up
Multidimensional dyspnea profile
Measured: Change from baseline to end of 8-week PR program or 6 months follow-up
Secondary outcomes (5)
Change in chronic respiratory disease questionnaire scores
Measured: Change from baseline to end of 8-week PR program or 6 month follow-up
Change in hospital anxiety and depression scale score
Measured: Change from baseline to end of 8-week PR program or 6 month follow-up
Change in multidimensional fatigue inventory score
Measured: Change from baseline to end of 8-week PR program or 6 month follow-up
Change in physical activity enjoyment scale score
Measured: Change from baseline to end of 8-week PR program or 6 month follow-up
Change in StepWatch physical acitvity monitor results
Measured: Change from baseline to end of 8-week PR program or 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980575
- Sponsor's protocol ID
- 16-016-WP
- Status last verified
- Apr 2024
- First submitted
- 28 Nov 2016
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee AL, Butler SJ, Jung P, Clark IN, Tamplin J, Goldstein RS, Brooks D. Participant-selected music listening during pulmonary rehabilitation in people with chronic obstructive pulmonary disease: A randomised controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291065. doi: 10.1177/14799731241291065.
PubMed 39367818
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02980575
- Acronym / sponsor ID
- 16-016-WP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Music, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with music | Experimental | Other: Music, Other: ExerciseParticipants will listen to music when they exercise |
| Exercise | Active comparator | Other: ExerciseParticipants will not listen to music when they exercise |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music | Other | Exercise with music |
| Exercise | Other | Exercise, Exercise with music |
Primary outcome
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
Multidimensional dyspnea profile
Time frame: Change from baseline to end of 8-week PR program or 6 months follow-up
5 secondary outcomes
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 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 in multidimensional fatigue inventory score
Time frame: 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 in StepWatch physical acitvity monitor results
Time frame: Change from baseline to end of 8-week PR program or 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 39367818Lee AL, Butler SJ, Jung P, Clark IN, Tamplin J, Goldstein RS, Brooks D. Participant-selected music listening during pulmonary rehabilitation in people with chronic obstructive pulmonary disease: A randomised controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291065. doi: 10.1177/14799731241291065.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Exercise in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.