Clinical trial NCT02980575: Music During Pulmonary Rehabilitation for Patients With COPD
Official title: Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Music
Exercise
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in end 6-minute walk test dyspnea and fatigue levels
timeFrame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Multidimensional dyspnea profile
timeFrame: Change from baseline to end of 8-week PR program or 6 months follow-up
Secondary outcomes:
measure: Change in chronic respiratory disease questionnaire scores
timeFrame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in hospital anxiety and depression scale score
timeFrame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in multidimensional fatigue inventory score
timeFrame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in physical activity enjoyment scale score
timeFrame: Change from baseline to end of 8-week PR program or 6 month follow-up
measure: Change in StepWatch physical acitvity monitor results
timeFrame: Change from baseline to end of 8-week PR program or 6 month follow-up
Other outcomes:
Locations:
city: Craigieburn
country: Australia
facility: Craigiburn Community Health Centre
state: Victoria
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
References: