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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02980575
Other study ID # 16-016-WP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date June 30, 2023

Study information

Verified date April 2024
Source West Park Healthcare Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study will follow participants during their pulmonary rehabilitation program and for 6 months following completion of the program.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Music

Exercise


Locations

Country Name City State
Australia Craigiburn Community Health Centre Craigieburn Victoria
Canada West Park Healthcare Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
West Park Healthcare Centre

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in end 6-minute walk test dyspnea and fatigue levels End test dyspnea and fatigue levels from best 6MWT Change from baseline to end of 8-week PR program or 6 month follow-up
Primary Multidimensional dyspnea profile Change from baseline to end of 8-week PR program or 6 months follow-up
Secondary Change in chronic respiratory disease questionnaire scores Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary Change in hospital anxiety and depression scale score Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary Change in multidimensional fatigue inventory score Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary Change in physical activity enjoyment scale score Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary Change in StepWatch physical acitvity monitor results Change from baseline to end of 8-week PR program or 6 month follow-up
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