Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial
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 |
Verified date | April 2024 |
Source | West Park Healthcare Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Craigiburn Community Health Centre | Craigieburn | Victoria |
Canada | West Park Healthcare Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
West Park Healthcare Centre |
Australia, Canada,
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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