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Music During Pulmonary Rehabilitation for Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Music
Exercise
Sponsored by
West Park Healthcare Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Music, Exercise

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Craigiburn Community Health Centre
  • West Park Healthcare Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise with music

Exercise

Arm Description

Participants will listen to music when they exercise

Participants will not listen to music when they exercise

Outcomes

Primary Outcome Measures

Change in end 6-minute walk test dyspnea and fatigue levels
End test dyspnea and fatigue levels from best 6MWT
Multidimensional dyspnea profile

Secondary Outcome Measures

Change in chronic respiratory disease questionnaire scores
Change in hospital anxiety and depression scale score
Change in multidimensional fatigue inventory score
Change in physical activity enjoyment scale score
Change in StepWatch physical acitvity monitor results

Full Information

First Posted
November 28, 2016
Last Updated
May 5, 2023
Sponsor
West Park Healthcare Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02980575
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Music, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise with music
Arm Type
Experimental
Arm Description
Participants will listen to music when they exercise
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Participants will not listen to music when they exercise
Intervention Type
Other
Intervention Name(s)
Music
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Change in end 6-minute walk test dyspnea and fatigue levels
Description
End test dyspnea and fatigue levels from best 6MWT
Time Frame
Change from baseline to end of 8-week PR program or 6 month follow-up
Title
Multidimensional dyspnea profile
Time Frame
Change from baseline to end of 8-week PR program or 6 months follow-up
Secondary Outcome Measure Information:
Title
Change in chronic respiratory disease questionnaire scores
Time Frame
Change from baseline to end of 8-week PR program or 6 month follow-up
Title
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
Title
Change in multidimensional fatigue inventory score
Time Frame
Change from baseline to end of 8-week PR program or 6 month follow-up
Title
Change in physical activity enjoyment scale score
Time Frame
Change from baseline to end of 8-week PR program or 6 month follow-up
Title
Change in StepWatch physical acitvity monitor results
Time Frame
Change from baseline to end of 8-week PR program or 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Craigiburn Community Health Centre
City
Craigieburn
State/Province
Victoria
ZIP/Postal Code
3064
Country
Australia
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Music During Pulmonary Rehabilitation for Patients With COPD

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