Music During Pulmonary Rehabilitation for Patients With COPD

Sponsor

West Park Healthcare Centre (Other)

Overall Status

Suspended

CT.gov ID

NCT02980575

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: Music Other: Exercise	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial

Actual Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise with music Participants will listen to music when they exercise	Other: Music Other: Exercise
Active Comparator: Exercise Participants will not listen to music when they exercise	Other: Exercise

Arm

Intervention/Treatment

Experimental: Exercise with music

Participants will listen to music when they exercise

Other: Music

Other: Exercise

Active Comparator: Exercise

Participants will not listen to music when they exercise

Other: Exercise

Outcome Measures

Primary Outcome Measures

Change in end 6-minute walk test dyspnea and fatigue levels [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 [Change from baseline to end of 8-week PR program or 6 months follow-up]

Secondary Outcome Measures

Change in chronic respiratory disease questionnaire scores [Change from baseline to end of 8-week PR program or 6 month follow-up]
Change in hospital anxiety and depression scale score [Change from baseline to end of 8-week PR program or 6 month follow-up]
Change in multidimensional fatigue inventory score [Change from baseline to end of 8-week PR program or 6 month follow-up]
Change in physical activity enjoyment scale score [Change from baseline to end of 8-week PR program or 6 month follow-up]
Change in StepWatch physical acitvity monitor results [Change from baseline to end of 8-week PR program or 6 month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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