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Completed

NCT Number: NCT02980575

Music During Pulmonary Rehabilitation for Patients With COPD

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craigiburn Community Health Centre, Craigieburn, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

Exercise

Other

Primary outcomes

  1. Change in end 6-minute walk test dyspnea and fatigue levels

    Time frame: Change from baseline to end of 8-week PR program or 6 month follow-up

    End test dyspnea and fatigue levels from best 6MWT

  2. Multidimensional dyspnea profile

    Time frame: Change from baseline to end of 8-week PR program or 6 months follow-up

Secondary outcomes

  1. Change in chronic respiratory disease questionnaire scores

    Time frame: Change from baseline to end of 8-week PR program or 6 month follow-up

  2. 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

  3. Change in multidimensional fatigue inventory score

    Time frame: Change from baseline to end of 8-week PR program or 6 month follow-up

  4. Change in physical activity enjoyment scale score

    Time frame: Change from baseline to end of 8-week PR program or 6 month follow-up

  5. Change in StepWatch physical acitvity monitor results

    Time frame: Change from baseline to end of 8-week PR program or 6 month follow-up

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2016
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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