NCT02980575

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

6.7 years

First QC Date

November 28, 2016

Last Update Submit

April 26, 2024

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDMusicExercise

Outcome Measures

Primary Outcomes (2)

  • 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

  • Multidimensional dyspnea profile

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

Secondary Outcomes (5)

  • 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

Study Arms (2)

Exercise with music

EXPERIMENTAL

Participants will listen to music when they exercise

Other: MusicOther: Exercise

Exercise

ACTIVE COMPARATOR

Participants will not listen to music when they exercise

Other: Exercise

Interventions

MusicOTHER
Exercise with music
ExerciseOTHER
ExerciseExercise with music

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Craigiburn Community Health Centre

Craigieburn, Victoria, 3064, Australia

Location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

  • Lee AL, Butler SJ, Jung P, Clark IN, Tamplin J, Goldstein RS, Brooks D. Participant-selected music listening during pulmonary rehabilitation in people with chronic obstructive pulmonary disease: A randomised controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291065. doi: 10.1177/14799731241291065.

    PMID: 39367818DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

Music TherapyExercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respirologist

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 2, 2016

Study Start

November 1, 2016

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)AU(1)