Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02980575




Registration number
NCT02980575
Ethics application status
Date submitted
28/11/2016
Date registered
2/12/2016

Titles & IDs
Public title
Music During Pulmonary Rehabilitation for Patients With COPD
Scientific title
Does Music During Pulmonary Rehabilitation in Individuals With Chronic Obstructive Pulmonary Disease (COPD) Improve Outcome? A Randomized Controlled Trial
Secondary ID [1] 0 0
16-016-WP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Exercise with music - Participants will listen to music when they exercise

Active comparator: Exercise - Participants will not listen to music when they exercise
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in end 6-minute walk test dyspnea and fatigue levels
Timepoint [1] 0 0
Change from baseline to end of 8-week PR program or 6 month follow-up
Primary outcome [2] 0 0
Multidimensional dyspnea profile
Timepoint [2] 0 0
Change from baseline to end of 8-week PR program or 6 months follow-up
Secondary outcome [1] 0 0
Change in chronic respiratory disease questionnaire scores
Timepoint [1] 0 0
Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary outcome [2] 0 0
Change in hospital anxiety and depression scale score
Timepoint [2] 0 0
Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary outcome [3] 0 0
Change in multidimensional fatigue inventory score
Timepoint [3] 0 0
Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary outcome [4] 0 0
Change in physical activity enjoyment scale score
Timepoint [4] 0 0
Change from baseline to end of 8-week PR program or 6 month follow-up
Secondary outcome [5] 0 0
Change in StepWatch physical acitvity monitor results
Timepoint [5] 0 0
Change from baseline to end of 8-week PR program or 6 month follow-up

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Craigiburn Community Health Centre - Craigieburn
Recruitment postcode(s) [1] 0 0
3064 - Craigieburn
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
West Park Healthcare Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02980575