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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
NA
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