Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001217392
Ethics application status
Approved
Date submitted
14/08/2017
Date registered
21/08/2017
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Date results information initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Music listening during a walking test in chronic obstructive pulmonary disease (COPD)
Scientific title
The impact of listening to music during a constant speed endurance walk in people with COPD
Secondary ID [1] 292650 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 304382 0
Condition category
Condition code
Respiratory 303768 303768 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 303769 303769 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The choice of music from 4 genres (classical, pop, country/western and big band) will be available for participants to select from. Musical options include songs with lyrics and tunes/instrumental only. The choice of music will be determined by the participant.
One practice constant speed endurance test will be undertaken for each participant to become familiar with the protocol and to determine the usual and fast walking speed. Following this, each participant will complete a constant speed endurance test under two conditions (music and no music), with the order randomised.
During the intervention phase, the participant will select their music which will be played via a portable device (ipod Nano) for the duration of the test.
The speed of the endurance walk test will be determined by the usual and fast walking speed of the patient.
This will be undertaken within a closed corridor with minimal traffic in the basement of a hospital.
The wash out period between walking tests will be one week.
Intervention code [1] 298883 0
Treatment: Other
Comparator / control treatment
Participants will complete an endurance test as per the intervention phase, but with no music listened to at any time during the test.
Control group
Active

Outcomes
Primary outcome [1] 303076 0
Endurance time
Timepoint [1] 303076 0
End of each endurance test
Secondary outcome [1] 337837 0
Borg dyspnoea according to the modified Borg scale
Timepoint [1] 337837 0
end of endurance test
Secondary outcome [2] 337908 0
Fatigue level according to modified Borg scale
Timepoint [2] 337908 0
End of endurance test
Secondary outcome [3] 337909 0
Multidimensional dyspnoea profile (standardised and valid questionnaire providing sensory and affective information about dyspnoea)
Timepoint [3] 337909 0
End of the endurance test

Eligibility
Key inclusion criteria
Diagnosis of COPD (FEV1/FVC < 70),
Stable condition
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exacerbation of COPD within last 4 weeks
Hearing loss requiring hearing aids

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)
opaque envelopes prepared by individual not related to study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random sequencing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t-tests or Wilcoxon rank sum

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2017
Actual
25/08/2017
Date of last participant enrolment
Anticipated
18/12/2017
Actual
18/12/2017
Date of last data collection
Anticipated
22/01/2018
Actual
18/01/2018
Sample size
Target
19
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 9145 0
Canada
State/province [1] 9145 0
Ontario

Funding & Sponsors
Funding source category [1] 297278 0
Hospital
Name [1] 297278 0
West Park Healthcare Centre
Country [1] 297278 0
Canada
Primary sponsor type
Hospital
Name
West Park Healthcare Centre
Address
82 Buttonwood Ave, Toronto, M6M 2J5
Country
Canada
Secondary sponsor category [1] 296254 0
None
Name [1] 296254 0
None
Address [1] 296254 0
None
Country [1] 296254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298395 0
Joint West Park healthcare centre - Toronto Central Community Care Access - Toronto Grace health Centre Research Ethics Board
Ethics committee address [1] 298395 0
82 Buttonwood AVenue, Toronto, M6M 2J5
Ethics committee country [1] 298395 0
Canada
Date submitted for ethics approval [1] 298395 0
10/12/2015
Approval date [1] 298395 0
07/01/2016
Ethics approval number [1] 298395 0
15-028-WP

Summary
Brief summary
This study will compare the effect of listening to self-selected music during a constant-speed, endurance walk test in people with COPD, compared to not listening to music. The primary outcome measure is endurance time, followed by dyspnoea and fatigue levels.
Trial website
not applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76942 0
Dr Annemarie Lee
Address 76942 0
West Park Healthcare Centre
82 Buttonwood Ave
Toronto, M6M 2J5
Country 76942 0
Canada
Phone 76942 0
+1 416 243 6000
Fax 76942 0
Email 76942 0
[email protected]
Contact person for public queries
Name 76943 0
Dr Annemarie Lee
Address 76943 0
West Park Healthcare Centre
82 Buttonwood Ave, Toronto, M6M 2J5
Country 76943 0
Canada
Phone 76943 0
+1 416 243 6000
Fax 76943 0
Email 76943 0
[email protected]
Contact person for scientific queries
Name 76944 0
Dr Annemarie Lee
Address 76944 0
West Park Healthcare Centre
82 Buttonwood Ave, Toronto
M6M 2J5
Country 76944 0
Canada
Phone 76944 0
+1 416 243 6000
Fax 76944 0
Email 76944 0
[email protected]

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

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Lee AL, Dolmage T, Rhim M, Goldstein RS, Brooks D.... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Impact of Listening to Music During a High-Intensity Exercise Endurance Test in People With COPD.2018https://dx.doi.org/10.1016/j.chest.2017.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.