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Trial registered on ANZCTR


Registration number
ACTRN12619001346167p
Ethics application status
Submitted, not yet approved
Date submitted
12/09/2019
Date registered
1/10/2019
Date last updated
1/10/2019
Date data sharing statement initially provided
1/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term fatigue and recovery during instrumental music performance
Scientific title
Rates of fatigability and recovery in instrumental musicians: Quantification and basis for work:rest ratio development
Secondary ID [1] 299231 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigability 314357 0
Repetitive strain injury 314358 0
Physical overload 314361 0
Psychological overload 314362 0
Condition category
Condition code
Injuries and Accidents 312693 312693 0 0
Other injuries and accidents
Mental Health 312694 312694 0 0
Other mental health disorders
Musculoskeletal 312890 312890 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend the research facilities for a one-off 1.5-2 hour cross-sectional testing session administered by an exercise physiologist experienced in collecting data from musicians. Following informed consent, each testing session will begin with the application of wireless surface electromyographic (EMG) electrodes to performance-related and postural support muscles relevant to each instrumental group (upper strings, lower strings, piano, brass). Participants will then perform a series of maximum voluntary exertions (MVE) to determine the maximum neuroelectric output (EMGmax) of each investigated muscle. Next, two maximum voluntary contraction (MVC) tests will be conducted to determine the maximum force output of postural support and performance muscles, respectively. Following MVC tests, participants will be asked to perform, for 10 minutes each and in random order, pre-prepared repertoire that they have rated to be physically/technically ‘very light’ (Borg rating of perceived exertion (RPE) = 9/20), ‘somewhat hard’ (RPE = 13/20), and ‘very difficult’ (RPE = 17/20). Imediately following each repertoire performance, additional MVC tests will be performed to evaluate fatigability-related changes in postural support and performance muscles. Repertoire performances and MVC tests will be performed sequentially, with no rest period in between. After the final repertoire performance and subsequent MVCs, participants will sit silently for 10 minutes before performing one final set of MVCs to determine recovery rates.
Intervention code [1] 315529 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321341 0
Maximum voluntary contraction force - performance muscles; assessed using grip strength goniometer (upper strings, lower strings, piano) or the Jericho Lip Expander (quantitative force measurement device for embouchure muscles in brass instrumentalists)
Timepoint [1] 321341 0
Baseline, immediately Post-repertoire 1, immediately Post-repertoire 2, immediately Post-repertoire 3, Post-10 minute recovery
Primary outcome [2] 321342 0
Maximum voluntary contraction force - postural muscles; assessed using hand held goniometer
Timepoint [2] 321342 0
Baseline, immediately Post-repertoire 1, immediately Post-repertoire 2, immediately Post-repertoire 3, Post-10 mins recovery
Secondary outcome [1] 374703 0
Mean electromyographic amplitude during maximum voluntary contraction tests
Timepoint [1] 374703 0
Baseline, immediately Post-repertoire 1, immediately Post-repertoire 2, immediately Post-repertoire 3, Post-10 mins recovery

Eligibility
Key inclusion criteria
University or professional instrumental musicians
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of a playing-related musculoskeletal disorder at time of testing

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Demographic and EMG data during each excerpt will reported using descriptive statistics (e.g. mean, standard deviation, 95% confidence interval) for the entire cohort, as well as within each instrumental sub-group. Fatigability and recovery rates will be estimated by evaluating changes in force and EMG amplitude during MVC tests. Differences in fatigue and recovery rates between instrumental groups will be calculated using independent samples t-tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 21853 0
Germany
State/province [1] 21853 0
Niedersachsen

Funding & Sponsors
Funding source category [1] 303770 0
Charities/Societies/Foundations
Name [1] 303770 0
Alexander von Humboldt Foundation
Country [1] 303770 0
Germany
Primary sponsor type
Individual
Name
Dr. J. Matt McCrary
Address
Institute of Music Physiology and Musicians' Medicine
Hannover University of Music, Drama and Media
Neues Haus 1
30175 Hannover
Country
Germany
Secondary sponsor category [1] 303891 0
None
Name [1] 303891 0
Address [1] 303891 0
Country [1] 303891 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304291 0
Central Ethics Committee - Leibniz Universität Hannover
Ethics committee address [1] 304291 0
Ethics committee country [1] 304291 0
Germany
Date submitted for ethics approval [1] 304291 0
18/09/2019
Approval date [1] 304291 0
Ethics approval number [1] 304291 0

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

Contacts
Principal investigator
Name 96418 0
Dr J. Matt McCrary
Address 96418 0
Institute for Music Physiology and Musicians' Medicine
Hannover University of Music, Drama and Media
Neues Haus 1
30175 Hannover
Country 96418 0
Germany
Phone 96418 0
+49 178 6899834
Fax 96418 0
Email 96418 0
[email protected]
Contact person for public queries
Name 96419 0
J. Matt McCrary
Address 96419 0
Institute for Music Physiology and Musicians' Medicine
Hannover University of Music, Drama and Media
Neues Haus 1
30175 Hannover
Country 96419 0
Germany
Phone 96419 0
+49 178 6899834
Fax 96419 0
Email 96419 0
[email protected]
Contact person for scientific queries
Name 96420 0
J. Matt McCrary
Address 96420 0
Institute for Music Physiology and Musicians' Medicine
Hannover University of Music, Drama and Media
Neues Haus 1
30175 Hannover
Country 96420 0
Germany
Phone 96420 0
+49 178 6899834
Fax 96420 0
Email 96420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified participant data
When will data be available (start and end dates)?
Starting on the publication date of the main study results for a period of ten years.
Available to whom?
Available on request to researchers and journal editors. Responses to other data requests will be determined on a case-by-case basis.
Available for what types of analyses?
Any analysis
How or where can data be obtained?
Data can be obtained by contacting the primary investigator ([email protected]) following the publication of main study results


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcute Neuromuscular Fatigability and Perceived Exertion in High-Level University Pianists: An Electromyography and Maximum Force Capacity Study.2023https://dx.doi.org/10.21091/mppa.2023.2015
N.B. These documents automatically identified may not have been verified by the study sponsor.