Trial Review

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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 registered on ANZCTR


Registration number
ACTRN12619001108101
Ethics application status
Approved
Date submitted
18/07/2019
Date registered
12/08/2019
Date last updated
7/12/2020
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Test of a fatigue self-management tool for instrumental musicians
Scientific title
Fatigue management in instrumental musicians: Validity and efficacy of an online monitoring tool
Secondary ID [1] 298771 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Playing-related fatigue (musician) 313713 0
Overuse / Overload 313714 0
Condition category
Condition code
Public Health 312124 312124 0 0
Other public health
Injuries and Accidents 312190 312190 0 0
Other injuries and accidents
Mental Health 312191 312191 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Professional or university instrumental musicians will enter the following data or perform the following tests daily or, at a minimum, bi-weekly (unless otherwise indicated) over an active sampling period of 6-months:
1) Session rating of perceived exertion (sRPE) - duration and intensity of the participant's day of instrumental music practice/rehearsal/performance
2) Visual analogue scales - ratings of physical and psychological stress
3) Pain or injury incidence - initially a yes / no question, with a 'yes' response prompting the participant to complete the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians
4) Self-rated musical performance quality - visual analogue scale
5) Recognition reaction time test - psychomotor performance
6) Grip strength test - physical performance (*this test to be performed weekly*)

Daily inputs into the monitoring tool have been designed to take 1-2 minutes for participants to complete, and will require participants to access an online form containing items 1-5 above. Weekly grip strength tests will be performed at the location of regular rehearsals or performances. Adherence to monitoring tool inputs and grip strength test will be monitored by online entry and grip strongly test attendance logs, respectively.

Participants will receive weekly study emails containing 1) information relevant to musicians’ health and wellbeing delivered in a standardised order; and 2) personalised encouragement based on individual participation rates and patterns.
Intervention code [1] 315039 0
Diagnosis / Prognosis
Intervention code [2] 315176 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320760 0
Sum score of visual analogue scale ratings of physical and psychological stress
Timepoint [1] 320760 0
Assessed daily or, at a minimum, bi-weekly throughout 6-month sampling period. Primary timepoint depends on incidence of overreach during the sampling period. For participants with an incidence of overreach during the sampling period, the primary timepoint is the date of overreach onset. For participants without an incidence of overreach during the sampling period, no primary timepoint is assigned and mean values throughout the sampling period will be used for analysis.
Secondary outcome [1] 372754 0
Playing load - session rating of perceived exertion (sRPE)
Timepoint [1] 372754 0
Assessed daily or, at a minimum, bi-weekly post-enrollment throughout 6-month sampling period
Secondary outcome [2] 372755 0
Musical performance - self-rated visual analogue scale
Timepoint [2] 372755 0
Assessed daily or, at a minimum, bi-weekly post-enrollment throughout 6-month sampling period
Secondary outcome [3] 372756 0
Psychomotor performance - recognition reaction time test assessed via study-specific online platform
Timepoint [3] 372756 0
Assessed daily or, at a minimum, bi-weekly throughout 6-month post-enrollment sampling period
Secondary outcome [4] 372757 0
Physical performance - grip strength test assessed using hand dynamometer
Timepoint [4] 372757 0
Assessed weekly post-enrollment throughout 6-month sampling period
Secondary outcome [5] 372758 0
Playing-related musculoskeletal disorder incidence - modified Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians
Timepoint [5] 372758 0
Assessed daily or, at a minimum, bi-weekly post-enrollment throughout 6-month sampling period

Eligibility
Key inclusion criteria
University or professional instrumental musicians (demonstrated expertise)
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 study registration

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size
This study is powered to detect a significant difference in weekly change in the sum of visual analogue scale ratings of physical/psychological stress between acutely fatigued vs. overloaded participants. A prior study of a self-report fatigue monitoring tool using visual analogue scale data in cyclists reported a significant difference in weekly change in fatigue and ‘readiness to train’ (d=1.39; p=.02) in in overloaded vs. acutely fatigued cyclists. Using these data, a two-tailed a=.05, 95% power and a conservative 50% adjustment for non-compliance (anticipated reduced compliance due to online survey platform and long survey duration), 136 participants are required. Given the uncertainty regarding the incidence of overload in instrumentalists (and thus the distribution between acutely fatigued & overloaded participants), this sample size is regarded as the minimum viable sample size and as many participants as possible will be recruited over the study duration.

Analysis plan
The primary outcome will be compared between participants who did vs. did not display signs of overload during their data sampling time period using a two-sample t-test. ‘Overload’ is defined as a decrease in one or more performance outcomes (musical, psychomotor, physical) equal to or greater than the ‘Smallest Worthwhile Change’ = 0.3 * baseline coefficient of variation. The average change in composite visual analogue scale ratings will be used for participants who did not display signs of overload. For participants displaying signs of overload, the change in composite VAS indicator score will be used for the week immediately preceding the performance decrement. Secondary outcomes will be analysed using t-tests and regression models as appropriate. An a=.05 will be used for all analyses and all effects will be presented with 95% confidence intervals where possible.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
17/02/2020
Date of last participant enrolment
Anticipated
1/01/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
136
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 21691 0
Germany
State/province [1] 21691 0
Niedersachsen

Funding & Sponsors
Funding source category [1] 303326 0
Charities/Societies/Foundations
Name [1] 303326 0
Alexander von Humboldt Foundation
Country [1] 303326 0
Germany
Primary sponsor type
Individual
Name
Dr. J. Matt McCrary
Address
Institute for Music Physiology and Musicians' Medicine
Hannover University of Music, Drama and Media
Neues Haus 1
30175 Hannover
Country
Germany
Secondary sponsor category [1] 303351 0
Individual
Name [1] 303351 0
Prof. Dr. med. Eckart Altenmüller
Address [1] 303351 0
Institute for Music Physiology and Musicians' Medicine Hannover University of Music, Drama and Media Neues Haus 1 30175 Hannover
Country [1] 303351 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303860 0
Central Ethics Committee - Leibniz Universität Hannover
Ethics committee address [1] 303860 0
Ethics committee country [1] 303860 0
Germany
Date submitted for ethics approval [1] 303860 0
02/09/2019
Approval date [1] 303860 0
25/10/2019
Ethics approval number [1] 303860 0
EV LUH 12/2019

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

Contacts
Principal investigator
Name 95050 0
Dr J. Matt McCrary
Address 95050 0
Institute for Music Physiology and Musicians' Medicine Hannover University of Music, Drama and Media Neues Haus 1 30175 Hannover
Country 95050 0
Germany
Phone 95050 0
+491 178 6899834
Fax 95050 0
Email 95050 0
[email protected]
Contact person for public queries
Name 95051 0
J. Matt McCrary
Address 95051 0
Institute for Music Physiology and Musicians' Medicine Hannover University of Music, Drama and Media Neues Haus 1 30175 Hannover
Country 95051 0
Germany
Phone 95051 0
+491 178 6899834
Fax 95051 0
Email 95051 0
[email protected]
Contact person for scientific queries
Name 95052 0
J. Matt McCrary
Address 95052 0
Institute for Music Physiology and Musicians' Medicine Hannover University of Music, Drama and Media Neues Haus 1 30175 Hannover
Country 95052 0
Germany
Phone 95052 0
+491 178 6899834
Fax 95052 0
Email 95052 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Available on request to researchers, journal editors, and systematic reviewers. Responses to other data requests will be determined on a case-by-case basis

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified participant data

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Starting on the publication date of the main study results for a period of ten years.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data can be obtained by contacting the primary investigator ([email protected]) following the publication of main study results

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.