Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000204842
Ethics application status
Approved
Date submitted
17/02/2012
Date registered
20/02/2012
Date last updated
1/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of an Eight Week Intervention of Exercise and Alexander Technique Specifically Designed for Professional Orchestral Musicians – A National Clinical Trial
Scientific title
Professional Orchestral Musicians undertaking an eight week exercise program compared to an eight week Alexander Technique program and controls.
Secondary ID [1] 279924 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Performance related musculoskeletal disorders 285836 0
Instrumental Playing Posture 285837 0
Condition category
Condition code
Public Health 286017 286017 0 0
Epidemiology
Physical Medicine / Rehabilitation 286018 286018 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
35min exercise class, twice weekly, for eight weeks exercise program specifically designed for professional orchestral musicians. This program consists of 5mins of warm-ups, 25mins of progressive exercises targeting common performance-related musculoskeletal injuries and pain regions (ie. cervical & thoracic spine, shoulder & the upper limb, lumbopelvic region). This program will be supervised by an experienced physiotherapist that has also attained clinical pilates qualifications.

Participants are encouraged to undertake both interventions with a one-month wash out period between the interventions. Participants have the choice of opting out at the end of each intervention. The order of intervention at each of the eight orchestra will be determined using an electronic randomisation system.
Intervention code [1] 284250 0
Prevention
Intervention code [2] 284251 0
Rehabilitation
Comparator / control treatment
Two groups of comparator to the musician specific exercise intervention. A group of participants will undertake Alexander Technique intervention for the same period of time as the Musician Specific Exercise Program (35min classes, twice weekly, for 8 weeks). This program was designed by a qualified Alexander Technique teacher and includes basic skeletal anatomy, postural education from the Alexander principals perspective, movement patterns in activities of daily living and applying principals of Alexander in instrumental playing. Qualified Alexander Technique teachers with additional training to deliver this specific program will be supervising the classes.

A group of controls (no intervention) will be used as well.
Control group
Active

Outcomes
Primary outcome [1] 286513 0
Intensity and Frequency of Performance Related Musculoskeletal Disorders using a 0-10 VAS Scale
Timepoint [1] 286513 0
Post-intervention (8 weeks) and Short Term Follow Up in 6 months.
Primary outcome [2] 286514 0
Perceived exertion of effort during private practice, rehearsals and stage performance using a modified BORG scale (6-20).
Timepoint [2] 286514 0
Post-intervention (8 weeks) and Short Term Follow Up in 6 months.
Secondary outcome [1] 296053 0
Patient Perceived Effort of the Exercise Program & Alexander on posture, ease of movement, ability to cope with anxiety during work and non-work environments, confidence, energy levels, concentration using a 5 point scale.
Timepoint [1] 296053 0
Post-intervention (8 weeks) and Short Term Follow Up in 6 months.
Secondary outcome [2] 296127 0
Independent blinded evaluation of playing posture photographs before and after each trial
Timepoint [2] 296127 0
Photos taken pre-intervention and immediately post-intervention (8 weeks later)

Eligibility
Key inclusion criteria
Full time position with one of the eight orchestras of Australia (Adelaide Symphony, Sydney Symphony, Melbourne Symphony, West Australian Symphony, Tasmanian Symphony, Opera Victoria, Australian Opera and Ballet, Queensland Symphony).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A current major musculoskeletal injury that involves workcover compensation or that was excluded from study participation by a treating medical practitioner.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is not concealed
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Combination of cross-over and single group assignment design as not all participants completed both exercise and Alexander Technique interventions.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
5/07/2010
Date of last participant enrolment
Anticipated
Actual
16/12/2011
Date of last data collection
Anticipated
Actual
31/07/2012
Sample size
Target
150
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 284703 0
Government body
Name [1] 284703 0
Australian Research Council
Country [1] 284703 0
Australia
Funding source category [2] 284704 0
Commercial sector/Industry
Name [2] 284704 0
Australia Council of the Arts
Country [2] 284704 0
Australia
Primary sponsor type
Individual
Name
Dr Bronwen Ackermann
Address
Discipline of Biomedical Science, Room L115, Building C42, Cumberland Campus, The University of Sydney, 75 East St, Lidcombe, NSW 2141.
Country
Australia
Secondary sponsor category [1] 283604 0
Individual
Name [1] 283604 0
A/Prof Tim Driscoll
Address [1] 283604 0
Edward Ford Building, School of Public Health, Camperdown Campus, The University of Sydney, NSW 2005.
Country [1] 283604 0
Australia
Other collaborator category [1] 260541 0
Individual
Name [1] 260541 0
Mr Cliffton Chan
Address [1] 260541 0
Discipline of Biomedical Science, Building C42, Cumberland Campus, The University of Sydney, 75 East St, Lidcombe, NSW 2141.
Country [1] 260541 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286711 0
Human Research Ethics Committee
Ethics committee address [1] 286711 0
Ethics committee country [1] 286711 0
Australia
Date submitted for ethics approval [1] 286711 0
Approval date [1] 286711 0
19/04/2010
Ethics approval number [1] 286711 0
12523

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

Contacts
Principal investigator
Name 33766 0
Dr Cliffton Chan
Address 33766 0
Discipline of Biomedical Science, School of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, 75 East St, Lidcombe, NSW, 2141
Country 33766 0
Australia
Phone 33766 0
+61293519244
Fax 33766 0
Email 33766 0
[email protected]
Contact person for public queries
Name 17013 0
Dr Bronwen Ackermann
Address 17013 0
Discipline of Biomedical Science, Room L115, Building C42, Cumberland Campus, The University of Sydney, 75 East St, Lidcombe, NSW 2141.
Country 17013 0
Australia
Phone 17013 0
+61 2 9351 9472
Fax 17013 0
Email 17013 0
[email protected]
Contact person for scientific queries
Name 7941 0
Dr Bronwen Ackermann
Address 7941 0
Discipline of Biomedical Science, Room L115, Building C42, Cumberland Campus, The University of Sydney, 75 East St, Lidcombe, NSW 2141.
Country 7941 0
Australia
Phone 7941 0
+61 2 9351 9472
Fax 7941 0
Email 7941 0
[email protected]

No information has been provided regarding IPD availability


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.