Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000594527
Ethics application status
Approved
Date submitted
1/05/2015
Date registered
5/06/2015
Date last updated
28/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a workplace-based exercise program reduce the risk of neck/shoulder symptoms for dental health students? A pilot study.
Scientific title
Pilot study to evaluate the feasibility and benefits of a 10-week workplace-based exercise intervention to reduce the risks of musculoskeletal disorders of the neck/shoulder in dental health students.
Secondary ID [1] 286594 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Disorders of the Neck/Shoulder 294890 0
Condition category
Condition code
Musculoskeletal 295135 295135 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants are given a workplace-based exercise intervention with 4 resistance strengthening exercises targeting the neck and shoulder muscles. Each exercise is performed for a maximum of 2 minutes a day, for 5 working days a week, for 10 weeks.
The participants are supplied with the resistance bands and an exercise diary each to record their daily performance. 30 minutes of initial exercise training instruction is provided to each participant, with 1 weekly supervised exercise session for the first 4 weeks. Participants will receive weekly reminders to encourage adherence to the exercise program.
Intervention code [1] 291712 0
Prevention
Comparator / control treatment
Cohort Study - nil control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294896 0
Postural Assessment: The Rapid Upper Limb Assessment tool is used to score the risk for developing neck/shoulder pain while the participant is performing a typical oral examination task.
Timepoint [1] 294896 0
Pre and post the 10-week exercise intervention.
Primary outcome [2] 294897 0
Severity of neck/shoulder symptoms with a 11-point visual analogue scale from 0 to 10. A body map is used to define region of neck/shoulder.
Timepoint [2] 294897 0
Pre and post the 10-week exercise intervention.
Secondary outcome [1] 314305 0
Feasibility of the 10-week exercise intervention will be examined via a questionnaire scored on a 5-point Likert scale from 'strongly agree' to 'strongly disagree'. Questions are designed to elicit participants' perception of the intervention such as 'the exercises were easy to perform', 'it was easy to find time to do the exercises'.
Timepoint [1] 314305 0
After the 10-week exercise intervention.
Secondary outcome [2] 314306 0
Adherence to the exercise program, measured with the number of training session completed as recorded in the exercise diary, expressed as a percentage of the 50 possible sessions during the 10 weeks.
Timepoint [2] 314306 0
After the 10-week exercise intervention.
Secondary outcome [3] 314307 0
Exercise Self-Efficacy Scale assessed on a 5-point Likert Scale from 'not at all confident' to 'completely confident'.
Timepoint [3] 314307 0
Pre and post the 10-week exercise intervention.
Secondary outcome [4] 314308 0
Isometric muscle strength testing of the neck flexors and extensors, and shoulder elevators (in scaption plane) with a hand-held dynamometer, using a 'make' test procedure.
Timepoint [4] 314308 0
Pre and post the 10-week exercise intervention.

Eligibility
Key inclusion criteria
Full-time students enrolled in the Bachelor or Oral Health and Bachelor of Dental Science programs at the University of Queensland, and are in their clinical practice years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of cardiovascular or cerebrovascular accident, fibromyalgia, rheumatoid arthritis, cervical disc prolapse, whiplash, and other serious traumatic injury of the neck or shoulder, pregnancy, or if exercise has been contraindicated by their health provider.

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)
This pilot study is a cohort study where all eligible participants will be provided with the same intervention.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2015
Actual
24/04/2015
Date of last participant enrolment
Anticipated
27/04/2015
Actual
27/04/2015
Date of last data collection
Anticipated
1/07/2015
Actual
1/07/2015
Sample size
Target
25
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9605 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 291160 0
Self funded/Unfunded
Name [1] 291160 0
Country [1] 291160 0
Primary sponsor type
University
Name
University Of Queensland
Address
School of Health and Rehabilitation Sciences
Therapies Building 84A
The University of Queensland,
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 290067 0
None
Name [1] 290067 0
Address [1] 290067 0
Country [1] 290067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292736 0
The University of Queensland Institutional Human Research Ethics
Ethics committee address [1] 292736 0
Ethics committee country [1] 292736 0
Australia
Date submitted for ethics approval [1] 292736 0
06/03/2015
Approval date [1] 292736 0
23/04/2015
Ethics approval number [1] 292736 0
2015000346

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

Contacts
Principal investigator
Name 56798 0
Miss Xin Yi Yiu
Address 56798 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
The University of Queensland,
St Lucia QLD 4072
Country 56798 0
Australia
Phone 56798 0
+61 405964040
Fax 56798 0
Email 56798 0
[email protected]
Contact person for public queries
Name 56799 0
Venerina Johnston
Address 56799 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
The University of Queensland,
St Lucia QLD 4072
Country 56799 0
Australia
Phone 56799 0
+61 7 3365 2124
Fax 56799 0
Email 56799 0
[email protected]
Contact person for scientific queries
Name 56800 0
Venerina Johnston
Address 56800 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
The University of Queensland,
St Lucia QLD 4072
Country 56800 0
Australia
Phone 56800 0
+61 7 3365 2124
Fax 56800 0
Email 56800 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.