Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000755134
Ethics application status
Approved
Date submitted
9/05/2019
Date registered
21/05/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
21/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of load and exercise speed on activation pattern of middle trapezius and posterior deltoid muscles in prone fly position.
Scientific title
The Effect of Load and Repetition Velocity on Recruitment Timing of Middle Trapezius and Posterior Deltoid Muscles in Prone Shoulder Horizontal Abduction with External Rotation.
Secondary ID [1] 298197 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder movement dysfunction 312786 0
Condition category
Condition code
Musculoskeletal 311281 311281 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After Maximum Voluntary Isometric Contraction (MVIC) Testing, there should be a five-minute rest for each subject before proceeding. In the starting position, subjects lay prone on the treatment table with neutral shoulders resting in 90° forward flexion (to confirm with goniometer measurements). Prone Horizontal Abduction in External Rotation (PHAER) is performed by extending elbows and horizontally abducting shoulders to a horizontal position, adding external rotation of the shoulder towards the end of the movement.
Subjects will undergo a dynamic warm-up of shoulder movements in all directions within their available range. Skin impedance will be reduced by shaving any hair on the skin and thorough cleaning with an alcohol swab. Proper electrode placement will be confirmed by monitoring EMG signals during specific muscle testing.
First, subjects will complete 3 trials of 5 PHAER exercises (progressive load from 0.5 to 2 kg), with a 2-minute rest between exercises. Repetition velocity will be kept consistent at two seconds concentric to two seconds eccentric using a metronome.
Second, subjects will complete 3 trials of 5 PHAER exercise (progressive velocity from 4 to 0.5 seconds), with a 2-minute rest between exercises.
The study will be administered by the Principal Investigator and Co-Investigators approved by the ethics committee.
The trial is conducted through direct participant engagement.
Each participant is expected to spend 2 hours in the trial and will be remunerated with cash vouchers.
The trial is conducted in the Singapore Institute of Technology and opened to the public. Each participant is involved in 1 session.
Intervention code [1] 314433 0
Rehabilitation
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320026 0
Maximum Voluntary Isometric Contraction of middle trapezius muscle using EMG measurement.
Timepoint [1] 320026 0
Baseline
Secondary outcome [1] 370280 0
Maximum Voluntary Isometric Contraction of posterior deltoid muscle using EMG measurement.
Timepoint [1] 370280 0
Baseline

Eligibility
Key inclusion criteria
- 21 to 30 years of age
- Able to perform PHAER in a pain-free range of motion
- Males with a bodyweight of 50kg to 85kg
- Females with a bodyweight of 50kg to 75kg
Minimum age
21 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of shoulder dislocation or surgery
- Current symptoms related to the cervical spine
- Documented structural injuries to the shoulder complex
- Participation in competitive overhead sports or high-level upper extremity strength training on a regular basis
- On-going orthopaedic follow-up appointment
- Body weight that does not fall within the inclusion criteria

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
First, mean recruitment timings (in milliseconds) and standard deviations will be calculated for each muscle in each exercise. The activation timing of MT relative to PD will be determined by subtracting the mean recruitment time of PD from that of MT. Negative values reflect MT muscle recruitment before PD while positive values reflect MT muscle recruitment after PD. Data will be assessed for normality using the Shapiro-Wilk test on SPSS v25. To investigate the relationship between MT to PD recruitment timing against (1) load and (2) repetition velocity variation, regression modelling of analysis of variance (ANOVA) will be used. Timing differences between the dominant and non-dominant arm will be analysed through a paired t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2019
Actual
26/08/2019
Date of last participant enrolment
Anticipated
16/12/2019
Actual
30/08/2019
Date of last data collection
Anticipated
31/12/2019
Actual
31/08/2019
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 21462 0
Singapore
State/province [1] 21462 0

Funding & Sponsors
Funding source category [1] 302739 0
University
Name [1] 302739 0
Singapore Institute of Technology
Country [1] 302739 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Dr Singapore 138683
Country
Singapore
Secondary sponsor category [1] 302671 0
Commercial sector/Industry
Name [1] 302671 0
Clinical Pilates Family Physiotherapy
Address [1] 302671 0
2 Venture Dr #02-04 Singapore 608526
Country [1] 302671 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303341 0
SIT Institutional Review Board
Ethics committee address [1] 303341 0
Ethics committee country [1] 303341 0
Singapore
Date submitted for ethics approval [1] 303341 0
Approval date [1] 303341 0
08/05/2019
Ethics approval number [1] 303341 0
2019104

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

Contacts
Principal investigator
Name 93338 0
Mr Kwok Boon Chong
Address 93338 0
Clinical Pilates Family Physiotherapy
2 Venture Dr #02-04 Singapore 608526
Country 93338 0
Singapore
Phone 93338 0
+65-69048298
Fax 93338 0
Email 93338 0
[email protected]
Contact person for public queries
Name 93339 0
Kwok Boon Chong
Address 93339 0
Clinical Pilates Family Physiotherapy
2 Venture Dr #02-04 Singapore 608526
Country 93339 0
Singapore
Phone 93339 0
+65-69048298
Fax 93339 0
Email 93339 0
[email protected]
Contact person for scientific queries
Name 93340 0
Kwok Boon Chong
Address 93340 0
Clinical Pilates Family Physiotherapy
2 Venture Dr #02-04 Singapore 608526
Country 93340 0
Singapore
Phone 93340 0
+65-69048298
Fax 93340 0
Email 93340 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
This is to protect the privacy and confidentiality of each participant.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2039Ethical approval    377570-(Uploaded-09-05-2019-12-26-15)-Study-related document.pdf



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.