Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000443594
Ethics application status
Approved
Date submitted
20/04/2015
Date registered
8/05/2015
Date last updated
9/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Trunk Muscle Activation on Stable and Unstable Surfaces in healthy Young Adults
Scientific title
Comparison of EMG and Real Time Ultrasound Trunk Muscle Activation on Stable and Unstable Surfaces in Healthy Young Adults
Secondary ID [1] 286562 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor control of trunk muscles 294812 0
Condition category
Condition code
Musculoskeletal 295086 295086 0 0
Normal musculoskeletal and cartilage development and function
Neurological 295087 295087 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undertake three exercises on three surfaces, in varying orders (i.e. this is a crossover study)

1.Lying on plinth on unstable surface (A novel exercise device - the OOV) in three different leg positions held isometrically for 30 seconds (Crook lying, 90 degree hip flexion and straight leg raise position) with 2 minutes rest between efforts.

Five minutes rest between changes in surface.

2. Lying on plinth on unstable surface (foam roller) in three different leg positions held isometrically for 30 seconds (Crook lying, 90 degree hip flexion and straight leg raise position) with 2 minutes rest between efforts.

All interventions will be superivsed by a physiotherapist, exercise scientist or or exercise physiologist
Intervention code [1] 291668 0
Other interventions
Comparator / control treatment
3. Lying on plinth - stable surface in three different leg positions held isometrically for 30 seconds (Crook lying, 90 degree hip flexion and straight leg raise position) with 2 minutes rest between efforts.
Control group
Active

Outcomes
Primary outcome [1] 294848 0
Trunk and hip muscle contraction as assessed by real-time ultrasound of abdominal and hip muscles.
Timepoint [1] 294848 0
Three images will be taken at the end of exhalation during an isometric 30 second hold during each of the three core exercises (rest, hip at 90 degrees flexion and straight leg raise) in each of the three body positions (flat, foam roller and OOV)
Secondary outcome [1] 314194 0
Trunk and hip muscle activation as assessed by electromyography
Timepoint [1] 314194 0
Three separate 3 second data clips (at 5 second intervals) will be captured during an isometric 30 second hold during each of the three core exercises (rest, hip at 90 degrees flexion and straight leg raise) in each of the three body positions (flat, foam roller and OOV)

Eligibility
Key inclusion criteria
Exercise for at least 150 mins/week.
Be able to perform a straight leg raise on a foam roller and OOV for 20 seconds.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lower Back Pain
Neurological Disease
Pregnancy
Musculoskeletal injuries
Obvious kyphosis or scoliosis

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An invitation email has been sent to coaches at a two local sporting clubs to determine interest in running an information session for potential participants. At that session researchers will provide information sheets and describe the study verbally. If potential participants agree to join the study, they will be asked to sign the consent form. Participants will then be allocated a time to attend the UTAS Exercise Physiology Clinic to participate in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be asked to choose a numbered chip from a hat to determine which condition will be trialled first (1=rest, 2=oov, 3=foam roller). This process will be repeated again (minus the first drawn chip) to determine which condition will be trialled second and third.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Between group differences will be analysed using ANOVA with Bonferonni correction (P=0.025)
Sample size is based on previous research examining normative data for real time ultrasound measures of Transverus abdominus ( mean contracted thickness 0.44cm (sd=0.17cm)) with a clinically relevant difference of 30% (0.12 cm) and a reported a power of 90% indicates a sample of 22 people is required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/05/2015
Actual
17/07/2015
Date of last participant enrolment
Anticipated
Actual
23/08/2015
Date of last data collection
Anticipated
Actual
28/08/2015
Sample size
Target
22
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 291124 0
University
Name [1] 291124 0
The University of Tasmania
Country [1] 291124 0
Australia
Primary sponsor type
University
Name
The University of Tasmania
Address
Locked Bag 1322,
Launceston
TAS 7250
Country
Australia
Secondary sponsor category [1] 289799 0
None
Name [1] 289799 0
Address [1] 289799 0
Country [1] 289799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292703 0
Tasmanian Health and Medical Research Ethics Committee
Ethics committee address [1] 292703 0
Ethics committee country [1] 292703 0
Australia
Date submitted for ethics approval [1] 292703 0
Approval date [1] 292703 0
08/04/2015
Ethics approval number [1] 292703 0
H0014758

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

Contacts
Principal investigator
Name 55946 0
Dr Marie-Louise Bird
Address 55946 0
The University of Tasmania
Locked Bag 1322
Launceston, TAS 7250
Country 55946 0
Australia
Phone 55946 0
+61 3 63425497
Fax 55946 0
Email 55946 0
[email protected]
Contact person for public queries
Name 55947 0
Marie-Louise Bird
Address 55947 0
The University of Tasmania
Locked Bag 1322
Launceston, TAS 7250
Country 55947 0
Australia
Phone 55947 0
+61 3 63425497
Fax 55947 0
Email 55947 0
[email protected]
Contact person for scientific queries
Name 55948 0
Marie-Louise Bird
Address 55948 0
The University of Tasmania
Locked Bag 1322
Launceston, TAS 7250
Country 55948 0
Australia
Phone 55948 0
+61 3 63425497
Fax 55948 0
Email 55948 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.