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Trial registered on ANZCTR


Registration number
ACTRN12616000914460
Ethics application status
Approved
Date submitted
27/06/2016
Date registered
8/07/2016
Date last updated
7/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Simulated Military Land Transit on Physical Performance.
Scientific title
The Effects of the Whole Body Vibrational Forces as Experienced during Simulated Military Land Transit on the Physical Performance of Healthy Volunteers
Secondary ID [1] 289556 0
None
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exposure to whole body vibration 298836 0
Condition category
Condition code
Musculoskeletal 298895 298895 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be exposed to one of four exposure conditions lasting 120 minutes. Each condition will take place with the participant seated on a seat taken from a Bushmaster PMV. In order to reproduce the forces experienced during military land transit the seat will be located atop a CKAS 6 degree of freedom simulation platform. This platform will be located within the biomechanics laboratory within the University of South Australia, and has been calibrated to accurately reproduce the recorded forces experienced during military land transit. The whole intervention will be administered by the lead researcher (Thomas Debenedictis) with the groups consisting of:

Negative control group – participants will not be required to be secured to the seat with the use of the seat harness. There will be no vibrational forces

Positive control group – Participants will be secured with the use of the harness attached to the seat for the duration of the exposure. There will be no vibrational forces.

Simulation of a 1st class road group – Participants will be exposed to a period of simulated transit that will represent a 1st class road (paved highway) and be secured to the seat with the use of seat harness

Simulation of a cross country road - participants will be exposed to a period of simulated transit that will represent a cross country conditions and be secured to the seat with the use of seat harness
Intervention code [1] 294802 0
Other interventions
Comparator / control treatment
The control condition will consist of the participants being seated with no harness or whole body vibration forces.

The comparator group will consist of a 16 participants recruited from the currently active Australian Defence Force population
Control group
Active

Outcomes
Primary outcome [1] 298365 0
changes in lower limb strength as measured by the peak landing forces during the drop jump
Timepoint [1] 298365 0
Measures peak landing forces will be taken immediately before the 2 hour land transit simulation and immediately following the simulation as part of the physical performance protocol
Primary outcome [2] 298770 0
Changes in lower limb power as indicated by changes in 20m sprint performance
Timepoint [2] 298770 0
Measures of 20m sprint performance be taken immediately before the 2 hour land transit simulation and immediately following the simulation as part of the physical performance protocol
Primary outcome [3] 298771 0
Changes in full body strength as indicated by changes in Isometric mid-thigh pull strength
Timepoint [3] 298771 0
Measures of full body strength will be taken immediately before the 2 hour land transit simulation and immediately following the simulation as part of the physical performance protocol
Secondary outcome [1] 325149 0
Changes in arm-hand steadiness as indicated by a change in the number of contacts during a arm hand-steadiness test with participants required to hold a 2mm metal stylus attached to the end of a replica rifle in a 4mm hole. A counter will be set up so that each time the metal stylus makes contact with the inside of the hole the circuit is completed and the contact is counted
Timepoint [1] 325149 0
Measures of arm-hand steadiness performance will be completed immediately prior to the military land transit simulation and immediately following the simulation as part of the physical performance protocol
Secondary outcome [2] 325150 0
Changes in lower limb power as indicated by a changes in the rate of force development as measured during the drop jump
Timepoint [2] 325150 0
Changes in the rate of force development during the drop jump will be performed immediately prior to and following the land transit simulation as part of the physical performance protocol
Secondary outcome [3] 325151 0
changes in flexibility as measured during the sit and reach test
Timepoint [3] 325151 0
Measures of flexibility will be performed immediately prior to and following the land transit simulation as part of the physical performance protocol
Secondary outcome [4] 325152 0
Measures of reactive agility will be tested with participants required to react to a light positioned atop two timing gates positioned to form a 'Y' with the 20 m sprint. Upon crossing the end of the 20m sprint the participant will be required to move as fast as possible through the corresponding gate depending on which light activates (left v right)
Timepoint [4] 325152 0
Measures of reactive agility will be performed immediately prior to and following the land transit simulation as part of the physical performance protocol

Eligibility
Key inclusion criteria
Both the general population and Australian Defence Force cohorts will be required to meet the same inclusion criteria allow. Matching both cohorts demographically and in terms of their physiological fitness will allow for comparison between cohorts. All participants will have to meet the following criteria:
Male
Aged 18-24
Injury free within the last 6 months
Able to complete ADF physical performance entry tests
All participants will be required to perform a familiarisation session and the testing protocol.
Minimum age
18 Years
Maximum age
24 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not in the 18-24 age range
Injured during the last 6 months
Unable to complete the ADF physical performance entry test

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)
Central randomisation via email/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In addition to the 60 general population participants that will be recruited for the study, 16 ADF personnel will be recruited as a validation group. These participants will be randomly assigned to either both of the positive or negative control groups or just one, and both the first class and cross country terrain simulations. The decision to randomise this group to only one of the 'control' conditions will be based on the data collected from the 60 general population participants. If analysis indicates that there are no differences in the changes in performance between both the control group then the ADF personnel will only be assigned to the positive control group, first class road simulation and cross country simulation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will use a 2-way (Time [2 levels] and exposure intensity [4 levels]) repeated measures analysis of variance (ANOVA). The assumption of normality of dependent variables will be assessed using a Shapiro-Wilk test; data that is not normally distributed will be transformed for example log-transformed. Where a significant main effect is demonstrated, post-hoc pairwise comparisons will be made using Bonferroni adjustment for multiple comparisons. Significance will be accepted at P<0.05. Data will be reported as mean +/- standard deviation with effect sizes quantified using standardised mean differences and interpreted as small (0.20-0.50), moderate (0.5-0.8) and large (>1.2)]. All statistical analysis will be performed in SPSS (v20, IBM, NY, USA).

In order to assess changes in performance in response to periods of simulated military land transit and based on previously provided effect sizes for each of the performance tests, with a one-sided 5% significance level and 80% power, 12 participants would be required for each exposure group or 48 participants would be required to complete the study. With this in mind and accounting for dropout rates of 15% a total of 60 participants will be recruited with 15 participants assigned to each exposure group.

Due to issues the issues associated with recruiting from the military population the maximum number of participants we have been able to secure for this population is limited to 16 participants. With this in mind, the military population will not be used as part of our primary analysis and will only be used as part of an explorative analysis of the differences in any changes in performance between the general population and military population cohorts in response to the exposure.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/02/2016
Date of last participant enrolment
Anticipated
1/11/2016
Actual
23/01/2017
Date of last data collection
Anticipated
1/11/2016
Actual
30/01/2017
Sample size
Target
76
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 13276 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 293639 0
Government body
Name [1] 293639 0
Defence Science Technology Group
Country [1] 293639 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North terrace
Adelaide
SA 5001
Country
Australia
Secondary sponsor category [1] 292473 0
None
Name [1] 292473 0
Address [1] 292473 0
Country [1] 292473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295076 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [1] 295076 0
Ethics committee country [1] 295076 0
Australia
Date submitted for ethics approval [1] 295076 0
09/09/2015
Approval date [1] 295076 0
07/10/2015
Ethics approval number [1] 295076 0
0000034370

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 885 885 0 0
/AnzctrAttachments/370737-Info sheet 15_10_23.docx

Contacts
Principal investigator
Name 66006 0
Mr Thomas Debenedictis
Address 66006 0
University of South Australia, 101 Currie Street, Adelaide, SA 5001
Country 66006 0
Australia
Phone 66006 0
+61 883 022083
Fax 66006 0
Email 66006 0
[email protected]
Contact person for public queries
Name 66007 0
Thomas Debenedictis
Address 66007 0
University of South Australia, 101 Currie Street, Adelaide, SA 5001
Country 66007 0
Australia
Phone 66007 0
+61 883 022083
Fax 66007 0
Email 66007 0
[email protected]
Contact person for scientific queries
Name 66008 0
Thomas Debenedictis
Address 66008 0
University of South Australia, 101 Currie Street, Adelaide, SA 5001
Country 66008 0
Australia
Phone 66008 0
+61 883 022083
Fax 66008 0
Email 66008 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

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