Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001651178
Ethics application status
Approved
Date submitted
21/10/2014
Date registered
26/11/2019
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a neuromuscular training program lead to fewer lower limb injuries in New Zealand Army Recruits?
Scientific title
Does a neuromuscular training program, compared to usual physical training lead to fewer lower limb injuries in New Zealand Army Recruits?
Secondary ID [1] 285149 0
Nil Known
Universal Trial Number (UTN)
Nil known
Trial acronym
Recruit Injury Prevention Research
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb Injury
 292694 0
Condition category
Condition code
Musculoskeletal 293011 293011 0 0
Other muscular and skeletal disorders
Injuries and Accidents 293796 293796 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention training exercises: Light run warm up and a circuit of 14 plus exercises including strength, technique, core stability, motor control and plyometric.
Low to moderate intensity.
Administered by 2 qualified and experienced Army Physical Training Instructors.

Prescription of 3-5 sessions per week for a duration of 6 weeks determined by the existing physical training schedule.

First intake 9th July 2012.
Second intake 6th Aug 2012.
Intervention code [1] 289984 0
Prevention
Comparator / control treatment
Usual physical training exercises: Warm up routinely used by physical training instructors.
Running based and included stretches and strengthening exercises.
Sets, reps and type of exercise varied per session reflecting the task of that day i.e. circuits, pack walk.
Control group
Active

Outcomes
Primary outcome [1] 292869 0
Lower limb injury incidence extracted from medical appointment encounters.

Recruit injury incidence rates: calculated as 1 or more injuries/ total time in company for all recruits x 1000 (injuries/1000 person-days).

Cumulative injury incidence: recruits with 1 or more injuries / all recruits x100.
Timepoint [1] 292869 0
Recorded throughout trial period.
Secondary outcome [1] 309844 0
Number of health care encounters for injury.
Counting number of health care encounters extracted from patient medical records for injuries sustained.
Timepoint [1] 309844 0
Recorded throughout trial period.
Secondary outcome [2] 309845 0
Health care costs
Number of medical encounters and associated costs extracted for injuries sustained.

Timepoint [2] 309845 0
Recorded throughout trial period.
Secondary outcome [3] 311423 0
Lower limb Y Balance Test
Used to measure dynamic stability of the lower limb.
Timepoint [3] 311423 0
Measured week 1, 8 and 15.
Secondary outcome [4] 311424 0
i) Weight-Bearing Dorsi-flexion Lunge Test
Used to measure ankle dorsiflexion range of motion.
Timepoint [4] 311424 0
Measured week 1, 8 and 15.
Secondary outcome [5] 311425 0
Regular Fitness Level, timed 2.4 km. run
Timepoint [5] 311425 0
Measured week 1, 6 and 8 as scheduled by physical training program.
Secondary outcome [6] 311426 0
Light duties time
Time loss (days) due to injury.
Timepoint [6] 311426 0
Recorded throughout trial duration.
Secondary outcome [7] 311427 0
Military Pre-training Questionnaire.
A self reported questionnaire on pre-entry physical fitness, injury history, diet, alcohol and smoking status.
Timepoint [7] 311427 0
Week 1. only.
Secondary outcome [8] 311428 0
Occupational endpoint achievement
The final point a recruit reaches i.e. completed training, backsquaded, voluntary discharge, administrative discharge and medical discharge.
Timepoint [8] 311428 0
Retrospective, post trial.

Eligibility
Key inclusion criteria
Recruit presenting for Army training
Recruit attest to Army training
Consent to study
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Did not consent to study
Did not attest to Army training
Backsquaded recruit re-joining after first physical training session.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Two recruit intakes allocated by Army into two groups per intake.
Cluster randomised into intervention and usual training groups.
Computer randomisation per group by a person unrelated to study.
Result concealed in envelop and handed to head Physical Training Instructor for distribution. to Physical Training Instructors of each study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer randomisation A or B then 1 or 2
One group was intervention, the other usual training.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Double-blinded cluster randomised controlled exercise intervention trial, including economic analysis
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effect of the neuromuscular training program will be examined using one-way ANOVA comparisons of primary and secondary outcome measures between the experimental and control groups. Multiple linear regression analysis will be utilised to determine the influence of biometrics and other participant characteristics on treatment response.

As a direct consequence of working within the constraints of an Army training environment we were required to examine a convenience sample of 2 intakes (8 platoons) compromising approximately 280 soldiers.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/07/2012
Date of last participant enrolment
Anticipated
Actual
6/08/2012
Date of last data collection
Anticipated
Actual
31/12/2012
Sample size
Target
280
Accrual to date
Final
281
Recruitment outside Australia
Country [1] 6286 0
New Zealand
State/province [1] 6286 0

Funding & Sponsors
Funding source category [1] 289740 0
Government body
Name [1] 289740 0
New Zealand Defence Force
Country [1] 289740 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Defence Force
Address
Military Treatment Center
Foley Street
Waiouru Military Camp
Waiouru 4826
Country
New Zealand
Secondary sponsor category [1] 288432 0
University
Name [1] 288432 0
Australian Catholic University
Address [1] 288432 0
School of Allied Health
Australian Catholic University
Brisbane Campus, 1100 Nudgee Road, Banyo, QLD, 4014
PO Box 456 Virginia Queensland, 4014
Country [1] 288432 0
Australia
Other collaborator category [1] 278079 0
Individual
Name [1] 278079 0
Prof. Suzanne Kuys
Address [1] 278079 0
School of Allied Health
Australian Catholic University
Brisbane Campus, 1100 Nudgee Road, Banyo, QLD, 4014
PO Box 456 Virginia Queensland, 4014
Country [1] 278079 0
Australia
Other collaborator category [2] 278234 0
Individual
Name [2] 278234 0
Prof. Belinda Beck
Address [2] 278234 0
Exercise and sport, School of Allied Health Sciences
Gold Coast Campus
Griffith University
Parklands Drive Southport QLD 4222
Country [2] 278234 0
Australia
Other collaborator category [3] 280973 0
Individual
Name [3] 280973 0
Dr Maria Constantinou
Address [3] 280973 0
School of Allied Health
Australian Catholic University
Brisbane Campus, 1100 Nudgee Road, Banyo, QLD, 4014
PO Box 456 Virginia Queensland, 4014
Country [3] 280973 0
Australia
Other collaborator category [4] 280974 0
Individual
Name [4] 280974 0
Mr Mark Brown
Address [4] 280974 0
Clinical Coordinator, Allied Health Clinic
Faculty of Health Sciences
Australia Catholic University
8 Approach Rd Banyo QLD 4014
Country [4] 280974 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291478 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 291478 0
Ethics committee country [1] 291478 0
Australia
Date submitted for ethics approval [1] 291478 0
Approval date [1] 291478 0
22/05/2012
Ethics approval number [1] 291478 0
PES/36/11/HREC

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

Contacts
Principal investigator
Name 50566 0
Ms Narelle Hall
Address 50566 0
C/o
School of Allied Health
Australian Catholic University
Brisbane Campus, 1100 Nudgee Road, Banyo, QLD, 4014
PO Box 456 Virginia Queensland, 4014
Country 50566 0
Australia
Phone 50566 0
+61 7 3623 7655
Fax 50566 0
Email 50566 0
[email protected]
Contact person for public queries
Name 50567 0
Narelle Hall
Address 50567 0
C/o
School of Allied Health
Australian Catholic University
Brisbane Campus, 1100 Nudgee Road, Banyo, QLD, 4014
PO Box 456 Virginia Queensland, 4014
Country 50567 0
Australia
Phone 50567 0
+61 7 3623 7655
Fax 50567 0
Email 50567 0
[email protected]
Contact person for scientific queries
Name 50568 0
Narelle Hall
Address 50568 0
C/o
School of Allied Health
Australian Catholic University
Brisbane Campus, 1100 Nudgee Road, Banyo, QLD, 4014
PO Box 456 Virginia Queensland, 4014
Country 50568 0
Australia
Phone 50568 0
+61 7 3623 7655
Fax 50568 0
Email 50568 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
Military population.


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.