Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000076471
Ethics application status
Approved
Date submitted
15/01/2007
Date registered
23/01/2007
Date last updated
20/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Combat Agility Program.
Scientific title
A randomised controlled trial of a Neuromuscular Control training program designed to prevent knee and ankle injury in Australian Army Recruits.
Secondary ID [1] 333 0
Australian Defence Human Research Ethics Committee: Protocol 464/06
Universal Trial Number (UTN)
Trial acronym
CAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injury to the knee and/or ankle in healthy Australian Army Recruits. 1568 0
Condition category
Condition code
Musculoskeletal 1669 1669 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is designed to be a rigorous intervention trial (randomised controlled trial) and will be conducted at the Army Recruit Training Centre (ARTC). The intervention will be a specific neuromuscular control (NMC) training program that will target neuromuscular efficiency, biomechanical skills and perceptual awareness.
The NMC training program will consist of the following:
Balance training. Conducted for up to five minutes post warmup and prior to every physical training lesson (approximately 46 lessons during recruit training).
Agility training. Conducted three times a week for up to five minutes. Consists of drills in cutting and turning, jumping and landing, and stopping and propping.

The duration of the trial is from 23 Jan to 10 Aug 07.
Intervention code [1] 1508 0
Prevention
Comparator / control treatment
The Control Group will receive the normal physcial training program delivered to Army recruits at ARTC.
Control group
Active

Outcomes
Primary outcome [1] 2309 0
Incidence of all injury to the knee and/or ankle during the standard 80-day training period.
Timepoint [1] 2309 0
Data regarding individual incidents will be collected weekly. The primary outcomes will be measured at the conclusion of the trial by analysis of data regarding individual incidents recorded throughout the trial period.
Secondary outcome [1] 4034 0
ncidence of ligament injury to the knee and/or ankle during the standard 80-day training period.
Timepoint [1] 4034 0
Measured at the conclusion of the trial by analysis of data regarding individual incidents recorded throughout the trial period.
Secondary outcome [2] 4035 0
Data regarding individual incidents will be collected weekly.
Timepoint [2] 4035 0
Measured at the conclusion of the trial by analysis of data regarding individual incidents recorded throughout the trial period.

Eligibility
Key inclusion criteria
All regular Army recruits enlisting for recruit training in the Australian Army between 23 Jan - 22 May 07 who consent. Army age limits are 17-50 years and generally the proportion of recruits who are female is around 8%.xclusion criteria.
Minimum age
17 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-consent. There are no other exclusion criteria.

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)
Sealed opaque envelopes prepared by someone other than the person informing participants of their allocation and accessed only after participants have consented and been accepted
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Recruits are enlisted into the Army in clusters of approximately 50-100 recruits, each week. Consenting recruits in pairs of recruit clusters will be allocated in their clusters to control and intervention groups using a concealed, blocked (by pairs of clusters), cluster-random allocation procedure based on a published random number table and prepared by someone other than the person allocating clusters to treatment groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The medical staff who record injuries and diagnoses will be blinded to group affiliation.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
830
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1814 0
Government body
Name [1] 1814 0
Army Recruit Training Centre
Country [1] 1814 0
Australia
Primary sponsor type
Government body
Name
Army Recruit Training Centre
Address
Army Recruit Training Centre
Blamey Barracks
Kapooka NSW
Country
Australia
Secondary sponsor category [1] 1636 0
Government body
Name [1] 1636 0
Directorate Occupational Health and Safety - Army
Address [1] 1636 0
Russel Offices Canberra ACT
Country [1] 1636 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3402 0
Army Recruit Training Centre-Australian Defence Human Research Ethics Committee
Ethics committee address [1] 3402 0
Ethics committee country [1] 3402 0
Australia
Date submitted for ethics approval [1] 3402 0
Approval date [1] 3402 0
Ethics approval number [1] 3402 0
464/06

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

Contacts
Principal investigator
Name 27442 0
Address 27442 0
Country 27442 0
Phone 27442 0
Fax 27442 0
Email 27442 0
Contact person for public queries
Name 10697 0
Rod Goodall
Address 10697 0
Headquarters Land Warfare Centre
Canungra QLD 4275
Country 10697 0
Australia
Phone 10697 0
+61 7 55416429
Fax 10697 0
+61 7 55416406
Email 10697 0
[email protected]
Contact person for scientific queries
Name 1625 0
Rod Goodall
Address 1625 0
Headquarters Land Warfare Centre
Canungra QLD 4275
Country 1625 0
Australia
Phone 1625 0
+61 7 55416429
Fax 1625 0
+61 7 55416406
Email 1625 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.