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Trial registered on ANZCTR


Registration number
ACTRN12615001206516
Ethics application status
Approved
Date submitted
2/11/2015
Date registered
5/11/2015
Date last updated
10/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of adding a post-training FIFA 11+ exercise program to the pre-training FIFA11+ injury prevention program in reducing injury rates among amateur Australian soccer players
Scientific title
The effect of adding a post-training FIFA 11+ exercise program to the pre-training FIFA11+ injury prevention program in reducing injury rates among amateur Australian soccer players: A cluster randomized controlled trial.
Secondary ID [1] 287759 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports related injuries 296640 0
Soccer injuries 296641 0
The incidence of initial and recurrent injury and injury severity. 296642 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296871 296871 0 0
Physiotherapy
Injuries and Accidents 296888 296888 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be instructed to perform the ‘11+’ as a warm up for 20 minutes before the training sessions and for 10 minutes warm down after the training sessions 3 times per week, during one season (6 months)
FIFA 11 + program manuals and videos: available to anyone through the 11+ website (http://f-marc.com/11plus/ ).

The FIFA 11+ program, including a total of 15 exercises. It incorporates three main components of exercise regime that include an initial running and active stretching session, followed by a core and leg strength exercise session after which a high speed planting and cutting exercise session is performed. These exercises mainly focus on strengthening the core and leg muscles to improve static, dynamic and reactive neuromuscular control, coordination, balance and agility.
Part 1
Running Exercises - 8 Minutes
1. Running – Straight Ahead
2. Running – Hip Out
3. Running – Hip In
4. Running – Circling Partner
5. Running – Jumping with Shoulder Contact
6. Running – Quick forwards & backwards

Part 2
Strength Plyometric Balance 10 Minutes
7.1. The Bench – Static
7.2. The Bench – Alternate Legs
7.3. The Bench – One Leg Lift & Hold
8.1. Sideways Bench – Static
8.2. Sideways Bench – Raise & Lower Hip
8.3. Sideways Bench – With Leg Lift
9.1. Nordic Hamstring – Beginner
9.2. Nordic Hamstring – Intermediate
9.3. Nordic Hamstring – Advanced
10.1. Single-Leg Stance – Hold the Ball
10.2. Single-Leg Stance – Throwing Ball
10.3. Single-Leg Stance – Test Your Partner
11.1. Squats – With Toe Rise
11.2. Squats – Walking Lunges
11.3. Squats – One-Leg Squats
12.1. Jumping – Vertical Jumps
12.2. Jumping – Lateral Jumps
12.3. Jumping – Box Jumps

Part 3

Running Exercises 2 Minutes
13. Running – Across The Pitch
14. Running – Bounding
15. Running – Plant & Cut

The designated coach for each team will run these sessions.
Record participation of the players in training sessions and matches on weekly basis.
Reporting any injury during training and matches by filling in forms once per week, and send the information on-line by using Sports Injury Tracker, an online sports injury surveillance system developed by Sports Medicine Australia to collect information on the injured players.

Intervention code [1] 293157 0
Prevention
Comparator / control treatment
The control group will practice their usual ‘11+’ warm up.
Control group
Active

Outcomes
Primary outcome [1] 296473 0
Incidence of initial injury. Injury can be recorded if it causes the player to be not able to completely participate in the following match or training session.
Assessed on the number of injuries per 1000 player-hours using Sports Injury Tracker, an online sports injury surveillance system.
Timepoint [1] 296473 0
At the end of the intervention soccer season after randomization.
Primary outcome [2] 296490 0
Incidence of recurrent injury.
Assessed on the number of recurrent injuries per 1000 player-hours using Sports Injury Tracker, an online sports injury surveillance system.
Timepoint [2] 296490 0
At the end of the intervention soccer season.
Primary outcome [3] 296491 0
Injury severity.
Assessed on the number of recurrent injuries per 1000 player-hours using Sports Injury Tracker, an online sports injury surveillance system.
Term Definition

Minimal injury Absence from training and matches for 1–3 days.
Mild injury Absence from training and matches for 4–7 days.
Moderate injury Absence from training and matches for 8–28 days.
Severe injury Absence from training and matches for more than 28 days.
Timepoint [3] 296491 0
At the end of the intervention soccer season.
Secondary outcome [1] 318525 0
A secondary outcome measure is the rate of compliance by review of warm up and cool down participation registers.
Timepoint [1] 318525 0
At the end of the intervention soccer season

Eligibility
Key inclusion criteria
Teams competing at the same level.
Male amateur soccer players.
Training at least three times per week
Minimum age
15 Years
Maximum age
30 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of lower extremity injury requiring medical attention in the past 6 months, or systemic diseases, cardiovascular disease, neurological disorders or bone fractures or surgery in the previous year.
Players who joined a participating team after the start of the trial will be excluded.

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
G*Power: Statistical Power Analyses for Windows Version 3.1.9.2 was used to calculate the sample size of 332 participants. which will be sufficient for this study, 166 in the intervention group, and 166 in the control group. To be able to detect 20 % reduction rate, power of 0.8 and a of 0.05 a sample sizes. That was obtained by using the overall FIFA 11+ risk ratio of 0.654 from Al Atter et al. Meta-Analysis.

The quantitative data will be analyzed using SPSS version 23.0. Descriptive statistics (means and standard deviations) will be used to describe baseline characteristics and exposure data. Intention-to-treat analysis will be used for injury incidence analysis.

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

Funding & Sponsors
Funding source category [1] 292300 0
Self funded/Unfunded
Name [1] 292300 0
Address [1] 292300 0
Country [1] 292300 0
Primary sponsor type
University
Name
THE UNIVERSITY OF SYDNEY
Address
75 East Street, Lidcombe, NSW, 2141
Country
Australia
Secondary sponsor category [1] 290983 0
None
Name [1] 290983 0
Address [1] 290983 0
Country [1] 290983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293776 0
Ethics - The University of Sydney
Ethics committee address [1] 293776 0
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 293776 0
Australia
Date submitted for ethics approval [1] 293776 0
03/12/2015
Approval date [1] 293776 0
04/03/2016
Ethics approval number [1] 293776 0
2015/944

Summary
Brief summary
Background The effects of FIFA 11+ warm-up program for soccer injuries prevention have been evaluated in several studies. However, the importance of a ‘warm down’ using the FIFA 11+ protocol additional to the warm up has not been investigated and yet may be important. Participating in the 11+ in the fatigued state may challenge the athlete and translate directly into real ‘game-like’ conditions.
Objective The main objective of the study is to test whether the intensive FIFA 11+ warm-up combined with warm down program has an additional effect on the incidence, severity of injuries and adherence, compared to the FIFA 11+ warm up alone, among amateur soccer players. .
The ‘11+’ before and after the training sessions is hypothesized to reduce the incidence of injury among male amateur soccer players. The prevention of such injuries will be beneficial to soccer players, clubs, football associations, health insurance companies and society.
Study design Cluster-randomized controlled trial
Methods Male amateur soccer players, aged 18–30 years, will be allocated to interventions or control group. Both groups will perform FIFA 11+ 15 exercises for 20 minutes as a warming up with regular soccer training. The intervention group will additionally perform FIFA 11+ 13 exercises for 10 minutes as a warm-down with every training session. Primary outcome measures are the incidence of initial and recurrent injury and injury severity. A secondary outcome measure is the rate of compliance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61250 0
Prof Ross H. Sanders
Address 61250 0
Discipline of Exercise and Sport Science, Faculty of Health Sciences, the University of Sydney, Lidcombe, NSW 2141 .
Country 61250 0
Australia
Phone 61250 0
+61-2-9351-9067
Fax 61250 0
Email 61250 0
ross.sanders@sydney.edu.au
Contact person for public queries
Name 61251 0
Mr Wesam Saleh A. Al Attar
Address 61251 0
Faculty of Health Sciences, THE UNIVERSITY OF SYDNEY
R016, 75 East Street, Lidcombe, NSW, 2141
Country 61251 0
Australia
Phone 61251 0
+61405043176
Fax 61251 0
Email 61251 0
wala3431@uni.sydney.edu.au
Contact person for scientific queries
Name 61252 0
Mr Wesam Saleh A. Al Attar
Address 61252 0
Faculty of Health Sciences, THE UNIVERSITY OF SYDNEY
R016, 75 East Street, Lidcombe, NSW, 2141
Country 61252 0
Australia
Phone 61252 0
+61405043176
Fax 61252 0
Email 61252 0
wala3431@uni.sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary