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Trial registered on ANZCTR


Registration number
ACTRN12618001080213
Ethics application status
Approved
Date submitted
14/06/2018
Date registered
28/06/2018
Date last updated
28/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Fédération Internationale de Football Association (FIFA ) 11+ shoulder injury prevention program on reducing the incidence of upper extremity injuries among soccer goalkeepers.
Scientific title
The effect of the FIFA 11+ shoulder injury prevention program on reducing the incidence of upper extremity injuries among soccer goalkeepers: a randomised controlled trial.
Secondary ID [1] 295157 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder injuries/ upper extremity injuries 308268 0
Condition category
Condition code
Injuries and Accidents 307282 307282 0 0
Other injuries and accidents
Musculoskeletal 307464 307464 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be instructed to perform the FIFA 11+ shoulder injury prevention program (FIFA 11+S) during one season (6 months). Group sessions will be administered by an exercise physiologist and/ or athletic trainer and/ or soccer coaches and/ or strength and conditioning specialists and/ or physiotherapist.. The program consists of three parts: general warming-up exercises (part I), exercises to develop strength and balance of the shoulder, elbow, wrist, and finger muscles (part II), and advanced exercises for core stability and muscle control (part III). The FIFA 11+S takes ~20–25 minutes to complete and replaces the usual warm-up before training.
All exercises focus on core stability, neuromuscular control, eccentric rotator strength, and agility.

Part I – Warm-up exercises (should be performed for 7 minutes.)
1 Run
Relaxed walking or running.
The speed can be progressively increased. 5 min
2 Throw the ball in the chest line
Ask for help from a partner.
With both hands in front of the body, throw and catch the ball, first with your elbows flexed and then with your arms over your head. 1 min
3 Spinning movements with the hands
Interlace the fingers and make spinning movements with the hands. 1 min.
Part II – strength and balance of the shoulder, elbow, wrist, and finger muscles (should be performed in 9–10 minutes at 3 sets of 15 repetitions). Exercises should be changed according to the tolerance of the athlete (to A for B and C exercises)
1A External rotation
Initial position: Standing with the elbow flexed at 90° to the side Exercise: Rotate the arm from neutral to external rotation.
1B External rotation
Initial position: standing with the elbow flexed at 90° and 45° abducted
Exercise: Rotate the arm from the neutral to external rotation.
1C External rotation
Initial position: standing with the elbow flexed at 90° and 90° abducted
Exercise: Rotate the arm from the neutral to external rotation.
2A Internal rotation
Initial position: standing with the elbow flexed at 90° to the side
Exercise: Rotate the arm from neutral to external rotation.
2B Internal rotation
Initial position: standing with the elbow flexed at 90° and 45° abducted
Exercise: Rotate the arm from neutral to internal rotation.
2C Internal rotation
Initial position: standing with the elbow flexed at 90° and 90° abducted
Exercise: Rotate the arm from neutral to internal rotation.
3A Scaption
Rise the arm with external rotation in the scapular plane (30° in the frontal plane) to shoulder height. Hold a weight.
3B Scaption
Rise the arm with external rotation in the scapular plane (30° in the frontal plane) to shoulder height. Hold heavier weight than the previous level.
3C Scaption
Rise the arm with external rotation in the scapular plane (30° in the frontal plane) to shoulder height. Hold heavier weight than the previous level.
4A Push-up-plus
In the prone position.
The hands should be placed at a distance corresponding to the width of the shoulders.
Exercise: Rise the body and then lower the body
4B Push-up-plus
In the same position.
Place an anklet of 5 kg on your back.
Exercise: Rise the body and then lower the body.
4C Push-up-plus
In the same position but on one foot.
Place an anklet of more than 5 kg on your back.
Exercise: Rise the body and then lower the body.
5A Inferior and mid trapezius
In the prone position, arms in 90° abduction.
After changing the arms to 120° of abduction.
Exercise: Hold a weight and bring the arm back slightly.
5B Inferior and mid trapezius
In the prone position, arms In 90° abduction.
After changing the arms to 120° of abduction.
Exercise: Hold heavier weight than the previous level and bring the arm back slightly.
5C Inferior and mid trapezius
In the prone position, arms in 90° abduction. After changing the arms to 120° of abduction.
Exercise: Hold heavier weight than the previous level and bring the arm back slightly.
6A Biceps
Position: Arms at your sides, palms facing inwards. Hold a weight.
Exercise: Bend your elbows, turning the palms upward.
6B Biceps
Position: Arms at your sides, palms facing inwards. Hold heavier weight than the previous level.
Exercise: Bend your elbows, turning the palms upward.
6C Biceps
Position: Arms at your sides, palms facing inwards. Hold heavier weight than the previous level.
Exercise: Bend your elbows, turning the palms upward.
7A Wrist flexors
Position: Support the forearm, palm of the hand upward. Hold a weight.
Exercise: Lower the weight as far as possible and then lift it up.
7B Wrist flexors
Position: Support the forearm, palm of the hand upward. Hold heavier weight than the previous level.
Exercise: Lower the weight as far as possible and then lift it up.
7C Wrist flexors
Position: Support the forearm, palm of the hand upward.Hold heavier weight than the previous level.
Exercise: Lower the weight as far as possible and then lift it up.
8A Wrist extensors
Position: Support the forearm, palm of the hand down. Hold a weight.
Exercise: Lift up weight as far as possible and then lift it up.
8B Wrist extensors
Position: Support the forearm, palm of the hand down. Hold heavier weight than the previous level.
Exercise: Lift up weight as far as possible and then lift it up.
8C Wrist extensors
Position: Support the forearm, palm of the hand down. Hold heavier weight than the previous level.
Exercise: Lift up weight as far as possible and then lift it up.
9A Finger flexors
Position: Supported forearm and palm of the hand down on an elastic.
Exercise: Close the hand, pulling the elastic.
9B Finger flexors
Position: Supported forearm and palm of the hand down on an elastic. Increase the resistance of the elastic.
Exercise: Close the hand, pulling the elastic.
9C Finger flexors
Position: Supported forearm and palm of the hand down on an elastic. Increase the resistance of the elastic.
Exercise: Close the hand, pulling the elastic.
10A Finger extensors
Position: Supported forearm and palm of the hand upward on an elastic. The other hand holds the elastic.
Exercise: Open the hand, stretching the elastic.
10B Finger extensors
Position: Supported forearm and palm of the hand upward on an elastic. The other hand holds the elastic. Increase the resistance of the elastic.
Exercise: Open the hand, stretching the elastic.
10C Finger extensors
Position: Supported forearm and palm of the hand upward on an elastic. The other hand holds the elastic. Increase the resistance of the elastic.
Exercise: Open the hand, stretching the elastic.
Part III – Core stability and muscle control with advanced exercises (the athlete must do the exercises at high velocities with 5 or 6 sets of 15 to 20 repetitions, not exceeding 9–10 minutes.)
1 Jump and throw the ball over the head
Ask for help from a partner. Jump and with the elbow extended and arm above the level of the head, throw and catch the ball.
2 Throw the ball over the head with an arm
Ask for help from a partner. With the elbow extended and arm above the level of the head, throw and catch the ball with an arm.
3 Throw the ball to the sides
With the elbow extended, throw and catch the ball one arm at a time. Make the movement with the arm by the body’s side and lift it up over the head.
4 Jump with your hands on the mini trampoline
In prone position, firming yourself with the feet on the ground and the palms of the hands on the mini trampoline. “jump” with your hands, keeping the elbows straight.
5 Walking on hands
Ask for a partner to hold your legs and, in prone position, “walk” using your hands. Move forward, backward and to the sides.
6 Plyometric external rotation
Flexed elbow in 90° and flexed and abducted arm in 90°. Hold the elastic and make movements from neutral to lateral rotation quickly.

These exercises should be performed three times per week and should be added to the training taken by the soccer goalkeeper. Part I exercises should be done for 7 minutes as a general warm-up. Part II exercises should be performed for 9–10 minutes in a low-resistance (light tubing strength or 2–3 kg), high-repetition format (three sets of 15–20 repetitions), in order to improve strength and local muscular endurance.
Exercise should be changed according to the tolerance of the athlete (to A instead of B and C exercises). In part III, the athlete must do the exercises at high velocities with five or six sets of 15–20 repetitions not exceeding 9–10 minutes; these exercises are performed to increase local muscular endurance.

Program compliance will be evaluated according to the players’ rate of participation using an attendance log. The investigator will randomly visit one team selected from each group each week throughout the study period to motivate the teams and to ensure that the program is being followed conscientiously and correctly.
Intervention code [1] 301496 0
Prevention
Comparator / control treatment
The control group will practice their usual warm up.
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
Control group
Active

Outcomes
Primary outcome [1] 306237 0
Incidence of initial shoulder /upper extremity injuries.
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.
Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia).
Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.
Timepoint [1] 306237 0
At the end of the intervention soccer season.
A General Estimating Equation (GEE) with an intention-to-treat (ITT) analysis will be performed to compare the effect of the interventions on the number of incidence of initial injuries incurred for each player.
Primary outcome [2] 306238 0
Incidence of recurrent shoulder /upper extremity injuries.
Recurrent injury is defined as a repeat episode of a fully recovered injury.
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.
Coaches in both the experimental and control groups will be reporting injuries during training and matches by filling in forms once per week and submitting the information using the Sports Injury Tracker injury reporting form (Sports Medicine Australia).
Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training. Exposure time in hours will be calculated for each team over a 6-month period.
Timepoint [2] 306238 0
At the end of the intervention soccer season.
A General Estimating Equation (GEE) with an intention-to-treat (ITT) analysis will be performed to compare the effect of the interventions on the number of incidence of recurrent injuries incurred for each player.
Secondary outcome [1] 347940 0
Injury severity is defined as time loss in days (days unable to train): minor (1 to 7 days lost), moderate (8 to 21 days lost), or severe (>21 days lost). Injury severity data will be collected from Sports Injury Tracker injury reporting form.
Timepoint [1] 347940 0
At time of any injury occurring throughout intervention soccer season.
A GEE cumulative logistic regression with ITT analysis will be used for injury severity analysis.

Eligibility
Key inclusion criteria
Soccer teams
Amateur.
Male .
Goalkeepers
Training at least three times per week.
Minimum age
14 Years
Maximum age
40 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of upper 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 52 participants. which will be sufficient for this study, 26 in the intervention group, and 26 in the control group.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 10543 0
Saudi Arabia
State/province [1] 10543 0

Funding & Sponsors
Funding source category [1] 299747 0
University
Name [1] 299747 0
Umm Al Qura University
Address [1] 299747 0
Al Awali, Mecca 24381.
Country [1] 299747 0
Saudi Arabia
Primary sponsor type
University
Name
Umm Al Qura University
Address
Al Awali, Mecca 24381.
Country
Saudi Arabia
Secondary sponsor category [1] 299087 0
University
Name [1] 299087 0
The University of Sydney
Address [1] 299087 0
75 East Street, Lidcombe, NSW, 2141
Country [1] 299087 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300637 0
Umm Al Qura University - Research Ethics Committee
Ethics committee address [1] 300637 0
Al Awali, Mecca 24381.
Ethics committee country [1] 300637 0
Saudi Arabia
Date submitted for ethics approval [1] 300637 0
03/04/2018
Approval date [1] 300637 0
06/06/2018
Ethics approval number [1] 300637 0
FAMS11062018

Summary
Brief summary
The FIFA 11+ shoulder program is structured into three parts: general warming-up exercises to improve strength and balance of the shoulder, elbow, wrist, and finger muscles, and advanced exercises for core stability and muscle control. The purpose of this study is to evaluate the effect of the FIFA 11+ shoulder injury prevention program on reducing the incidence of upper extremity injuries among soccer goalkeepers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84294 0
A/Prof Wesam Saleh A. Al Attar
Address 84294 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84294 0
Saudi Arabia
Phone 84294 0
+966 54 820 6504
Fax 84294 0
Email 84294 0
wsattar@uqu.edu.sa
Contact person for public queries
Name 84295 0
A/Prof Wesam Saleh A. Al Attar
Address 84295 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84295 0
Saudi Arabia
Phone 84295 0
+966 54 820 6504
Fax 84295 0
Email 84295 0
wsattar@uqu.edu.sa
Contact person for scientific queries
Name 84296 0
A/Prof Wesam Saleh A. Al Attar
Address 84296 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84296 0
Saudi Arabia
Phone 84296 0
+966 54 820 6504
Fax 84296 0
Email 84296 0
wsattar@uqu.edu.sa

No information has been provided regarding IPD availability
Summary results
No Results