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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shoulder injuries/ upper extremity injuries

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

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]

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]

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]

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]

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]

Secondary outcome [1]

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]

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

Sex

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

1/08/2018

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]

Saudi Arabia

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Umm Al Qura University

Address [1]

Al Awali, Mecca 24381.

Country [1]

Saudi Arabia

Primary sponsor type

University

Name

Umm Al Qura University

Address

Al Awali, Mecca 24381.

Country

Saudi Arabia

Secondary sponsor category [1]

University

Name [1]

The University of Sydney

Address [1]

75 East Street, Lidcombe, NSW, 2141

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Umm Al Qura University - Research Ethics Committee

Ethics committee address [1]

Al Awali, Mecca 24381.

Ethics committee country [1]

Saudi Arabia

Date submitted for ethics approval [1]

03/04/2018

Approval date [1]

06/06/2018

Ethics approval number [1]

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

A/Prof Wesam Saleh A. Al Attar

Address

Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381

Country

Saudi Arabia

Phone

+966 54 820 6504

Fax

[email protected]

Contact person for public queries

Name

Wesam Saleh A. Al Attar

Address

Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381

Country

Saudi Arabia

Phone

+966 54 820 6504

Fax

[email protected]

Contact person for scientific queries

Name

Wesam Saleh A. Al Attar

Address

Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381

Country

Saudi Arabia

Phone

+966 54 820 6504

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			375309-(Uploaded-01-01-2021-16-52-05)-Basic results summary.docx
Plain language summary	No		During one season, 50 injuries (0.62 injuries/1000... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically