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Trial registered on ANZCTR


Registration number
ACTRN12618001118291
Ethics application status
Approved
Date submitted
1/07/2018
Date registered
6/07/2018
Date last updated
6/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Fédération Internationale de Football Association (FIFA ) 11+ Referee' injury prevention program on reducing injury rates among soccer referees and assistant referees.
Scientific title
The effect of the Fédération Internationale de Football Association (FIFA ) 11+ Referee' injury prevention program on reducing injury rates among soccer referees and assistant referees: a randomised controlled trial.
Secondary ID [1] 295371 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports related injuries
 308605 0
Soccer injuries
 308606 0
Condition category
Condition code
Musculoskeletal 307553 307553 0 0
Other muscular and skeletal disorders
Injuries and Accidents 307554 307554 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 FIFA 11+ Referee' injury prevention program during one season (6 months). The program should be performed, as a standard warm-up, at the start of each training session at least twice a week and it takes around 20 minutes to complete. Prior to matches, only the running exercises (parts 1 and 3) should be performed. For all exercises, correct performance is of great importance. Therefore, the coach should supervise the program and correct the referees if necessary.
The FIFA 11+ Referee' injury prevention program manuals available to anyone through the website (https://www.fifamedicinediploma.com/wp-content/uploads/2016/11/fifa_11_referee_manual.pdf).

Part 1: Running Exercises
1 Running Straight Ahead
Jog straight to the last cone. Run slightly more quickly on the way back. Do the exercise twice.
2 Running Circling Partner
Jog forwards to the first cone. Shuffle sideways at a 90-degree angle towards your partner, shuffle an entire circle around one another (without changing the direction in which you are looking) and back to the first cone. Jog to the next cone and repeat the exercise. When you have finished the course, jog back. Do the exercise twice.
3 Running Zigzag Shuffling
Shuffle sideways through the line of cones, alternating the leading leg at each cone, crossing and continuing until the last one. Keep your hips and knees slightly bent. When you have finished the course, jog back. Do the exercise twice.
4 Running Forwards and Backwards Sprints
Run quickly to the second cone then run backwards quickly to the first cone, keeping your hips and knees slightly bent. Repeat, running two cones forwards and one cone backwards. When you have finished the course, jog back. Do the exercise twice.
R-5 Running Slalom Forwards and Backwards
Slalom between the cones whilst jogging forwards until the last cone. When you have finished the course, jog back. Then, slalom between the cones whilst jogging backwards until the last cone. When you have finished the course, jog back.
R-6 Running Forwards and Backwards With Rotations
Jog forwards to the first cone. Decelerate and rotate at a 180-degree angle, continue jogging backwards to the second cone, rotate (in the other direction) and repeat this drill until the last cone. When you have finished the course, jog back. Do the exercise twice.
AR-5 Running Alternate Shuffling
Shuffle sideways, changing the leading leg at each cone, along the line of cones until the last one. When you have finished the course, jog back. Do the exercise twice.
AR-6 Running Cariocas
Shuffle sideways “cariocas” (alternatively crossing legs), with the same leading leg along the line of cones until the last one. when you have finished the course, jog back. Perform the second run by changing the leading leg.
Part 2.1: Strength, Plyometrics and Balance Exercises (for referees: 7 Single-Leg Stance – Move the Other Leg and 8 Front Lunge) (for assistant referees: 7 Lateral Lunge 45° and 8 Lateral Jump).
1 The Bench Alternate Legs
This exercise strengthens your core muscles, which is important to ensure stability of the body in all movements. Assume the starting position by lying on your front, and supporting yourself on your forearms and feet. During this exercise, lift your upper body, pelvis and legs up until your body is in a straight line from head to foot. Draw your shoulder blades in towards your spine so that they lie flat against your back. Your elbows should be directly under your shoulders. Pull in your stomach and gluteal muscles. Lift each leg in turn, holding for a count of 2 seconds. Continue for 30 – 60 seconds. Return to the starting position. Repetitions: 1 set (30 – 60 sec.).
2 Sideways Bench Raise and Lower Hip
This exercise strengthens your lateral core muscles, which is important to ensure stability of the body in all movements. Assume the starting position by lying on your side with both legs straight and supporting yourself on your forearm. During this exercise, raise your pelvis and legs (only the outside of the lower- most foot remains on the floor) until your body forms a straight line from the upper-most shoulder to the upper-most foot. Now lower your hips to the ground and raise them back up again. Repeat for 20 - 30 seconds. The elbow of your supporting arm should be directly under your shoulder. Take a short break, change side and repeat. Repetitions: 1 set (20 – 30 sec. on each side)
3 The Bridge Alternate
This exercise strengthens your back and hip muscles, which is important to ensure stability of the body in all movements. Assume the starting position by lying on your back. Both knees must be flexed at 90°, and both feet should be flat to the ground. During this exercise, lift your pelvis until your body is in a straight line (both feet are on the ground). Pull in your stomach and gluteal muscles. Lift one leg (by extending one knee) off the ground and hold the position for 1 – 2 seconds. Return to the starting position, and lift the other leg. Repeat for 20 – 30 seconds. Repetitions: 1 sets (20 – 30 sec.)
4 Hamstrings Basic
This exercise strengthens your rear thigh muscles. Assume the starting position by kneeling on a soft surface with the knees hip-width apart and crossing your arms across your chest. Your partner should kneel behind you, and with both hands he should grip your lower legs just above the ankles while pushing them with his body weight to the ground. During this exercise, your body should be completely straight from the head to the knees. Slowly lean forwards, trying to hold the position with your hamstrings. When you can no longer hold the position, gently take your weight on your hands, falling into a press-up position. Repetitions: 1 set (7 – 10 repetitions)
5 Calf Basic
This exercise strengthens your calf muscles (and Achilles tendons). Assume the starting position by standing on one leg with the knee extended. During this exercise, stand up on your toes and then slowly lower yourself down (by elevating/lowering vertically your body). Continue for 20 – 30 seconds, and repeat the exercise on the other leg. You may use the support of one stick, or perform the exercise alone while maintaining balance. Repetitions: 1 set (20 – 30 sec. on each side)
6 Double Leg Squat Jumps
This exercise improves your jumping power and movement control. Assume the starting position by standing with your feet hip-width apart and your hands on your hips. During this exercise, slowly bend your hips, knees and ankles until your knees are flexed to 90 degrees. Lean your upper body forwards. Hold this position for 1 second, and then jump as high as you can. While you jump, straighten your whole body. Land softly on the balls of your feet and slowly bend your hips, knees and ankles as much as possible. Repeat for 20 – 30 seconds. Repetitions: 1 set (20 – 30 sec.)
R-7 Single-Leg Stance Move the Other Leg
This exercise improves leg muscle coordination and balance. Assume the starting position by standing on one leg. Bend your knee and hip slightly so that your upper body leans forwards slightly. When viewed from the front, the hip, knee and foot of your supporting leg should be in a straight line. Hold the raised leg slightly behind the supporting leg. During this exercise, hold your balance and perform controlled half-circle movements with the other leg. Hold for 30 seconds, change legs and repeat. Repetitions: 1 set (30 sec. on each side)
R-8 Front Lunges
This exercise strengthens your hamstring and gluteal muscles and improves your movement control. Assume the starting position by standing with both feet hip-width apart on the ground and your hands on your hips. During this exercise, as you lunge, bend your hips and knees slowly until your leading knee is flexed to 90 degrees. The bent knee should not extend beyond the toes. Keep your upper body straight and your pelvis horizontal. Than return to the starting position and lunge forwards with the other leg. Repetitions: 1 set (10 lunges on each side)
AR-7 Lateral Lunges 45°
This exercise strengthens your hip and gluteal muscles and improves your movement control. Assume the starting position by standing with both feet (hip-width apart) on the ground and with your hands on your hips. During this exercise, slowly lunge sideways. As you lunge, bend your hips and knees slowly until your supporting knee is flexed to approximately 45 degrees. Hold the final position for 1 – 2 seconds and then return to the initial position. continue on the other side. Do 10 lunges on each leg. Repetitions: 1 set (10 lunges on each side)
AR-8 Lateral Jumps
This exercise improves your jumping power and movement control on one leg. Assume the starting position by standing on one leg. Bend your hips, knee and ankle slightly and lean your upper body forwards. During this exercise, jump approximately one metre to the side from your supporting leg onto your other leg. Land gently on the ball of your foot and bend your hips, knee and ankle. Hold this position for about a second and then jump onto the other leg. Keep your upper body stable and facing forwards and your pelvis horizontal. Repeat for 20 – 30 seconds. repetitions: 1 set (20 – 30 sec.)
Part 2.2: Strength, Plyometrics and Balance Exercises (for referees: 7 single-leg hops and 8 scissors jumps for assistant referees: 7 lateral lunge 90° and 8 double lateral jumps)
1 The Bench One Leg Lift and Hold
This exercise strengthens your core muscles, which is important to ensure stability of the body in all movements. Assume the starting position by lying on your front, supporting yourself on your forearms and feet. During this exercise, lift your upper body, pelvis and legs up until your body is in a straight line. Draw your shoulder blades in towards your spine so that they lie flat against your back. Your elbows should be directly under your shoulders. Pull in your stomach and gluteal muscles. Lift one leg off the ground and hold the position for 20 – 30 seconds. Return to the starting position, take a short break and repeat the exercise with the other leg. Repetitions: 3 sets (20 – 30 sec. on each side)
2 Sideways Bench With Leg Lift
This exercise strengthens your lateral core muscles, which is important to ensure stability of the body in all movements. Assume the starting position by lying on your side with both legs straight and supporting yourself on your forearm and lower leg. During this exercise, raise your pelvis and legs (only the outside of the lower- most foot remains on the floor) until your body forms a straight line from the upper-most shoulder to the upper-most foot. Now lift your upper-most leg up and slowly lower it down again. Repeat for 20 – 30 seconds. The elbow of your supporting arm should be directly under your shoulder. Take a short break, change sides and repeat. Repetitions: 1 set (20 – 30 sec. on each side)
3 The Bridge on One Leg
This exercise strengthens your back and hip muscles, which is important to ensure stability of the body in all movements. Assume the starting position by lying on your back. Both knees must be flexed at 90°, and both feet should be flat to the ground. During this exercise, lift your pelvis until your body is in a straight line. Pull in your stomach and gluteal muscles. Lift one leg (by extending one knee) off the ground and hold the position for 1 – 2 seconds. Return to the starting position and lift again on the same leg. continue for 20 – 30 seconds. Take a short break, change legs and repeat. Repetitions: 1 sets (20 – 30 sec. on each side)
4 Hamstring Advanced
this exercise strengthens your rear thigh muscles.
Assume the starting position by kneeling on a soft surface with your knees hip-width apart and crossing your arms across your chest. Your partner should kneel behind you, and with both hands he should grip your lower legs just above the ankles while pushing them with his body weight to the ground. During this exercise, your body should be completely straight from the head to the knees. Slowly lean forwards, trying to hold the position with your hamstrings. when you can no longer hold the position, gently take your weight on your hands, falling into a press-up position. repetitions: 1 set (10 – 15 repetitions)
5 Calf Advanced
This exercise strengthens your calf muscles (and Achilles tendons). Assume the starting position on the edge of a board or a box, standing on one leg with the knee extended. During this exercise, stand up on your toes and then slowly lower yourself down (by elevating/lowering your body vertically) below the edge of a board or a box. Continue for 20 – 30 seconds, and repeat the exercise on the other leg. You may use the support of a stick. repetitions: 1 set (20 – 30 sec.)
6 Double Leg Bounding
This exercise improves your jumping power and movement control. Assume the starting position by standing with your feet hip-width apart and your hands on your hips. During this exercise, push off the ground as quickly as you can. While you bound, straighten your whole body. Do not stop when hitting the ground, and continue for 20 – 30 seconds. repetitions: 1 set (20 – 30 sec.)
R-7 Single Leg Cross Hops
This exercise improves body stability through quick movements in different directions. Assume the starting position by standing on one leg, and imagine that there is a cross marked on the ground and you are standing in the middle of it. During this exercise, bend your hip, knee and ankle of your supporting leg. From this position, alternate between jumping forwards and backwards from side to side and diagonally across the cross. Jump as quickly and explosively as possible. Land gently on the balls of your feet and bend your hip, knee and ankle. Lean your upper body forwards slightly throughout the exercise. Continue the exercise for 30 seconds, change legs and repeat. repetitions: 1 set (30 sec. each)
R-8 Scissors Jumps
This exercise improves your jumping power and movement control. Assume the starting position by standing with one leg in front, and the other leg almost extended behind you. Place your hands on your hips. During this exercise, kneel down in a forward lunge, push off the ground and jump as high as you can. Before you land, switch your leg position and repeat the movement. Continue for 20 – 30 seconds. repetitions: 1 set (20 – 30 sec.)
AR-7 Lateral Lunges 90°
This exercise strengthens your hip and gluteal muscles and improves your movement control. Assume the starting position by standing with both feet hip-width apart on the ground and your hands in front of you. During this exercise, slowly lunge sideways. As you lunge, bend your hips and knees slowly until your supporting knee is flexed to 90 degrees. Hold the final position for 1 – 2 seconds, and then return to the initial position. Continue on the other side. Do 10 lunges on each leg. Repetitions: 1 set (10 lunges on each side)
AR-8 Double Lateral Jumps
This exercise improves your jumping power and movement control on one leg. Assume the starting position by standing on one leg. Bend your hips, knee and ankle slightly and lean your upper body forwards. During this exercise, jump approximately one metre to the side from your supporting leg onto your other leg. Land gently on the ball of your foot and bend your hips, knee and ankle. Hold this position for about a second and then jump further laterally on the same leg. Then perform the same double lateral jump in the opposite direction. Keep your upper body stable and facing forwards and your pelvis horizontal. Repeat for 20 – 30 seconds. Repetitions: 1 set (20 – 30 sec.)
Part 3: Running Exercises
1 Running Progression Run
Run approximately 30 metres along the line of cones at 70 – 80% of maximum pace and then jog the rest of the way. Jog back at an easy pace. Do the exercise twice.
2 Running Long Sprints
Sprint across the line of cones at 80 – 90% of maximum pace until the second cone, then slow down, and sprint again until the fifth cone. Then jog the rest of the way. Jog back at an easy pace. Do the exercise twice.
R-3 Running Short Diagonal Sprint
Perform short diagonal runs within the two lines of cones: from the first cone, accelerate to the next opposite cone; when there, decelerate and stop on the foot nearest the outside cone. Repeat the drill to the next opposite cone and so forth. Jog back at an easy pace. Do the exercise twice.
R-4 Running Long Diagonal Sprint
Perform a long diagonal run within the two lines of cones: from the first cone, accelerate to the 2nd last cone of the opposite line and then jog the rest of the way. Jog back at an easy pace.
AR-3 Running Shuffling and Short Sprints
Shuffle sideways to the 2nd cone, and then do a short sprint the 3rd cone, and continue alternating shuffling/sprinting. Jog back at an easy pace. Do the exercise twice.
AR-4 Running Shuffling and Long Sprint
Shuffle sideways along the first 2 cones, and then sprint at 80 – 90% of maximum pace to the last cone, and then slow down progressively. Jog back at an easy pace. Do the exercise twice.
R=Referees; AR=Assistant Referees
Program compliance will be evaluated according to the rate of participation using an attendance log.
Intervention code [1] 301695 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] 306530 0
Incidence of initial 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 [1] 306530 0
At the end of the intervention soccer season.
Primary outcome [2] 306531 0
Incidence of recurrent injury..
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] 306531 0
At the end of the intervention soccer season.
Secondary outcome [1] 348794 0
A secondary outcome measure is the rate of compliance by review of the participation registers.
Timepoint [1] 348794 0
At the end of the intervention soccer season

Eligibility
Key inclusion criteria
Referees
Assistant referees
Soccer
Amateur
Male
Minimum age
25 Years
Maximum age
50 Years
Sex
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.

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
Efficacy
Statistical methods / analysis
G*Power: Statistical Power Analyses for Windows Version 3.1.9.2 was used to calculate the sample size of 100 participants. which will be sufficient for this study, 50 in the intervention group, and 50 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
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10598 0
Saudi Arabia
State/province [1] 10598 0

Funding & Sponsors
Funding source category [1] 299965 0
University
Name [1] 299965 0
Umm Al Qura University
Country [1] 299965 0
Saudi Arabia
Primary sponsor type
University
Name
Umm Al Qura University
Address
Al Awali, Mecca 24381.
Country
Saudi Arabia
Secondary sponsor category [1] 299345 0
University
Name [1] 299345 0
The University of Sydney
Address [1] 299345 0
75 East Street, Lidcombe, NSW, 2141
Country [1] 299345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300827 0
Umm Al Qura University - Research Ethics Committee
Ethics committee address [1] 300827 0
Ethics committee country [1] 300827 0
Saudi Arabia
Date submitted for ethics approval [1] 300827 0
03/04/2018
Approval date [1] 300827 0
06/06/2018
Ethics approval number [1] 300827 0
FAMS11262018

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

Contacts
Principal investigator
Name 84942 0
A/Prof Wesam Saleh A. Al Attar
Address 84942 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84942 0
Saudi Arabia
Phone 84942 0
+966548206504
Fax 84942 0
Email 84942 0
wsattar@uqu.edu.sa
Contact person for public queries
Name 84943 0
Wesam Saleh A. Al Attar
Address 84943 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84943 0
Saudi Arabia
Phone 84943 0
+966548206504
Fax 84943 0
Email 84943 0
wsattar@uqu.edu.sa
Contact person for scientific queries
Name 84944 0
Wesam Saleh A. Al Attar
Address 84944 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84944 0
Saudi Arabia
Phone 84944 0
+966548206504
Fax 84944 0
Email 84944 0
wsattar@uqu.edu.sa

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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No additional documents have been identified.