Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001117202
Ethics application status
Approved
Date submitted
30/06/2018
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+ Kids injury prevention program on reducing injury rates in children’s soccer.
Scientific title
The effect of the Fédération Internationale de Football Association (FIFA ) 11+ Kids injury prevention program on reducing injury rates in children’s soccer: a cluster-randomised trial.
Secondary ID [1] 295163 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soccer Injuries 308279 0
Condition category
Condition code
Injuries and Accidents 307290 307290 0 0
Other injuries and accidents
Musculoskeletal 307552 307552 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 “11+ Kids” injury prevention program during one season (6 months) at least twice a week. ‘11+ Kids’ consists of seven different exercises and can be performed in about 15–20 min.
Three exercises focus on unilateral, dynamic stability of the lower extremities (hopping, jumping and landing), three exercises on whole body and trunk strength/stability, and one exercise on falling technique. The difficulty of each exercise is progressively increased in five levels to account for the varying age- and maturity-related performance levels, as well as for general differences in motor skills of children aged 7–13 years.
EXERCISE 1: “ALERTNESS” RUNNING GAME
LEVEL 1: LISTEN FOR THE STOP COMMAND LISTEN TO THE COACH
3 SETS WITH 5 STOP COMMANDS PER SET
STARTING POSITION: the players stand on the goal line, about 2 metres apart. The coach stands just outside the penalty area (distance depends on the players’ age).
ACTION: at the coach’s command, the players run straight ahead towards the coach. If the coach calls “right” or “left”, the players must stand on the right or left leg and maintain their balance for around 3 seconds. They can hop until they find their balance. The knee of the supporting leg should not be fully extended, and the arms can be used for balance. If the player does not stand on one leg at the stop command or the other foot touches the ground within 3 seconds, he/she must jog back to the goal line. The coach then gives the command to run and stop (five times in total per set). All players then jog back to the goal line.
LEVEL 2: WATCH FOR THE STOP COMMAND
STARTING POSITION AND ACTION: as level 1, except that the players watch the coach for the stop command. The coach indicates the leg on which they should stop.
WATCH THE COACH 3 SETS WITH 5 STOP COMMANDS PER SET
LEVEL 3: BALL IN THE HANDS AND LISTEN FOR THE STOP COMMAND
STARTING POSITION AND ACTION: as level 1, except that the players hold a ball with both hands.
LISTEN TO THE COACH 3 SETS WITH 5 STOP COMMANDS PER SET
LEVEL 4: BALL IN THE HANDS AND WATCH FOR THE STOP COMMAND
STARTING POSITION AND ACTION: as level 2, except that the players hold a ball with both hands.
WATCH THE COACH 3 SETS WITH 5 STOP COMMANDS PER SET
LEVEL 5: DRIBBLE WITH THE BALL AND LISTEN FOR THE STOP COMMAND
STARTING POSITION AND ACTION: as level 1, except that the players dribble with the ball. At the stop command, the players stop the ball with the foot and stand on one leg without touching the ball with the free foot.
LISTEN TO THE COACH 3 SETS WITH 5 STOP COMMANDS PER SET
EXERCISE 2: SKATING JUMPS
LEVEL 1: LEARNING HOW TO LAND
STARTING POSITION: the players stand on the goal line, about 2 metres apart. The coach tells the players which leg to stand on and makes sure that every player is standing on the correct leg.
ACTION: at the coach’s command (“jump!”), the players jump forward on one leg and land on the other leg. The coach indicates the direction in order to avoid collisions.
Example: when jumping from the left foot, the player should jump forwards to the right, finding their balance on landing and standing on one leg for 3 seconds. While balancing, the knee of the supporting leg is slightly bent. Balancing with the arms is permitted. The coach then gives the command for the next jump in the other direction. The player should make a clear sideways movement with each jump in order to move forwards in a zigzag. After 5 jumps on each leg, the player returns slowly to the goal line.
LISTEN TO THE COACH 2 SETS OF 10 JUMPS (5 PER LEG)
LEVEL 2: BALL IN BOTH HANDS
STARTING POSITION AND ACTION: as level 1, except that the players hold a ball with both hands.
LISTEN TO THE COACH 2 SETS OF 10 JUMPS (5 PER LEG)
LEVEL 3: BALANCING WITH THE BALL IN ONE HAND
STARTING POSITION AND ACTION: as level 1, except that the players balance with the ball on an outstretched hand (one set with the right hand and one with the left).
LISTEN TO THE COACH 2 SETS OF 10 JUMPS (5 PER LEG)
LEVEL 4: DROPPING THE BALL ONTO THE GROUND
STARTING POSITION AND ACTION: as level 2, except that on landing, the players stretch while standing on one leg and, with the ball above their heads, bend over forwards, drop the ball gently onto the ground and then assume the upright position again. This should be done slowly and in a controlled manner.
LISTEN TO THE COACH 2 SETS OF 10 JUMPS (5 PER LEG)
LEVEL 5: DYNAMIC BALANCING WITH BALL
STARTING POSITION AND ACTION: as level 4, except that the players stretch their free leg behind them upwards and both arms forwards and then return to the usual one-leg position. This is followed by the next jump. The players make as long a stretch as possible, the idea being for the ball, head, torso and raised leg to be in one straight line.
LISTEN TO THE COACH 2 SETS OF 10 JUMPS (5 PER LEG)
EXERCISE 3: SINGLE-LEG STANCE
LEVEL 1: THROWING THE BALL
STARTING POSITION: 2 players stand on one leg at 3-5 metres opposite each other.
ACTION: the players take it in turns to throw a ball to each other. The distance between them should be reduced to begin with and a simple throwing technique used.
1 SET ON EACH LEG 5 THROWS PER PLAYER
LEVEL 2: THROWING THE BALL AND MOVING IT AROUND THE FREE LEG
STARTING POSITION AND ACTION: as level 1, except that after it the ball is thrown, the player moves it around the raised free leg.
1 SET ON EACH LEG 5 THROWS PER PLAYER
LEVEL 3: PASSING GAME
STARTING POSITION: 2 players stand on one leg at 2-5 metres opposite each other.
ACTION: the players pass the ball to each other along the ground with the instep, stopping the ball before returning the pass. Passes should be as accurate as possible so that the players can stay in position.
1 SET ON EACH LEG 5 PASSES PER PLAYER
LEVEL 4: THROWING THE BALL AND PASSING BACK WITHOUT TOUCHING THE GROUND STARTING POSITION: as level 3. ACTION: the player throws the ball to their partner so that the latter can pass back with the foot. The pass should be volleyed (i.e. without the ball touching the ground first) and be played as accurately as possible so that the player who threw the ball can catch it. The partner must also throw the ball accurately for the volleyed pass to be accurate. Hopping is permitted to find balance.
1 SET ON EACH LEG 5 THROWS PER PLAYER
LEVEL 5: TESTING THE PARTNER’S BALANCE
STARTING POSITION: two players stand on one leg opposite each other, within arm’s reach. Both hold a ball in both hands in front of each other.
ACTION: they push the balls against each other at chest height and try to push each other off balance. When one player touches the ground with the raised foot, the game begins again. The players can hop to regain balance. No hitting movements should be made: the balls must always be touching each other. The coach chooses the exercise partners according to size and dexterity. The exercise can be turned into a competition by awarding a point to the player who sends their partner off balance.
1 SET ON EACH LEG FOR 20 SECONDS EACH
EXERCISE 4: PRESS-UPS
LEVEL 1: TUNNEL
STARTING POSITION: one player stands while the other players are in press-up position close to each other to form a tunnel, hands and feet hip-width apart.
ACTION: The standing player rolls a ball down the tunnel and then goes to the start of the tunnel and assumes the press-up position. After the ball has rolled through, the last player in the tunnel takes it and runs to the start of the tunnel, rolls the ball through and goes to the start of the tunnel in the press-up position. The tunnel meanders on in this way. The exercise can be turned into a competition between two groups.
2 SETS, WITH EACH CHILD ROLLING THE BALL ONCE (MAXIMUM 8 PLAYERS PER GROUP)
LEVEL 2: FOREARM SUPPORT; SHIN RESTING ON BALL STARTING POSITION:
The players lie with their forearms flat on the ground and the ball under the middle of their shins, head facing the ground. The body should be in a straight line from head to foot.
ACTION: the players move themselves forward until the ball lightly touches the feet and then back until the ball is almost under the knees. The movements should be slow and deliberate. The forearms stay in the same place and the legs should always be on the ball.
3 SETS OF 15 SECONDS EACH
LEVEL 3: ROLLING THE BALL AROUND THE HANDS
STARTING POSITION: the players are in the press-up position, with a ball in front of each player.
ACTION: the players lift a hand from the ground and roll the ball around the other hand that is still on the ground. They then swap hands to repeat the exercise, thus making a figure eight with the ball.
3 SETS OF 15 SECONDS EACH
LEVEL 4: ROLLING THE BALL BETWEEN HANDS AND FEET
STARTING POSITION: as level 3.
ACTION: the players roll the ball with the left hand under the body to the left foot and then pass the ball with the same foot to the right hand. Repeat the exercise starting with the right hand (to the right foot and then up to the left hand), thus switching sides.
3 SETS OF 15 SECONDS EACH
LEVEL 5: HANDS ON THE BALL
STARTING POSITION: as level 3, except that the players support themselves by placing both hands on the ball.
ACTION: the players move slowly backwards with the feet in small stages and then back to the starting position.
The movements must be made calmly and in a controlled manner. Note: if the grass is damp, switch to level 4.
3 SETS OF 10 SECONDS EACH
EXERCISE 5: SINGLE-LEG JUMPS
LEVEL 1: FORWARDS
STARTING POSITION: the players stand on one leg on the goal line with clear space between them, i.e. about 2 metres apart.
ACTION: at the coach’s command, the players jump forward on one leg, landing on the same leg. The jumps should be as long as possible. Players should stand still for around 3 seconds after landing. After a complete set (10 jumps in total), the players walk slowly back to the goal line.
LISTEN TO THE COACH 2 SETS OF 5 JUMPS ON ONE LEG AND 5 ON THE OTHER
LEVEL 2: BACK AND FORTH
STARTING POSITION: the players stand on one leg about 2 metres in front of the goal line with clear space between them, i.e. about 2 metres apart.
ACTION: as level 1, except that the coach indicates whether to jump forwards or backwards.
WATCH THE COACH 2 SETS OF 5 JUMPS ON ONE LEG AND 5 ON THE OTHER
LEVEL 3: SIDEWAYS
STARTING POSITION AND ACTION: as level 2, except that the players jump sideways. The coach indicates the direction, and constantly watches to ensure that no collisions occur due to players being too close to each other.
LISTEN TO THE COACH 2 SETS OF 5 JUMPS ON ONE LEG AND 5 ON THE OTHER
LEVEL 4: THE COACH INDICATES THE DIRECTION
STARTING POSITION AND ACTION: as level 2, except that the players jump in the direction indicated by the coach (forwards, backwards, left and right). The coach gives the command (“Jump!”) while indicating the direction, to avoid collisions. Ensure that there is sufficient space between the players!
LISTEN TO THE COACH 2 SETS OF 5 JUMPS ON ONE LEG AND 5 ON THE OTHER
LEVEL 5: THE COACH INDICATES THE DIRECTION; BALL IN BOTH HANDS
STARTING POSITION AND ACTION: as level 4, except that the players hold a ball in both hands.
LISTEN TO THE COACH 2 SETS OF 5 JUMPS ON ONE LEG AND 5 ON THE OTHER
EXERCISE 6: SPIDERMAN
LEVEL 1: STROKING THE BALL
STARTING POSITION: the players support themselves on their hands and feet, hip-width apart, the back pointing towards the ground. The body should be in as straight a line as possible from the head to the knees. The ball is directly in front of the feet.
ACTION: the players lift one leg, touch the ball with one foot and roll it gently forwards and then backwards. They repeat the exercise with the other leg and then alternate the movement with each leg. The movement should be slow and deliberate.
3 SETS OF 15 SECONDS EACH
LEVEL 2: A PROPER STRETCH
STARTING POSITION: as level 1.
ACTION: the players move backwards with their hands extended and then return to the starting position and then move with their feet forwards until the body is fully stretched and back again. The players perform the exercise slowly and in a controlled manner, alternating the movements.
3 SETS OF 15 SECONDS EACH
LEVEL 3: THE CRAB STARTING POSITION: as level 1.
ACTION: the players move forward on all fours (feet at the front) towards the coach.
3 SETS (5-10 METRES, DEPENDING ON ABILITY)
LEVEL 4: DRIBBLING
STARTING POSITION AND ACTION: as level 3, except that the players “dribble” with a ball, which is guided in a controlled manner.
3 SETS (5-10 METRES, DEPENDING ON ABILITY)
LEVEL 5: BALL BEARING
STARTING POSITION: as level 1, except that the players support themselves by placing their feet on the ball.
ACTION: the players roll the ball under their feet and move forwards slowly and in a controlled manner.
3 SETS (3-7 METRES, DEPENDING ON ABILITY)
EXERCISE 7: SIDEWAYS ROLL
LEVEL 1: SQUATTING POSITION
STARTING POSITION: the players squat, about 2 metres apart.
ACTION: the players put both hands on the ground in front of their knees. They then lower their heads so that the chin is nearly touching the chest and roll over diagonally on their arm, shoulder and back. Example: if rolling to the right, the right arm should be bent and in front of the body. The players then roll over on the outside of their right arm and right shoulder and then diagonally over their back onto their feet. After every roll, the coach must wait for at least 5 seconds before giving the next command. The players concentrate on every roll, and the coach tells the players in which direction they should roll every time.
5 ROLLS PER SIDE
LEVEL 2: SLOWLY FROM A STANDING POSITION
STARTING POSITION: the players are standing straight, about 2 metres apart.
ACTION: the rolls learned in level 1 are now performed from a standing position. The players squat by bending their knees, looking downwards and moving the chin towards the chest. The hand movement should be slow and deliberate, so that the players can master the process. The roll movement is the same as for level 1.
5 ROLLS PER SIDE
LEVEL 3: DYNAMICALLY FROM A STANDING POSITION
STARTING POSITION: as level 2.
ACTION: the squatting posture adopted in level 2 is now performed more quickly and dynamically and the roll learned in level 1 is introduced dynamically.
5 ROLLS PER SIDE
LEVEL 4: FROM A SLOW WALK STARTING POSITION: It is important that the players are able to safely execute the fast rolls that they learned in level 3 from a standing position.
ACTION: the squatting and rolling actions learned in level 3 are now introduced from a slow walk.
LEVEL 5: FROM A FASTER FORWARD MOVEMENT STARTING POSITION: It is important that the players are able to safely execute the movement that they learned in level 4 in both directions. Only then can level 5 be attempted.
ACTION: as level 4, except from a faster forward movement (quick walking/jogging).
5 ROLLS PER SIDE
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] 301520 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] 306272 0
Overall 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).
Timepoint [1] 306272 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 injuries incurred for each player.
Secondary outcome [1] 348033 0
Lower extremity injuries. The lower extremity refers to the part of the body from the hip to the toes. The lower extremity includes the hip, knee, and ankle joints, and the bones of the thigh, leg, and foot.
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).
Timepoint [1] 348033 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 injuries incurred for each player.

Eligibility
Key inclusion criteria
Male
Soccer players
Must be between 7 and 13 years of age at the start of the study.
Training at least twice per week.
Minimum age
7 Years
Maximum age
13 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of 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
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 184 participants. which will be sufficient for this study, 92 in the intervention group, and 92 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
184
Accrual to date
Final
Recruitment outside Australia
Country [1] 10550 0
Saudi Arabia
State/province [1] 10550 0

Funding & Sponsors
Funding source category [1] 299751 0
University
Name [1] 299751 0
Umm Al Qura University
Country [1] 299751 0
Saudi Arabia
Primary sponsor type
University
Name
Umm Al Qura University
Address
Al Awali, Mecca 24381.
Country
Saudi Arabia
Secondary sponsor category [1] 299090 0
University
Name [1] 299090 0
The University of Sydney
Address [1] 299090 0
75 East Street, Lidcombe, NSW, 2141
Country [1] 299090 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300641 0
Umm Al Qura University - Research Ethics Committee
Ethics committee address [1] 300641 0
Al Awali, Mecca 24381.
Ethics committee country [1] 300641 0
Saudi Arabia
Date submitted for ethics approval [1] 300641 0
03/04/2018
Approval date [1] 300641 0
06/06/2018
Ethics approval number [1] 300641 0
FAMS11162018

Summary
Brief summary
The ‘11+ Kids’ is an exercise-based program to prevent soccer injuries in 7- to 13-year-old children. It was developed by an international group of experts based on the findings of an epidemiological study on injury incidence and characteristics in children’s football . The structure of the programme refers to the established ‘11+’ program, which has been shown to be efficacious in players aged older than 13 years.
The objective of this study is to evaluate the effect of the (‘11+ Kids’) program on reducing the incidence of injuries among children soccer players aged 7–13 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84310 0
A/Prof Wesam Saleh A. Al Attar
Address 84310 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84310 0
Saudi Arabia
Phone 84310 0
+966 54 820 6504
Fax 84310 0
Email 84310 0
wsattar@uqu.edu.sa
Contact person for public queries
Name 84311 0
A/Prof Wesam Saleh A. Al Attar
Address 84311 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84311 0
Saudi Arabia
Phone 84311 0
+966 54 820 6504
Fax 84311 0
Email 84311 0
wsattar@uqu.edu.sa
Contact person for scientific queries
Name 84312 0
A/Prof Wesam Saleh A. Al Attar
Address 84312 0
Umm Al Qura University
Faculty of Applied Medical Sciences
Department of Physiotherapy and Rehabilitation Sciences
Al Awali, Mecca 24381
Country 84312 0
Saudi Arabia
Phone 84312 0
+966 54 820 6504
Fax 84312 0
Email 84312 0
wsattar@uqu.edu.sa

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