The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001452280
Ethics application status
Approved
Date submitted
18/07/2017
Date registered
28/08/2018
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of a FIFA 11+ Injury Prevention Program after Fatigue Simulation Toward Strength, Dynamic Balance and Biomechanical Markers of Anterior Cruciate Ligament Injury Risk in Youth Soccer Players
Scientific title
The Effect of a FIFA 11+ Injury Prevention Program after Fatigue Simulation Toward Strength, Dynamic Balance and Biomechanical Markers of Anterior Cruciate Ligament Injury Risk in Youth Soccer Players
Secondary ID [1] 292453 0
Nil Known
Universal Trial Number (UTN)
U1111-1199-4186
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament injury 304065 0
Condition category
Condition code
Musculoskeletal 303659 303659 0 0
Other muscular and skeletal disorders
Injuries and Accidents 303660 303660 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Initially, participants will be familiarized with the protocol and assessment methods, This will be followed by 2 testing sessions which are separated by at least 3 days (Bossuyt et al., 2016). Both sessions included a dynamic warm-up, followed by the youth soccer fatigue simulation (YSFS5), a pretest (TIME 0), a test immediately following YSFS5 (TIME 5), after 15 min of passive rest (TIME 20) and after 30 min of passive rest (TIME 35). The distance for Youth Soccer Fatigue Simulation (YSFS5) is 12 meters and the time spent is 5 minutes. YSFS5 is using high-intensity exercises. Functional high-intensity movements were included in this simulation to make it more similar to the real soccer match. The participant needs to repeat the cycle of activities for 5 minutes. The action sequences are instructed using verbal cues on an audio recording. Before, during and after the simulation, the participant needs to be assessed in term of their heart rates, rates of perceived exertion (RPE) and heights of vertical jump. These monitored aspects are indicators to make sure the participant is a phase of high-intensity mode. If the participant is not in the mode, the oral encouragement should be applied to increase the desire of participant to be in the mode of high intensity. The YSFS5 consist of :

0. 6x Ball Passing
1 . Stand
2 . Up Jog
3. 6x Ball heading
4. Side Stride
5. Agility ladder drill + 1 x Ball shooting
6. VJ + up Jog
7. Sprint with a ball
8. Stand
9. Up Jog
10. 6x Ball Passing
11. VJ + up Jog
12. 6x Ball heading
13. Side Stride
14. Agility ladder drill + 1 x Ball shooting
15. Stand
16. Up Jog
17. 6x Ball Passing
18. VJ + up Jog
19. Jog
20. Up Jog
21. 6x Ball heading
22. VJ + Up Jog
23. Agility ladder drill + 1 x Ball shooting
24. Side Stride
25. Stand
26. 6x Ball Passing
27. Jog
28. Sprint with a ball
29. VJ
All these activities take about 5minutes.

After that, the participant will be randomly allocated to control and intervention group. Participants in the intervention group will be instructed to do FIFA 11+ program about 20minutes which are to use the complete exercise program as the warm up for at least two training sessions every week. The program has three parts. The initial part is running exercises at slow speed combined with active stretching and controlled contacts with a partner. The running course includes six to ten pairs of cones (depending on the number of players) about five to six meters apart (length and width). The running exercise such as running straight ahead and running quickly forwards and backward. The second part consists of six different sets of exercises; these include strength, balance, and jumping exercises, each with three levels of increasing difficulty. The second part example is the bench static, single leg stand and vertical jump. The final part is speed running combined with football-specific movements with bounding and plant-cut movements (Owoeye et al., 2014). This program will be completed by as part of a team warm up supervised by the coach. The training will be provided to the coach to run the program and also be given the handbooks. The researcher will monitor the program twice a week. The coach will keep a diary of program completion and player attendance to monitor the intervention program process. This intervention will be done for 8 weeks. Then all the participants will come back to the lab for repeating the same procedure for the outcome measure before YSFS5 and after YSFS5. The data collection will be assessed by the assessors who are blinded from the control and intervention group. In addition, the same assessors will be collected the data for pre and post-intervention.
Intervention code [1] 298631 0
Prevention
Comparator / control treatment
Control group followed its regular training routine, usually without a structured warm-up program.
Control group
Active

Outcomes
Primary outcome [1] 302779 0
Muscle strength will be collected using isokinetic machine Biodex system 4
Timepoint [1] 302779 0
Before Intervention:
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

After Intervention(end of 8 weeks):
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation
Primary outcome [2] 302780 0
The dynamic balance will be measured using modified Star Excursion Balance Tes (SEBT )(Y Balance Test).
Timepoint [2] 302780 0
Before Intervention:
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

After Intervention(end of 8 weeks):
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation
Primary outcome [3] 302781 0
Landing Error Scoring System checklist with two digital video cameras will be placed 3 m in front of and to the right of the participants to capture frontal and sagittal images of all jump-landing trials.
Timepoint [3] 302781 0
Before Intervention:
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

After Intervention(end of 8 weeks):
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation
Secondary outcome [1] 336989 0
Heart rate using polar heart rate watch
Timepoint [1] 336989 0
Before Intervention:
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

After Intervention(end of 8 weeks):
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation
Secondary outcome [2] 336990 0
Vertical jump using My Jump 2 application
Timepoint [2] 336990 0
Before Intervention:
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

After Intervention(end of 8 weeks):
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation
Secondary outcome [3] 336991 0
Rated perceived exertion scale
Timepoint [3] 336991 0
Before Intervention:
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

After Intervention(end of 8 weeks):
1) before youth soccer fatigue simulation
2) immediately after youth soccer fatigue simulation
3) 15 minutes after youth soccer fatigue simulation
4) 30 minutes after youth soccer fatigue simulation

Eligibility
Key inclusion criteria
1. Male with age between 14 – 18 years old
2. Participated in at least one season of high school soccer
3. Regularly play soccer within 3 to 5 times per week with duration of 40 to 60 minutes per
session
4 Nonsmokers
Minimum age
14 Years
Maximum age
18 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Anyone with a history of lower extremity or low back pain, or cardiovascular or systemic
conditions that limited physical activity
2. Subject has undergone lower limb injury within the last 6 months.
3. On ergogenic aid or medication users

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (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
An a-priory calculation for sample size determination has been conducted from previous studies (Daneshjoo, Mokhtar, Rahnama, & Yusof, 2012) It was determined that to achieve 80% statistical power and an effect size of 0.514, a minimum number of 32 participants is required for this study. A 20% was added to reduce the possibility of the attrition rate. Therefore, 40 participants will be recruited.
Descriptive statistics of outcome measures will include means and standard deviations. A one-way repeated measures analysis of variance (ANOVA) will be used to investigate the influence of Youth Soccer Fatigue Simulation(YSFS5) on each dependent variable using statistical software package SPSS (Version 23; SPSS Inc., USA). Mauchly's test of sphericity will be used to check for equality of variance between simulations and different times. If the Greenhouse–Geisser epsilon will be >0.75 the Huynh Feldt correction will be used, if the epsilon was <0.75 the Greenhouse Geisser correction value will be used (Girden, 1992). Bonferroni procedures will be used for post-hoc analysis and alpha level was set at 0.05.

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] 9061 0
Malaysia
State/province [1] 9061 0
SELANGOR

Funding & Sponsors
Funding source category [1] 297245 0
Self funded/Unfunded
Name [1] 297245 0
Saiful Adli bin Bukry
Address [1] 297245 0
Physiotherapy Department
Univeristi Teknologi MARA
Selangor,Malaysia
Country [1] 297245 0
Malaysia
Primary sponsor type
Individual
Name
Saiful Adli Bukry
Address
Physiotherapy Department
Universiti Teknologi MARA
Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 296020 0
None
Name [1] 296020 0
none
Address [1] 296020 0
none
Country [1] 296020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298206 0
Universiti Teknologi MARA Research Ethics Committee
Ethics committee address [1] 298206 0
Universiti Teknologi MARA
Level 3, Block Wawasa
40450 Shah Alam, Selangor, Malaysia
Ethics committee country [1] 298206 0
Malaysia
Date submitted for ethics approval [1] 298206 0
21/03/2017
Approval date [1] 298206 0
20/06/2017
Ethics approval number [1] 298206 0
REC/77/17

Summary
Brief summary
The recent finding showed that fatigue would lead to the increased risk of anterior cruciate ligament(ACL) injuries. The objectives of this study are to develop of soccer specific fatigue simulation for youth soccer players and to determine the effect of soccer specific fatigue simulation on muscle strength, dynamic balance, and biomechanical markers of ACL injury risk after eight weeks FIFA 11+ injury prevention warm up. Forty male participants, age 14 – 18 years, regularly play soccer for 3 to 5 times per week will be recruited in this study. Soccer players will be recruited from the school around the Selangor. The new soccer specific fatigue simulation will be modified based on previous protocol and pilot observation. The temporal physiological responses (heart rate and rate of perceived exertion) will be monitor during the simulation. After that, an investigation of the effect of the new developed soccer specific fatigue simulation for youth (YSFS5) on muscle strength, dynamic balance and biomechanical markers of ACL injury during landing task will be conducted. During the testing session, players will be assigned to perform the YSFS5. Heart rate and RPE will be monitored at selected times throughout the protocol. Prior to YSFS5 (time 0 min), immediately after YSFS5 (time 5 min) and after 15 min of passive rest (time 20 min), and 30 min passive rest (time 35 min ) players will perform muscle strength on an isokinetic dynamometer, dynamic balance (modified star execution balance test) and landing task biomechanical assessments (Landing Error Scoring System). Then, the participants in the intervention group will be instructed to do FIFA 11+ which is to use the complete exercise program as the warm up for at least two training sessions every week. This intervention will be done for eight weeks. While the control group followed its regular training routine, usually without a structured warm-up program. After completing the session of FIFA 11+ participant will be back to the laboratory to repeat the same procedure of tests. This study will generate a better understanding of how fatigue induced by a newly develop soccer specific fatigue simulation (YSFS5) influence muscle strength. Dynamic balance and biomechanical changes related to ACL injury risk. This study may also create a new injury screening procedures as part of soccer players pre-season and return to play assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76334 0
Mr Saiful Adli Bukry
Address 76334 0
Physiotherapy Department
Univesity Teknologi MARA
42300 Puncak Alam
Selangor, Malaysia
Country 76334 0
Malaysia
Phone 76334 0
+6019-6216995
Fax 76334 0
Email 76334 0
saiful_adli@salam.uitm.edu.my
Contact person for public queries
Name 76335 0
Dr Mohd Haidzir Abd Manaf
Address 76335 0
Level 14, Block FSK 6
Universiti Teknologi MARA
Campus Puncak Alam
42300 Puncak Alam
Selangor
Country 76335 0
Malaysia
Phone 76335 0
+6012-6615246
Fax 76335 0
Email 76335 0
haidzir5894@puncakalam.uitm.edu.my
Contact person for scientific queries
Name 76336 0
Dr Raja Mohammed Firhad Raja Azidin
Address 76336 0
Sports Science and Recreation,
Universiti Teknologi MARA
40450 Shah Alam
Selangor
Country 76336 0
Malaysia
Phone 76336 0
+6012-3485356
Fax 76336 0
Email 76336 0
firhad@salam.uitm.edu.my

No data has been provided for results reporting
Summary results
Not applicable