Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000359639
Ethics application status
Approved
Date submitted
22/02/2023
Date registered
6/04/2023
Date last updated
6/04/2023
Date data sharing statement initially provided
6/04/2023
Date results provided
6/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a newly designed daily exercise program in reducing the number of injuries in young football (soccer) players
Scientific title
To assess the effect on injury incidence and severity in youth male football of a newly designed exercise-based injury prevention program (five times a week) in comparison with the FIFA11+ and the FIFA11+ Kids programs (twice a week)
Secondary ID [1] 308983 0
None
Universal Trial Number (UTN)
U1111-1288-3997
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee sprain 328996 0
Patellar tendinopathy 328997 0
Osgood-Schlatter disease 328998 0
Hamstring muscle injuries 328999 0
Quadricep muscle injuries 329000 0
Groin and hip muscle injuries 329001 0
Ankle sprain 329002 0
Calf muscle injuries 329003 0
Achilles tendinopathy 329004 0
Sever’s disease 329005 0
Condition category
Condition code
Musculoskeletal 325983 325983 0 0
Other muscular and skeletal disorders
Injuries and Accidents 326421 326421 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily exercise-based injury prevention program (IPP).
The IPP consists in one session a day for five days a week (training days), to be performed either at home (unsupervised) or in the football academy gym (before football training) under medical staff supervision, with none or minimal equipment required. When players performed the IPP in the academy gym, they were supervised in groups of 5-15 players, depending on the number of players attending football training session on that day. Each session was designed to last 10 minutes and consists of a circuit of four exercises repeated for two sets, with a 1-minute rest in between. Each exercise includes three variations (LEVEL 1-3) to ensure a progression to meet the physical characteristics of the different age groups and of each player. For example, in order to increase hip adductors muscle strength, players progressed from side-lying hip adduction exercise (LEVEL 1) to ball squeeze (LEVEL 2) and Copenhagen exercise (LEVEL 3), whereas double leg calf raise (LEVEL 1), single leg calf raise (LEVEL 2) and single leg calf raise on step (LEVEL 3) were prescribed to improve calf muscle strength. Players from under 9 (U9) to U11 started performing the LEVEL 1, while players from U12 to U15 and from U16 to U18 began with LEVEL 2 and 3, respectively. They gradually progressed at their own pace, and when they perceived the exercise as too easy, they increased the number of repetitions and then move on to the next level. However, when they perceived the level as being too difficult, they could execute the easier level. Players had to perceive the exercise as a "hard intensity" exercise, but no specific objective scale was used to measure the exercise intensity perceived. The IPP was performed over a 6-month period, and the participants were reviewed on a weekly basis during the IPP execution, to evaluate if they needed to move up or down a level. The rationale behind this approach was to implement an IPP consisting of different sessions short in duration, easy to perform, and without need of costly equipment and/or space, to encourage the players’ adherence while targeting risk factors for the most common injuries in youth football. All players, their parents and/or guardians, and the medical staff were informed about the IPP design, and they were provided with a document showing the IPP exercises and describing how to perform them. Moreover, theoretical and practical training sessions were given to physiotherapists to ensure a high quality supervision and the players were instructed on how to perform the IPP correctly. The players' adherence to the IPP was not evaluated.
Intervention code [1] 325425 0
Prevention
Comparator / control treatment
FIFA11+ and FIFA11+ Kids programs.
Players in the control group from age 14 and above performed The FIFA11+, while the younger players executed The FIFA11+ Kids. These programs were carried out pitch-side by a medical staff member (physiotherapist) twice a week as a pre-training warm-up for 15-20 minutes each session. The FIFA11+ and FIFA11+ Kids programs were delivered over a 6-month period. The FIFA 11+ program involves running, stretching, contacts, strength, balance, jumping, and change of direction exercises, and it includes 3 levels of progression for the strengthening, plyometric and balance sections. On the other hand, the FIFA 11+ Kids program aims to improve spatial orientation, anticipation, attention, stability, coordination, and appropriate falling techniques, including 5 different progression levels for all the exercises. During the warm-up session, players were reviewed on a weekly basis to assess whether they needed to move up or down a level. Players had to perceive the exercises as a "hard intensity" exercises, but no specific objective scale was used to measure the exercise intensity perceived. These neuromuscular preventative programs have been selected because their effect in reducing injury incidence and severity in football has been widely demonstrated. All players, their parents and/or guardians, and the medical staff were informed about the FIFA11+ and FIFA11+ Kids structure and progression. Moreover, theoretical and practical training sessions were given to physiotherapists to ensure a high quality supervision. They were also provided with online URLs where they could find these programs' manual, poster and video demonstrations. The players' adherence to the FIFA11+ and FIFA11+ Kids programs was not evaluated.
Control group
Active

Outcomes
Primary outcome [1] 333839 0
Injury Incidence assessed by an audit of study-specific injury
Timepoint [1] 333839 0
Cumulative data was assessed at the conclusion of the 6 months study period
Primary outcome [2] 333840 0
Injury severity assessed as the number of training days lost due to injury as reported by medical staff
Timepoint [2] 333840 0
Cumulative data was assessed at the conclusion of the 6 months study period
Secondary outcome [1] 418447 0
Nil
Timepoint [1] 418447 0
Nil

Eligibility
Key inclusion criteria
- Registered academy players
Minimum age
8 Years
Maximum age
18 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Informed consent form not returned by the established date (signed by them and their parents/guardians)
- Being severely injured (more than 28 days lost) at the time the interventions started

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)
Allocation was concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was stratified by age and previous injuries in the preceding year
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
Sample size consisted in the maximum numbers of football players registered in the academy where the study was conducted, meeting the inclusion criteria and accepting to participate in the study. No sample size calculations were performed. The statistical significance of the injury incidence rate ratio (IRR) was evaluated to compare the treatments’ effectiveness. The injury incidence rate (IR) was defined in each group as the ratio between the number of injuries and the number of exposure hours x 1000. Moreover, the IRR was defined as the ratio between the injuries IR of the intervention (INT) and the control (CON) groups, and its statistical significance was assessed by using the Ederer-Mantel test. Regarding injury severity, the Mann-Whitney test was used to assess if there was any statistically significant difference between the median number of days lost to injury in the INT and CON groups. A Cumulative-Logit model with proportional odds and generalized estimating equations was adopted in order to model the relationship between the injury severity and the program performed. The correlation of multiple injuries occurring in the same individual was adjusted by using generalized estimating equations in the proportional odds model. As secondary analysis, the Ederer-Mantel test was used to evaluate the injury IRR in each age class (U9-U12; U13-U16; U18) while the Cumulative-Logit model with proportional odds and generalized estimating equations was estimated using the program performed and age classes as covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2021
Date of last participant enrolment
Anticipated
Actual
23/09/2021
Date of last data collection
Anticipated
Actual
1/05/2022
Sample size
Target
120
Accrual to date
Final
93
Recruitment outside Australia
Country [1] 25260 0
United Kingdom
State/province [1] 25260 0
England

Funding & Sponsors
Funding source category [1] 313203 0
Other
Name [1] 313203 0
Stevenage Football Club
Country [1] 313203 0
United Kingdom
Primary sponsor type
Individual
Name
Matteo Brunelli
Address
West Ham United Football Club, London Stadium, Queen Elizabeth Olympic Park, London, E20 2ST
Country
United Kingdom
Secondary sponsor category [1] 314910 0
University
Name [1] 314910 0
University of Bath
Address [1] 314910 0
Claverton Down, Bath BA2 7AY
Country [1] 314910 0
United Kingdom
Other collaborator category [1] 282557 0
Individual
Name [1] 282557 0
Giulia Brunelli
Address [1] 282557 0
Università degli Studi di Siena, via Banchi di Sotto 55, 53100, Siena, Italy
Country [1] 282557 0
Italy
Other collaborator category [2] 282558 0
Individual
Name [2] 282558 0
Eamonn Delahunt
Address [2] 282558 0
University College Dublin, Belfield, Dublin 4
Country [2] 282558 0
Ireland
Other collaborator category [3] 282559 0
Individual
Name [3] 282559 0
Cassie Wilson
Address [3] 282559 0
University of Bath, Claverton Down, Bath BA2 7AY
Country [3] 282559 0
United Kingdom
Other collaborator category [4] 282562 0
Individual
Name [4] 282562 0
Sebastiano Nutarelli
Address [4] 282562 0
Sports Rehab Lugano, Via Serafino Balestra 11, 6900 Lugano
Country [4] 282562 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312429 0
SEM & SPY Research Ethics Approval Committee (SSREAC)
Ethics committee address [1] 312429 0
Ethics committee country [1] 312429 0
United Kingdom
Date submitted for ethics approval [1] 312429 0
21/06/2021
Approval date [1] 312429 0
01/09/2021
Ethics approval number [1] 312429 0
SSREAC 2021-014

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

Contacts
Principal investigator
Name 124634 0
Mr Matteo Brunelli
Address 124634 0
West Ham United Football Club, London Stadium, Queen Elizabeth Olympic Park, London, E20 2ST
Country 124634 0
United Kingdom
Phone 124634 0
+44 7563 833987
Fax 124634 0
Email 124634 0
[email protected]
Contact person for public queries
Name 124635 0
Matteo Brunelli
Address 124635 0
West Ham United Football Club, London Stadium, Queen Elizabeth Olympic Park, London, E20 2ST
Country 124635 0
United Kingdom
Phone 124635 0
+44 7563 833987
Fax 124635 0
Email 124635 0
[email protected]
Contact person for scientific queries
Name 124636 0
Matteo Brunelli
Address 124636 0
West Ham United Football Club, London Stadium, Queen Elizabeth Olympic Park, London, E20 2ST
Country 124636 0
United Kingdom
Phone 124636 0
+44 7563 833987
Fax 124636 0
Email 124636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (email address: [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18336Informed consent form  [email protected] 385394-(Uploaded-19-02-2023-04-33-47)-Study-related document.pdf
18338Ethical approval  [email protected] 385394-(Uploaded-19-02-2023-04-34-16)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.