Healthy Young Soccer PlayersNCT06501833
Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players
A study testing FIFA 11+ KIDS PROGRAM and REGULAR TRAINING in people with Healthy Young Soccer Players, run by Imam Abdulrahman Bin Faisal University.
Trial summary
Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. Read more about this study
- Who is it for?
- Ages 7 to 13 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Soccer Players
- What is being tested?
- FIFA 11+ KIDS PROGRAM and REGULAR TRAINING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- Men only
- Healthy volunteers accepted
- Child
The inclusion criteria are
- Healthy male young soccer players between the ages of 7-13 (al Attar et al., 2022).
- Playing experience of at least one year.
- Participating in a training session at least three times per week (Teixeira et al., 2021).
- Participating in training at least 4.5 hours a week.
The exclusion criteria:
- Upper or lower limb injuries require medical attention within the last six months (al Attar et al., 2022).
- Any systemic disease, cardiovascular, neurological disorders, or surgery may affect the measurement and participation as reported by the participants (al-Attar et al., 2022).
- Any medication which may affect the training or measurement as reported by the participants.
- Any biomechanical abnormalities as reported by the participants.
- Missed two consecutive training sessions or three separate ones (Mirwald et al., 2002).
- Missing one of the testing sessions (Mirwald et al., 2002). -
About this study
Official title: Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players- A Randomized Controlled Trial
Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. High injury rates have been observed in both adult and young players, which has prompted the development of various preventive measures. FIFA recently introduced the FIFA 11+ Kids program for children under 14 to prevent soccer injuries and enhance kids' performance. To date, no studies have been done to determine whether adding the FIFA 11 + kids program for young players under 14 will enhance soccer-specific skills.
Objective: To investigate the efficacy of FIFA 11+ Kids on soccer-specific skills among young soccer players.
Read more
Methods: Thirty six young soccer players (aged 7-13) will be assigned randomly to the following groups: the control group (n =18) and the FIFA 11+ Kids program (n = 18). The experimental group will perform eight weeks of FIFA 11+ kids program (3/week). The control group will be instructed to continue their regular training . Three soccer specific skills tests : the Slalom dribble test, Harre circuit test, and Loughborough soccer passing test, will be done before and after eight weeks of training.
Statistical analysis: IBM SPSS software (version 20) will be used for all statistical analyses. Data will be summarized in terms of mean and SD. Normality is checked with the Shapiro-Wilk test and homogeneity with Levene's tests. If the data are normally distributed, a paired t-test will be used for within-group difference comparison, and an independent t-test will be used for between-group comparison. If the data are not normally distributed, the Wilcoxon-Signed rank and Mann-Whitney U tests will be used.
- Conditions
- Healthy Young Soccer Players
- Being tested
- FIFA 11+ KIDS PROGRAM, REGULAR TRAINING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11+ KIDS PROGRAMOther
The experimental group will perform eight weeks of FIFA 11+ kids program (3/week).
REGULAR TRAININGOther
The control group will be continuing their regular training
| Study group | Role | What they receive |
|---|---|---|
| FIFA 11+ kids program group | Experimental | Not described Receives: Other: FIFA 11+ KIDS PROGRAM |
| Regular training group | Active comparator | Not described Receives: Other: REGULAR TRAINING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slalom dribble test
Measured: pre and immediately post intervention
Harre circuit test
Measured: pre and immediately post intervention
Loughborough soccer passing test
Measured: pre and immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young Soccer PlayersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shibili Nuhmani, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501833
- Sponsor's protocol ID
- IRB-PGS-2023-03-254
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06501833
- Acronym / sponsor ID
- IRB-PGS-2023-03-254
- Conditions
- Healthy Young Soccer Players
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. High injury rates have been observed in both adult and young players, which has prompted the development of various preventive measures. FIFA recently introduced the FIFA 11+ Kids program for children under 14 to prevent soccer injuries and enhance kids' performance. To date, no studies have been done to determine whether adding the FIFA 11 + kids program for young players under 14 will enhance soccer-specific skills.
Objective: To investigate the efficacy of FIFA 11+ Kids on soccer-specific skills among young soccer players.
Methods: Thirty six young soccer players (aged 7-13) will be assigned randomly to the following groups: the control group (n =18) and the FIFA 11+ Kids program (n = 18). The experimental group will perform eight weeks of FIFA 11+ kids program (3/week). The control group will be instructed to continue their regular training . Three soccer specific skills tests : the Slalom dribble test, Harre circuit test, and Loughborough soccer passing test, will be done before and after eight weeks of training.
Statistical analysis: IBM SPSS software (version 20) will be used for all statistical analyses. Data will be summarized in terms of mean and SD. Normality is checked with the Shapiro-Wilk test and homogeneity with Levene's tests. If the data are normally distributed, a paired t-test will be used for within-group difference comparison, and an independent t-test will be used for between-group comparison. If the data are not normally distributed, the Wilcoxon-Signed rank and Mann-Whitney U tests will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIFA 11+ kids program group | Experimental | Other: FIFA 11+ KIDS PROGRAM |
| Regular training group | Active comparator | Other: REGULAR TRAINING |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIFA 11+ KIDS PROGRAMThe experimental group will perform eight weeks of FIFA 11+ kids program (3/week). | Other | FIFA 11+ kids program group |
| REGULAR TRAININGThe control group will be continuing their regular training | Other | Regular training group |
Primary outcome
Slalom dribble test
Time frame: pre and immediately post intervention
Harre circuit test
Time frame: pre and immediately post intervention
Loughborough soccer passing test
Time frame: pre and immediately post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA 11+ KIDS PROGRAM and REGULAR TRAINING in people with Healthy Young Soccer Players, run by Imam Abdulrahman Bin Faisal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slalom dribble test (time frame: pre and immediately post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.