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Completed

NCT Number: NCT07713004

FIFA 11+ Warm-Up and Injury Risk Classification in Youth Amateur Soccer Players

This randomized controlled trial evaluated whether an eight-week, supervised FIFA 11+ neuromuscular warm-up program improves multifactorial injury risk classification, functional performance, and time-loss injury incidence in youth amateur male soccer players aged 15 to 18 years.

Forty-four players from a regional amateur league were randomly allocated to either the FIFA 11+ group or a control group that continued its routine pre-training warm-up. Injury risk was classified using the Move2Perform algorithm, which integrates demographic data, injury history, the Functional Movement Screen (FMS), and the Lower Quarter Y-Balance Test (YBT-LQ). Jump performance and isometric lower extremity strength were also assessed at baseline and after eight weeks. Time-loss injuries were recorded prospectively throughout the intervention period.

This study was registered retrospectively.

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Key information

Age range

15 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University, Sports Sciences and Technology Research and Application Center

Denizli, Pamukkale, 20000, Turkey (Türkiye)

About this study

Background. Lower extremity injuries are a major burden in youth soccer. Isolated screening tools such as the Functional Movement Screen (FMS) and the Lower Quarter Y-Balance Test (YBT-LQ) have shown limited standalone predictive accuracy, whereas multifactorial classification frameworks may better identify at-risk athletes. The FIFA 11+ program is an established neuromuscular warm-up shown to reduce injury incidence, but its combined application with multifactorial risk classification has been studied mainly in collegiate and elite cohorts, leaving youth amateur players underrepresented.

Design. Parallel-group, single-blinded randomized controlled trial. Outcome assessments were performed at baseline and after eight weeks. All testing took place on the natural grass field where the athletes regularly trained, under standard training conditions. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Randomization and blinding. After baseline assessment, participants were allocated 1:1 using computer-generated block randomization with a block size of four. The allocation sequence was prepared by an independent researcher not involved in data collection or analysis, and assignments were concealed from the recruiting investigator until after baseline testing. Investigators administering the FMS, YBT-LQ, jump tests, and strength assessments at both time points were blinded to group allocation. Participants and the supervising physiotherapist could not be blinded due to the nature of the intervention. Data were de-identified prior to statistical analysis.

Intervention. The experimental group performed the complete FIFA 11+ program three times per week for eight weeks before regular training, each session lasting approximately 20 minutes, supervised throughout by a certified physiotherapist who monitored technical execution, progressed exercise difficulty when criteria were met, and provided real-time correction to ensure intervention fidelity. The control group continued its routine pre-training warm-up over the same period.

Sample size. An a priori power analysis (G*Power 3.1; F-test, repeated measures within-between interaction) indicated a minimum total sample of 34 participants to detect a moderate effect (f = 0.25) for the Group x Time interaction with alpha = 0.05 and power = 0.80. Forty-four participants were enrolled.

Statistical analysis. A mixed-design (2x2) ANOVA assessed Group x Time interactions. Within-group changes were examined with paired t-tests following confirmation of normality using the Shapiro-Wilk test. Effect sizes were reported as Cohen's d and partial eta-squared. Bonferroni correction was applied to post hoc comparisons. Between-group injury incidence was compared using Fisher's exact test, with relative risk and 95% confidence intervals reported. Significance was set at p < 0.05.

Registration note. This trial was registered retrospectively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, aged 15 to 18 years
  • Minimum of one year of competitive experience in an amateur soccer league
  • Actively competing in the Mugla Regional Amateur League at the time of enrolment
  • No diagnosed systemic disease
  • Written informed consent from a parent or legal guardian and written assent from the participant

Exclusion criteria

  • Pain reported at the time of baseline assessment
  • Injury sustained within the six months preceding the study

Treatment and study plan

FIFA 11+ Neuromuscular Warm-Up Program

Other

The FIFA 11+ program comprises three sequential parts performed as a complete warm-up: (1) an initial running-based warm-up; (2) a central section of strength, plyometric, and balance exercises targeting neuromuscular control and core stability, progressed across three levels of difficulty; and (3) a final part of higher-speed running drills incorporating planting and cutting movements. Performed three times weekly for eight weeks, approximately 20 minutes per session, before regular training. All sessions were supervised by a certified physiotherapist who monitored technical execution, progressed exercise difficulty when criteria were met, and provided real-time correction to ensure intervention fidelity.

Routine Warm-Up

Other

The team's usual pre-training warm-up routine, continued unchanged for eight weeks with no additional structured neuromuscular component.

Primary outcomes

  1. Change in Move2Perform Injury Risk Category

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Injury risk is assessed using the Move2Perform injury risk classification system (Move2Perform LLC, Evansville, IN, USA). Each participant is assigned to one of four ordinal risk categories: Slight Risk, Moderate Risk, Substantial Risk, or High Risk. The outcome is the change in the assigned risk category from baseline to week 8. A shift toward a lower-risk category indicates improvement. The unit of measure is the ordinal risk category.

  2. Number of Time-Loss Injuries

    Time frame: From the first intervention session through completion of week 8

    The total number of time-loss injury events sustained during training or match play is recorded prospectively. A time-loss injury is defined as any physical complaint that prevents the participant from taking full part in a subsequent training session or match for at least 24 hours. The unit of measure is the number of injuries. Fewer injuries indicate a better outcome.

Secondary outcomes

  1. Change in Lower Quarter Y-Balance Test Composite Score

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Dynamic balance is assessed using the Lower Quarter Y-Balance Test. The composite score is calculated from the maximal anterior, posteromedial, and posterolateral reach distances normalized to limb length and expressed as a percentage. Change is calculated as the week 8 score minus the baseline score. The unit of measure is percentage of limb length (%). Higher positive change values indicate greater improvement in dynamic balance.

  2. Change in Functional Movement Screen Total Score

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Functional movement quality is assessed using the seven-item Functional Movement Screen. Each item is scored from 0 to 3, producing a total score ranging from 0 to 21 points. Change is calculated as the week 8 total score minus the baseline total score. The unit of measure is points. Higher positive change values indicate greater improvement in functional movement quality.

  3. Change in Three-Consecutive Double-Leg Horizontal Jump Distance

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Horizontal jump performance is assessed using three consecutive double-leg horizontal jumps. The total distance covered across the three jumps is recorded in centimeters. Change is calculated as the week 8 distance minus the baseline distance. The unit of measure is centimeters (cm). Higher positive change values indicate greater improvement in jump performance.

  4. Change in Three-Consecutive Right Single-Leg Horizontal Jump Distance

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Right single-leg horizontal jump performance is assessed using three consecutive horizontal jumps performed on the right leg. The total distance covered across the three jumps is recorded in centimeters. Change is calculated as the week 8 distance minus the baseline distance. The unit of measure is centimeters (cm). Higher positive change values indicate greater improvement in right single-leg jump performance.

  5. Change in Three-Consecutive Left Single-Leg Horizontal Jump Distance

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Left single-leg horizontal jump performance is assessed using three consecutive horizontal jumps performed on the left leg. The total distance covered across the three jumps is recorded in centimeters. Change is calculated as the week 8 distance minus the baseline distance. The unit of measure is centimeters (cm). Higher positive change values indicate greater improvement in left single-leg jump performance.

  6. Change in Isometric Quadriceps Strength

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Maximal isometric quadriceps strength is assessed using a Powertrak handheld dynamometer (JTech Medical, Utah, USA). The highest recorded value across the maximal voluntary contraction trials is used for analysis. Change is calculated as the week 8 value minus the baseline value. The unit of measure is newtons (N). Higher positive change values indicate greater improvement in quadriceps strength.

  7. Change in Isometric Hamstring Strength

    Time frame: Baseline and immediately after completion of the 8-week intervention

    Maximal isometric hamstring strength is assessed using a Powertrak handheld dynamometer (JTech Medical, Utah, USA). The highest recorded value across the maximal voluntary contraction trials is used for analysis. Change is calculated as the week 8 value minus the baseline value. The unit of measure is newtons (N). Higher positive change values indicate greater improvement in hamstring strength.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effects of the FIFA 11+ Neuromuscular Warm-Up Program on Move2Perform Injury Risk Classification in Youth Amateur Soccer Players: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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