NCT07713004

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 13, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

FIFA 11+Neuromuscular warm-upInjury preventionMove2PerformFunctional Movement ScreenY-Balance TestYouth soccerRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Change in Move2Perform Injury Risk Category

    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.

    Baseline and immediately after completion of the 8-week intervention

  • Number of Time-Loss Injuries

    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.

    From the first intervention session through completion of week 8

Secondary Outcomes (7)

  • Change in Lower Quarter Y-Balance Test Composite Score

    Baseline and immediately after completion of the 8-week intervention

  • Change in Functional Movement Screen Total Score

    Baseline and immediately after completion of the 8-week intervention

  • Change in Three-Consecutive Double-Leg Horizontal Jump Distance

    Baseline and immediately after completion of the 8-week intervention

  • Change in Three-Consecutive Right Single-Leg Horizontal Jump Distance

    Baseline and immediately after completion of the 8-week intervention

  • Change in Three-Consecutive Left Single-Leg Horizontal Jump Distance

    Baseline and immediately after completion of the 8-week intervention

  • +2 more secondary outcomes

Study Arms (2)

FIFA 11+ Group

EXPERIMENTAL

Participants performed the complete FIFA 11+ neuromuscular warm-up program three times per week for eight weeks prior to regular training, each session lasting approximately 20 minutes, under the supervision of a certified physiotherapist.

Other: FIFA 11+ Neuromuscular Warm-Up Program

Control Group

ACTIVE COMPARATOR

Participants continued their routine pre-training warm-up over the same eight-week period, with no additional structured neuromuscular component.

Other: Routine Warm-Up

Interventions

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.

FIFA 11+ Group

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

Control Group

Eligibility Criteria

Age15 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University, Sports Sciences and Technology Research and Application Center

Denizli, Pamukkale, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Athletic InjuriesSprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Investigators who administered the Functional Movement Screen, Lower Quarter Y-Balance Test, jump tests, and strength assessments at baseline and post-intervention were blinded to group allocation. Due to the nature of the intervention, participants and the supervising physiotherapist could not be blinded. Data were de-identified prior to statistical analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two parallel groups: an experimental group performing the FIFA 11+ neuromuscular warm-up program and a control group continuing its routine pre-training warm-up. Outcomes were assessed at baseline and after the eight-week intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 20, 2026

Study Start

August 20, 2024

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations