NCT06846008

Brief Summary

The goal of this clinical trial is to find out if a coach-focused intervention can help prevent sudden-onset, severe knee injuries in youth and senior amateur football players. The main question it aims to answer is: Does a coach-focused intervention reduce the number of sudden-onset, severe knee injuries? Researchers will compare a coach-focused intervention, designed to help coaches to use effective injury prevention training, to usual football practice to see if the intervention can prevent sudden-onset, severe knee injuries in football players. Participants will: Either receive weekly information and motivation on effective injury prevention training or continue their usual football practice for 14 weeks. All will receive a weekly text message with a survey link to report any sudden-onset knee injuries among their players for 18 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

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

First Submitted

Initial submission to the registry

February 11, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 23, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

February 11, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

knee injuryinjury prevention trainingfootballcoachesplayers

Outcome Measures

Primary Outcomes (1)

  • The incidence of acute severe knee injuries in players.

    The difference in incidence of acute severe knee injuries (\>28 time-loss days from training and matches) per 1000 hours of player exposure in players belonging to coaches in the intervention group compared with players belonging to coaches in the control group (usual practice) throughout the intervention period.

    From baseline to end of the intervention, 14 weeks after baseline.

Secondary Outcomes (9)

  • Incidence of acute knee injuries

    From baseline to end of the intervention, 14 weeks after baseline.

  • Incidence of acute minimal knee injuries

    From baseline to end of the intervention, 14 weeks after baseline.

  • Incidence of acute mild knee injuries

    From baseline to end of the intervention, 14 weeks after baseline.

  • Incidence of acute moderate knee injuries

    From baseline to end of the intervention, 14 weeks after baseline.

  • Time-loss days of acute knee injuries

    From baseline to end of the intervention, 14 weeks after baseline.

  • +4 more secondary outcomes

Study Arms (2)

Injury prevention training

EXPERIMENTAL

Evidence-based injury prevention training programs and exercises will be send weekly to participants in the intervention arm. Additionally, participants in the intervention arm will be encouraged to access a study specific online platform containing information, inspiration, pep-talks and posters on injury prevention training.

Usual practice

ACTIVE COMPARATOR

Usual training

Other: Usual Practice

Interventions

Evidence-based injury prevention training programs and exercises will be send weekly to participants in the intervention arm. Additionally, participants in the intervention arm will be encouraged to access a study specific online platform containing information, inspiration, pep-talks and posters on injury prevention training.

Usual training

Usual practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coach or manager at Danish amateur football teams at levels from under 14 (U14) years to senior teams.
  • Minimum 18 years of age.
  • Access to a mobile phone and computer.

You may not qualify if:

  • Limited Danish language skills, which prevents full understanding of the provided material and questionnaires.
  • Affiliation to teams playing under a license ranking by the Danish Football Association where training by a physical trainer is required according to the license criteria of the Danish Football Association).
  • Affiliation solely with old boys'/girls' teams (where the players have to be aged 32 and 29 , respectively, in the current season ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Elisabeth Bandak, PhD

    The Parker Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 25, 2025

Study Start

February 23, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

IPD can upon rasonable request to the investigator be shared.

Locations