- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06846008
The Effectiveness of a Coach-Focused Intervention on Preventing Knee Injuries in Amateur Football Players
The Effectiveness of a Coach-Focused Intervention on Preventing Acute Severe Knee Injuries in Amateur Football Players: A Cluster Randomized Superiority Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frederiksberg, Denmark, 2000
- The Parker Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 ).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Injury prevention training
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. |
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. |
|
Active Comparator: Usual practice
Usual training
|
Usual training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of acute severe knee injuries in players.
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of acute knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in incidence of all acute knee injuries (from minimal (1-3 days lost) to severe (>28 time-loss days from training or match)) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Incidence of acute minimal knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in incidence of acute minimal knee injuries (1-3 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Incidence of acute mild knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in incidence of acute mild knee injuries (4-7 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Incidence of acute moderate knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in incidence of acute moderate knee injuries (8-28 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Time-loss days of acute knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in burden of all acute knee injuries (the total number of time loss days from minimal (1-3 time-loss days) to severe (>28 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Time-loss days of acute minimal knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in burden of acute minimal knee injuries (1-3 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Time-loss days of acute mild knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in burden of acute mild knee injuries (4-7 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Time-loss days of acute moderate knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in burden of acute moderate knee injuries (8-28 time-loss days from training or match) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
|
Time-loss days of acute severe knee injuries
Time Frame: From baseline to end of the intervention, 14 weeks after baseline.
|
The difference in burden of acute and severe knee injuries (> 28 time-loss days from training or matches) per 1000 hours of player exposure in players belonging to coaches in the intervention group versus 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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Elisabeth Bandak, PhD, The Parker Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APPI2-MSK-2025-KNIPS_2.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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