Knee InjuriesNCT06846008
The Effectiveness of a Coach-Focused Intervention on Preventing Knee Injuries in Amateur Football Players
A study testing Ahead of the Game and Usual Practice in people with Knee Injuries, run by Marius Henriksen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Ahead of the Game and Usual Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2025to 30 Jun 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Knee Injuries
- Being tested
- Ahead of the Game, Usual Practice
- Keywords
- knee injury, injury prevention training, football, coaches, players
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahead of the GameBehavioural
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 PracticeOther
Usual training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Usual Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Secondary outcomes (9)
Incidence of acute knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Incidence of acute minimal knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Incidence of acute mild knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Incidence of acute moderate knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Time-loss days of acute knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Time-loss days of acute minimal knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Time-loss days of acute mild knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Time-loss days of acute moderate knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Time-loss days of acute severe knee injuries
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.
Measured: From baseline to end of the intervention, 14 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start23 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Elisabeth Bandak, PhD, Study chair, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846008
- Sponsor's protocol ID
- APPI2-MSK-2025-KNIPS_2.0
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can upon rasonable request to the investigator be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Coach-Focused Intervention on Preventing Acute Severe Knee Injuries in Amateur Football Players: A Cluster Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT06846008
- Acronym / sponsor ID
- APPI2-MSK-2025-KNIPS_2.0
- Conditions
- Knee Injuries
- Keywords
- knee injury, injury prevention training, football, coaches, players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 23 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Feb 2025 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Usual PracticeUsual training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 ).
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 |
|---|---|---|
| Ahead of the GameEvidence-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. | Behavioural | – |
| Usual PracticeUsual training | Other | Usual practice |
Primary outcome
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.
9 secondary outcomes
Incidence of acute knee injuries
Time frame: 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.
Incidence of acute mild knee injuries
Time frame: 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.
Time-loss days of acute knee injuries
Time frame: 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.
Time-loss days of acute mild knee injuries
Time frame: 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.
Time-loss days of acute severe knee injuries
Time frame: From baseline to end of the intervention, 14 weeks after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No. IPD can upon rasonable request to the investigator be shared.
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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.
Elisabeth Bandak, PhD study chair
The Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ahead of the Game and Usual Practice in people with Knee Injuries, run by Marius Henriksen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of acute severe knee injuries in players. (time frame: From baseline to end of the intervention, 14 weeks after baseline.). 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 12 Aug 2025.