Injury PreventionNCT05137015
Preventing Injuries in Young Football Players
A study testing Injury prevention program in people with Injury Prevention, run by Universität des Saarlandes at 1 site in Kosovo.
Trial summary
Football is the most popular sport in the world, with 260 million male and female active participants, including ~113,000 FIFA registered professional players. Playing football is fun and can provide many health benefits, however, it also presents a high injury risk. Read more about this study
- Who is it for?
- Ages 13 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injury Prevention
- What is being tested?
- Injury prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,027 participants
- Where
- 1 siteKosovo
- Study dates
- 4 Sep 2021to 21 Jan 2023
- 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 13 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- officially registered football club in the football federation of Kosovo players must be between 13-19 years old regular training must take place at least three times per week
Who cannot join
- teams already using an injury prevention program injured players
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Injuries in Young Football Players: a Cluster Randomised Controlled Trial
Football is the most popular sport in the world, with 260 million male and female active participants, including ~113,000 FIFA registered professional players. Playing football is fun and can provide many health benefits, however, it also presents a high injury risk. Studies on elite and non-elite footballers have reported similar injury rates in both genders. The most common football-related injuries are the knee and ankle ligament and thigh muscle strains, Over the past two decades, significant advancement has been made in the field of injury prevention in football. There are used trials to prevent specific injuries, as ankle sprain, ACL injuries, hamstring strains, etc. On the other hand, there are created programs designed to prevent a wider spectrum of injuries like FIFA11+.
Therefore, the aim of this study is to investigate the effect of a new injury prevention program on the overall injury incidence in young football players.
- Conditions
- Injury Prevention
- Being tested
- Injury prevention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury prevention programOther
The execution of the program takes 10-15 minutes. The program will be performed in the training sessions, after the usual warm-up.
The program is based on scientific evidence that has previously shown good efficacy on injury prevention in football. The exercise categories address 7 aspects:
- Balance
- Core stability
- Hamstring eccentrics
- Glute activation
- Plyometrics
- Running
- Games The games are included with the aim to increase the attractiveness of the program.
Each category contains 2 exercises and the coach is free to decide which one to choose in every training session. All exercises are organized in five or six levels with increasing difficulty (physically and cognitively).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will use the new injury prevention program at least twice per week in their training sessions. Receives: Other: Injury prevention program |
| Control | No intervention | The control group will continue their usual training routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall injury rate
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start4 Sep 2021
- Primary completion29 May 2022
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Injury PreventionStudies 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
- Model description
- Cluster randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137015
- Sponsor's protocol ID
- Injury Prevention Study 21/22
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Obertinca R, Meha R, Hoxha I, Shabani B, Meyer T, Aus der Funten K. Impact of the 'FUNBALL' Programme on Severe Injuries Among Young Male Football Players: A Secondary Analysis from a Cluster-Randomised Controlled Trial. Sports Med Open. 2025 Nov 27;11(1):151. doi: 10.1186/s40798-025-00945-3.
PubMed 41310111Obertinca R, Meha R, Hoxha I, Shabani B, Meyer T, Aus der Funten K. Efficacy of a new injury prevention programme (FUNBALL) in young male football (soccer) players: a cluster-randomised controlled trial. Br J Sports Med. 2024 May 2;58(10):548-555. doi: 10.1136/bjsports-2023-107388.
PubMed 38499320
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Injuries in Young Football Players: a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05137015
- Acronym / sponsor ID
- Injury Prevention Study 21/22
- Conditions
- Injury Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 30 Nov 2021 (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.
Football is the most popular sport in the world, with 260 million male and female active participants, including ~113,000 FIFA registered professional players. Playing football is fun and can provide many health benefits, however, it also presents a high injury risk. Studies on elite and non-elite footballers have reported similar injury rates in both genders. The most common football-related injuries are the knee and ankle ligament and thigh muscle strains, Over the past two decades, significant advancement has been made in the field of injury prevention in football. There are used trials to prevent specific injuries, as ankle sprain, ACL injuries, hamstring strains, etc. On the other hand, there are created programs designed to prevent a wider spectrum of injuries like FIFA11+.
Therefore, the aim of this study is to investigate the effect of a new injury prevention program on the overall injury incidence in young football players.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Injury prevention programThe intervention group will use the new injury prevention program at least twice per week in their training sessions. |
| Control | No intervention | –The control group will continue their usual training routine. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- officially registered football club in the football federation of Kosovo players must be between 13-19 years old regular training must take place at least three times per week
Key exclusion criteria (1 listed)
- teams already using an injury prevention program injured players
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 |
|---|---|---|
| Injury prevention programThe execution of the program takes 10-15 minutes. The program will be performed in the training sessions, after the usual warm-up. The program is based on scientific evidence that has previously shown good efficacy on injury prevention in football. The exercise categories address 7 aspects: 1. Balance 2. Core stability 3. Hamstring eccentrics 4. Glute activation 5. Plyometrics 6. Running 7. Games The games are included with the aim to increase the attractiveness of the program. Each category contains 2 exercises and the coach is free to decide which one to choose in every training session. All exercises are organized in five or six levels with increasing difficulty (physically and cognitively). | Other | Intervention |
Primary outcome
Overall injury rate
Time frame: up to 9 months
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 20 Apr 2023.
- Derived from this study: PubMed 41310111Obertinca R, Meha R, Hoxha I, Shabani B, Meyer T, Aus der Funten K. Impact of the 'FUNBALL' Programme on Severe Injuries Among Young Male Football Players: A Secondary Analysis from a Cluster-Randomised Controlled Trial. Sports Med Open. 2025 Nov 27;11(1):151. doi: 10.1186/s40798-025-00945-3.
- Derived from this study: PubMed 38499320Obertinca R, Meha R, Hoxha I, Shabani B, Meyer T, Aus der Funten K. Efficacy of a new injury prevention programme (FUNBALL) in young male football (soccer) players: a cluster-randomised controlled trial. Br J Sports Med. 2024 May 2;58(10):548-555. doi: 10.1136/bjsports-2023-107388.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injury prevention program in people with Injury Prevention, run by Universität des Saarlandes at 1 site in Kosovo.
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 1 inclusion and 1 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 20 Apr 2023. 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 Kosovo. 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?
Overall injury rate (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137015, which also lists 2 linked publications.
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 20 Apr 2023.