Sport InjuryNCT03251404
Effects of Injury Prevention Exercises on Performance and Neuromuscular Function
A study testing Injury prevention exercise programs in people with Sport Injury and Adherence, Patient, run by Linkoeping University at 1 site in Sweden.
Trial summary
This study evaluates the effects of two different injury prevention exercise programs on sports-relevant performance tests and neuromuscular function in youth football players. Half of participants will receive education on an existing and previously tested exercise program, while the other half will receive education… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Adherence, Patient
- What is being tested?
- Injury prevention exercise programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSweden
- Study dates
- 19 Aug 2017to 26 Nov 2017
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Football teams who have training at least twice per week
- Healthy players who can exert themselves maximally during testing
Who cannot join
- Teams who have used the Knee Control or a similar injury prevention exercise program on a regular basis the last year
- Players who cannot take full part in measurements due to illnesses or injuries
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division of physiotherapy, Department of Medical and Health Sciences, Linköping University
Linköping, 58183
About this study
Official title: Effects of Two Injury Prevention Exercise Programs on Performance and Neuromuscular Function in Youth Football
This study evaluates the effects of two different injury prevention exercise programs on sports-relevant performance tests and neuromuscular function in youth football players. Half of participants will receive education on an existing and previously tested exercise program, while the other half will receive education on a newly developed exercise program.
Read the detailed description
Injury prevention exercise programs have been developed for a variety of sporting contexts and many have proven to be efficacious in preventing injuries. Adherence with the training may, however, be an issue and poor adherence may limit the preventive effect. If using the preventive exercise programs can be shown to improve sports-relevant performance this may motivate both coaches and players to use these programs, since the reduction in injury risk is harder to notice for the individual.
This study focuses on a Swedish injury prevention exercise program called Knee Control. The program has been found efficacious in preventing acute knee injuries in girls' adolescent football players in previous trials. We have found, however, that coaches often modify the Knee Control program to improve program fit and player buy-in among female youth football players. Careful changes must be made to the program since there is a risk of compromising the preventive effect and the effect on performance if the training dose is too low or if effective exercises are replaced with other exercises. We have therefore further developed the Knee Control program, to a Knee Control+ program, to support the coaches in the tailoring of the program to preserve the preventive effect and hopefully enhance performance effects. By introducing more variation with easier and more difficult exercises, pair-exercises, competitive and plyometric elements the new Knee Control+ program may better fit both the youngest and the oldest players, which in turn may facilitate fidelity with and maintenance of the program.
The aim of the study is to compare the neuromuscular and performance effects of the original Knee Control and the new Knee Control+ programs among youth female and male football players. A secondary aim is to study player and coach experiences of the programs and their fidelity with the training protocol.
Hypothesis: We expect similar effects of both programs, or superior effects of the Knee Control+ program, showing that the programs are compatible but the program adherence and fidelity being better with Knee Control+.
Methods: Eight youth football teams (4 boys, 4 girls, age 13-17 years) with approximately 120 players will be included in the study. Four teams will receive education about the Knee Control program and four teams about the Knee Control+ program. All coaches and two to three players per team will take part in a workshop at baseline where registered physiotherapists will give practical instructions of the intervention exercise programs. The workshops will also contain theoretical information about injuries in football and the background for either the Knee Control or the Knee Control+ programs. The attending coaches and players will be able to test all exercises and receive feedback about correct movement technique.
Outcomes: Football-relevant performance and neuromuscular function will be tested at baseline and after 12 weeks of training.
- Conditions
- Sport Injury, Adherence, Patient
- Being tested
- Injury prevention exercise programs
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury prevention exercise programsOther
The two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function.
| Study group | Role | What they receive |
|---|---|---|
| Knee Control original | Active comparator | The Knee Control program exercise program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period. Receives: Other: Injury prevention exercise programs |
| Knee Control+ | Experimental | The Knee Control+ is an extension of the original Knee Control exercise program offering a wider selection of exercises (to increase adherence) and more physically challenging exercises (adapted for athletes in the late teens and provide further stimuli to increase player performance and neuromuscular function). The program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period. Receives: Other: Injury prevention exercise programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on the agility t-test (s)
Measured: Baseline and 12 weeks
Secondary outcomes (11)
Change in performance on the single-leg hop for distance (m)
Measured: Baseline and 12 weeks
Change in performance on drop vertical jumps as measured with knee separation distance (m)
Measured: Baseline and 12 weeks
Change in performance on the 505 agility test (s)
Measured: Baseline and 12 weeks
Change in performance on the side-hop test (n)
Measured: Baseline and 12 weeks
Change in performance on the 10 m sprint test (s)
Measured: Baseline and 12 weeks
Change in performance on the 20 m sprint test (s)
Measured: Baseline and 12 weeks
Change in performance on evaluation of lower extremity landing technique during the tuck jump test (points)
Measured: Baseline and 12 weeks
Coach baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs
Measured: Baseline and 12 weeks
Coach reported compliance and fidelity with the program protocol
Measured: At follow-up 12 weeks
Player baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs
Measured: Baseline and 12 weeks
Injuries that occur during the intervention period (number of injured players in each group)
Measured: At follow-up 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start19 Aug 2017
- Primary completion26 Nov 2017
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sport InjuryStudies 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
- Two-armed cluster randomized parallel trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- The Swedish Research Council, Region Östergötland
- Responsible party
- Principal investigator, Martin Hägglund, Linkoeping University
- Investigators
- Martin Hägglund, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251404
- Sponsor's protocol ID
- MHägglundPerformance
- Status last verified
- Feb 2018
- First submitted
- 13 Aug 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study data (de-identified player performance test scores) may be available at request from the principal investigator
Publications
Lindblom H, Walden M, Hagglund M. Performance Effects with Injury Prevention Exercise Programmes in Male Youth Football Players: A Randomised Trial Comparing Two Interventions. Sports Med Open. 2020 Nov 23;6(1):56. doi: 10.1186/s40798-020-00282-7.
PubMed 33226542Sonesson S, Lindblom H, Hagglund M. Performance on sprint, agility and jump tests have moderate to strong correlations in youth football players but performance tests are weakly correlated to neuromuscular control tests. Knee Surg Sports Traumatol Arthrosc. 2021 May;29(5):1659-1669. doi: 10.1007/s00167-020-06302-z. Epub 2020 Oct 8.
PubMed 33030610Lindblom H, Walden M, Carlfjord S, Hagglund M. Limited positive effects on jump-landing technique in girls but not in boys after 8 weeks of injury prevention exercise training in youth football. Knee Surg Sports Traumatol Arthrosc. 2020 Feb;28(2):528-537. doi: 10.1007/s00167-019-05721-x. Epub 2019 Sep 20.
PubMed 31541293
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Injury Prevention Exercise Programs on Performance and Neuromuscular Function in Youth Football
- ClinicalTrials.gov ID
- NCT03251404
- Acronym / sponsor ID
- MHägglundPerformance
- Conditions
- Sport Injury, Adherence, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- The Swedish Research Council, Region Östergötland
- Study start
- 19 Aug 2017 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 16 Aug 2017 (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.
This study evaluates the effects of two different injury prevention exercise programs on sports-relevant performance tests and neuromuscular function in youth football players. Half of participants will receive education on an existing and previously tested exercise program, while the other half will receive education on a newly developed exercise program.
Detailed description
Injury prevention exercise programs have been developed for a variety of sporting contexts and many have proven to be efficacious in preventing injuries. Adherence with the training may, however, be an issue and poor adherence may limit the preventive effect. If using the preventive exercise programs can be shown to improve sports-relevant performance this may motivate both coaches and players to use these programs, since the reduction in injury risk is harder to notice for the individual.
This study focuses on a Swedish injury prevention exercise program called Knee Control. The program has been found efficacious in preventing acute knee injuries in girls' adolescent football players in previous trials. We have found, however, that coaches often modify the Knee Control program to improve program fit and player buy-in among female youth football players. Careful changes must be made to the program since there is a risk of compromising the preventive effect and the effect on performance if the training dose is too low or if effective exercises are replaced with other exercises. We have therefore further developed the Knee Control program, to a Knee Control+ program, to support the coaches in the tailoring of the program to preserve the preventive effect and hopefully enhance performance effects. By introducing more variation with easier and more difficult exercises, pair-exercises, competitive and plyometric elements the new Knee Control+ program may better fit both the youngest and the oldest players, which in turn may facilitate fidelity with and maintenance of the program.
The aim of the study is to compare the neuromuscular and performance effects of the original Knee Control and the new Knee Control+ programs among youth female and male football players. A secondary aim is to study player and coach experiences of the programs and their fidelity with the training protocol.
Hypothesis: We expect similar effects of both programs, or superior effects of the Knee Control+ program, showing that the programs are compatible but the program adherence and fidelity being better with Knee Control+.
Methods: Eight youth football teams (4 boys, 4 girls, age 13-17 years) with approximately 120 players will be included in the study. Four teams will receive education about the Knee Control program and four teams about the Knee Control+ program. All coaches and two to three players per team will take part in a workshop at baseline where registered physiotherapists will give practical instructions of the intervention exercise programs. The workshops will also contain theoretical information about injuries in football and the background for either the Knee Control or the Knee Control+ programs. The attending coaches and players will be able to test all exercises and receive feedback about correct movement technique.
Outcomes: Football-relevant performance and neuromuscular function will be tested at baseline and after 12 weeks of training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-armed cluster randomized parallel trial
| Arm | Type | Receives |
|---|---|---|
| Knee Control original | Active comparator | Other: Injury prevention exercise programsThe Knee Control program exercise program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period. |
| Knee Control+ | Experimental | Other: Injury prevention exercise programsThe Knee Control+ is an extension of the original Knee Control exercise program offering a wider selection of exercises (to increase adherence) and more physically challenging exercises (adapted for athletes in the late teens and provide further stimuli to increase player performance and neuromuscular function). The program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Football teams who have training at least twice per week
- Healthy players who can exert themselves maximally during testing
Key exclusion criteria (2 listed)
- Teams who have used the Knee Control or a similar injury prevention exercise program on a regular basis the last year
- Players who cannot take full part in measurements due to illnesses or injuries
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 exercise programsThe two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function. | Other | Knee Control original, Knee Control+ |
Primary outcome
Change in performance on the agility t-test (s)
Time frame: Baseline and 12 weeks
11 secondary outcomes
Change in performance on the single-leg hop for distance (m)
Time frame: Baseline and 12 weeks
Change in performance on drop vertical jumps as measured with knee separation distance (m)
Time frame: Baseline and 12 weeks
Change in performance on the 505 agility test (s)
Time frame: Baseline and 12 weeks
Change in performance on the side-hop test (n)
Time frame: Baseline and 12 weeks
Change in performance on the 10 m sprint test (s)
Time frame: Baseline and 12 weeks
Change in performance on the 20 m sprint test (s)
Time frame: Baseline and 12 weeks
Change in performance on evaluation of lower extremity landing technique during the tuck jump test (points)
Time frame: Baseline and 12 weeks
Coach baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs
Time frame: Baseline and 12 weeks
Coach reported compliance and fidelity with the program protocol
Time frame: At follow-up 12 weeks
Player baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs
Time frame: Baseline and 12 weeks
Injuries that occur during the intervention period (number of injured players in each group)
Time frame: At follow-up 12 weeks
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 27 Feb 2018.
- Derived from this study: PubMed 33226542Lindblom H, Walden M, Hagglund M. Performance Effects with Injury Prevention Exercise Programmes in Male Youth Football Players: A Randomised Trial Comparing Two Interventions. Sports Med Open. 2020 Nov 23;6(1):56. doi: 10.1186/s40798-020-00282-7.
- Derived from this study: PubMed 33030610Sonesson S, Lindblom H, Hagglund M. Performance on sprint, agility and jump tests have moderate to strong correlations in youth football players but performance tests are weakly correlated to neuromuscular control tests. Knee Surg Sports Traumatol Arthrosc. 2021 May;29(5):1659-1669. doi: 10.1007/s00167-020-06302-z. Epub 2020 Oct 8.
- Derived from this study: PubMed 31541293Lindblom H, Walden M, Carlfjord S, Hagglund M. Limited positive effects on jump-landing technique in girls but not in boys after 8 weeks of injury prevention exercise training in youth football. Knee Surg Sports Traumatol Arthrosc. 2020 Feb;28(2):528-537. doi: 10.1007/s00167-019-05721-x. Epub 2019 Sep 20.
- Individual participant dataSharing planned: Undecided. Study data (de-identified player performance test scores) may be available at request from the principal investigator
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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.
Martin Hägglund, PhD principal investigator
Linkoeping University
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 exercise programs in people with Sport Injury and Adherence, Patient, run by Linkoeping University at 1 site in Sweden.
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 2 inclusion and 2 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 27 Feb 2018. 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 Sweden. 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?
Change in performance on the agility t-test (s) (time frame: Baseline and 12 weeks). 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 NCT03251404, which also lists 3 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 27 Feb 2018.