Effects of Injury Prevention Exercises on Performance and Neuromuscular Function

February 26, 2018 updated by: Martin Hägglund, Linkoeping University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 58183
        • Division of physiotherapy, Department of Medical and Health Sciences, Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Football teams who have training at least twice per week
  • Healthy players who can exert themselves maximally during testing

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Knee Control original
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.
Other: Injury prevention exercise programs
The two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function.
Experimental: Knee Control+
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.
Other: Injury prevention exercise programs
The two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in performance on the agility t-test (s)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in performance on the single-leg hop for distance (m)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in performance on drop vertical jumps as measured with knee separation distance (m)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in performance on the 505 agility test (s)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in performance on the side-hop test (n)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in performance on the 10 m sprint test (s)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in performance on the 20 m sprint test (s)
Time Frame: Baseline and 12 weeks
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
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
Baseline and 12 weeks
Coach reported compliance and fidelity with the program protocol
Time Frame: At follow-up 12 weeks
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
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
At follow-up 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Swedish Research Council
Region Östergötland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Hägglund, PhD, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MHägglundPerformance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Study data (de-identified player performance test scores) may be available at request from the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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