Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Injury Prevention Exercises on Performance and Neuromuscular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251404
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
The Swedish Research Council
Region Östergötland
Information provided by (Responsible Party):
Martin Hägglund, Linkoeping University

Brief 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 on a newly developed exercise program.

Condition or disease Intervention/treatment Phase
Sport Injury Adherence, Patient Other: Injury prevention exercise programs Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-armed cluster randomized parallel trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors (performance tests and neuromuscular function) blinded to group allocation
Primary Purpose: Prevention
Official Title: Effects of Two Injury Prevention Exercise Programs on Performance and Neuromuscular Function in Youth Football
Actual Study Start Date : August 19, 2017
Actual Primary Completion Date : November 26, 2017
Actual Study Completion Date : November 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in performance on the agility t-test (s) [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Change in performance on the single-leg hop for distance (m) [ Time Frame: Baseline and 12 weeks ]
  2. Change in performance on drop vertical jumps as measured with knee separation distance (m) [ Time Frame: Baseline and 12 weeks ]
  3. Change in performance on the 505 agility test (s) [ Time Frame: Baseline and 12 weeks ]
  4. Change in performance on the side-hop test (n) [ Time Frame: Baseline and 12 weeks ]
  5. Change in performance on the 10 m sprint test (s) [ Time Frame: Baseline and 12 weeks ]
  6. Change in performance on the 20 m sprint test (s) [ Time Frame: Baseline and 12 weeks ]
  7. Change in performance on evaluation of lower extremity landing technique during the tuck jump test (points) [ Time Frame: Baseline and 12 weeks ]
  8. Coach baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs [ Time Frame: Baseline and 12 weeks ]
  9. Coach reported compliance and fidelity with the program protocol [ Time Frame: At follow-up 12 weeks ]
  10. Player baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs [ Time Frame: Baseline and 12 weeks ]
  11. Injuries that occur during the intervention period (number of injured players in each group) [ Time Frame: At follow-up 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251404


Locations
Layout table for location information
Sweden
Division of physiotherapy, Department of Medical and Health Sciences, Linköping University
Linköping, Sweden, 58183
Sponsors and Collaborators
Linkoeping University
The Swedish Research Council
Region Östergötland
Investigators
Layout table for investigator information
Principal Investigator: Martin Hägglund, PhD Linkoeping University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Martin Hägglund, Associate professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT03251404    
Other Study ID Numbers: MHägglundPerformance
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study data (de-identified player performance test scores) may be available at request from the principal investigator

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Athletic Injuries