- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03309904
Sport Without Injury ProgrammE Floorball (SWIPE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a cluster-randomized controlled trial including male and female youth (12-17 years) floorball players. Club is used as cluster unit.
Coaches in the intervention group receive education of the preventive neuromuscular training program Knee Control (Knäkontroll) before the start of the season. Knee Control consists of 6 different exercises, with 4 different variations and 1 pair-exercise, and takes about 10 minutes to complete. In addition, coaches are instructed to perform a 5-minute running warm-up before the Knee Control exercises. Teams are to carry out the intervention at all training sessions, and the 5-minute warm-up also before all matches.
Coaches in the control group carry on their normal training and warm-up routines with their clubs.
Teams are followed for one full season: October 2017 - March 2018. Data registered for the study include exposure to floorball training and matches, and injuries that occur as a result of participation in floorball.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Linköping, Sweden, 58183
- Linköping University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Teams with players 12-17 years of age (born 2000-2005)
- Teams who have not used a structured training program aiming to prevent injuries (the Knee Control or similar program) on a regular basis the last year
- Teams who have training at least twice per week
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Knee Control training program
The Knee Control program is a neuromuscular training program that consists of 6 different exercises, with 4 levels of progression and one pair-exercise, for each exercise.
The Knee Control program takes about 10 minute to complete after familiarization.
In addition, a 5-minute running warm-up is instructed to coaches.
Coaches are to perform the Knee Control program + the 5 minute warm-up at all training sessions during the season, and the 5 minute warm-up before all matches.
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10-minute training program to be performed at all team training sessions during the season.
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No Intervention: Control group - usual training
The control group teams receive no intervention, and coaches are instructed to carry out their normal training and warm-up practice throughout the season.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All physical complaints injury
Time Frame: Study start up to end of season (6 months)
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Any floorball related injury regardless of need of care or absence from floorball training or matches ("all physical complaints" injury definition)
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Study start up to end of season (6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-loss injury
Time Frame: Study start up to end of season (6 months)
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Floorball related injury causing absence from the next training or match with the team ("time-loss injury")
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Study start up to end of season (6 months)
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Medical attention injury
Time Frame: Study start up to end of season (6 months)
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Floorball related injury requiring the player to seek care ("medical attention injury")
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Study start up to end of season (6 months)
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Adverse events
Time Frame: Study start up to end of season (6 months)
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Adverse events of using the program (intervention group only)
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Study start up to end of season (6 months)
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Intervention compliance and fidelity
Time Frame: Study start up to end of season (6 months)
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Coach reported compliance and fidelity with the program protocol (intervention group only)
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Study start up to end of season (6 months)
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Coach experience of injuries and intervention program
Time Frame: Baseline and 6 months
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Coach baseline and follow-up experiences of injuries (control group and intervention group) and of the Knee Control program (intervention group only)
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Baseline and 6 months
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Player experience of injuries and intervention program
Time Frame: Baseline and 6 months
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Player baseline and follow-up experiences of injuries (control group and intervention group) and of the Knee Control program (intervention group only)
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Baseline and 6 months
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Exercise fidelity
Time Frame: At approximately 2 months and 5 months
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Exercise fidelity (observation of the technique when using the intervention in select intervention group teams)
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At approximately 2 months and 5 months
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Health care need
Time Frame: After study end at 6 months
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Number of health care visits due to floorball related injuries during the season, type of diagnostic examinations and treatments
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After study end at 6 months
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Costs
Time Frame: After study end at 6 months
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Estimated costs of floorball related injuries and costs of the intervention
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After study end at 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Hägglund, PhD, Linkoeping University
Publications and helpful links
General Publications
- Perera NKP, Walden M, Lindblom H, Akerlund I, Sonesson S, Hagglund M. Illness prevalence and symptoms in youth floorball players: a one-season prospective cohort study involving 471 players. BMJ Open. 2021 Dec 14;11(12):e051902. doi: 10.1136/bmjopen-2021-051902.
- Akerlund I, Walden M, Sonesson S, Hagglund M. Forty-five per cent lower acute injury incidence but no effect on overuse injury prevalence in youth floorball players (aged 12-17 years) who used an injury prevention exercise programme: two-armed parallel-group cluster randomised controlled trial. Br J Sports Med. 2020 Sep;54(17):1028-1035. doi: 10.1136/bjsports-2019-101295. Epub 2020 Jan 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHägglund SWIPE Floorball
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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