- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03408925
Preventing Injury in Elite Orienteerers
Preventing Lower Extremity Injury in Elite Orienteerers
Study Overview
Detailed Description
The high physical load associated with running through uneven terrain contributes to that orienteerers are exposed to high injury risk, where the majority of injuries located in the lower extremities. Specific training programmes have been effective at reducing injury risk in sports. Yet, not trial has been conducted in elite orienteering. The aim of this study is to investigate the effect a specific exercise program on the incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are allocated to an intervention or control group. The intervention group performs four specific exercises, with three difficult levels intensified every second week over the first four weeks, targeting strength, flexibility and coordination of the lower extremity. The exercises are completed four times a week (10 minutes per session) in conjunction with normal training. Injury data are collected every second week using valid injury questionnaire distributed by text messages over 14 weeks. Primary outcome is number of substantial injuries in the lower extremity. Secondary outcomes are incidence of ankle sprains and the average substantial injury prevalence across the 10 weeks. Participants will be recruited in January-February 2018. The intervention starts in February 2018 and data collection will be completed in June 2018. Data analyses are expected to be completed in October-November 2018.
Due to high injury risk and lack of injury prevention trials in orienteering, a RCT investigating the effect of a specific exercise program on the incidence of injuries in the lower extremity, is warranted. The results of this trial will be beneficial to orienteerers, clubs, federations and increase our understanding on how lower extremity injuries can be prevented in a physically challenging sport.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Huddinge, Sweden, 141 52
- Karolinska Institutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adult elite orienteerers Aged 18-40 years Participating in the highest national orienteering league (Swedish League) Participant inclusion criteria - Age group: Adult Participant inclusion criteria - Gender: Both
Exclusion Criteria:
Injured adult elite orienteerers not able to perform baseline tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
The intervention consists of an exercise program developed by the medical team of the National Federation of Orienteering.
Specifically, it consists of four exercises targeting strength, flexibility and coordination of the lower extremity.
The orienteerers are asked to perform the exercises four times a week throughout the entire study period.
The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function (online supplement).
Each second week the exercises' difficulty level is increased.
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The orienteerers are asked to perform specific exercises four times a week throughout the entire study period.
The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function.
Each second week the exercises' difficulty level is increased.
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No Intervention: Control
Normal training, no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lower extremity injury
Time Frame: March-June 2018 (10 weeks)
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Number of substantial injuries in the lower extremity
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March-June 2018 (10 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ankle sprain
Time Frame: March-June 2018 (10 weeks)
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Incidence of ankle sprains injuries
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March-June 2018 (10 weeks)
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Substantial injury
Time Frame: March-June 2018 (10 weeks)
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The average substantial injury prevalence
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March-June 2018 (10 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Philip von Rosen, Karolinska Insitute
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-1645/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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