- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979562
Knowledge of Predicting Increased Risk for an Overuse Injury in Runners
Knowledge of Predicting Increased Risk for an Overuse Injury in Runners Related to the Mutual Length of Femur and Tibia and the Running Style
Study Overview
Status
Detailed Description
The running style and the training composition and the body composition are thought to have major effect on the development of overuse injuries.
To define a prevention strategy, one must have the knowledge about risk factors and causation. The training composition is very relevant clinically but the underlying factors have not been studied yet. For the present there is no scientifical evidence of a possible relation between the body composition such as the mutual length and width of femur and tibia and the development of overuse injuries.
Thus, the aim of this study is to achieve evidence-based knowledge of these factors in order to advice runners about the precautions and to avoid that people get a sedentary lifestyle.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rene B. Korsgaard, M.Sc.
- Email: rkb@hst.aau.dk
Study Locations
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Northern Jutland
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Aalborg, Northern Jutland, Denmark, 9000
- Recruiting
- Orthopaedic Surgery Research Unit, Aalborg University Hospital
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Sub-Investigator:
- Sten Rasmussen, M.D.
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Contact:
- Rene B. Korsgaard, M.Sc.
- Email: rkb@hst.aau.dk
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Principal Investigator:
- Rene B. Korsgaard, M.Sc.
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men between 18 and 60 years
- Access to an e-mail
- Two years running experience as a minimum
- Exercises three times weekly as a minimum, on annual average or until any excessive load on the body occurs
- Experience with running machines
- A written signed statement of consent
Exclusion Criteria:
- Lack of a written signed statement of consent
- Unwillingness to keep a journal during the running exercises
- Unwillingness to register data during the follow-up period
- Injury in the lower extremities within 3 months before baseline
- The runner uses insoles or he has been through a surgical procedure in the lower extremities
- A mental disability for example dementia or challenging behaviour
- The runner plays heavy sport, cf. American College of Sports Medicine
- Unability to read or understand Danish
- Unability to cooperate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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100 runners
Male runners between 18-60 years.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Injury defined as inappropriate musculoskeletal make-up in the lower extremities
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of kilometres spent on running each week
Time Frame: 1 year
|
1 year
|
Bone contact forces on the distal tibia during the stance phase of running
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Running pace, previous injuries and pain-relieving medication
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rene B. Korsgaard, M.Sc., Aalborg University
- Study Director: Sten Rasmussen, M.D., Orthopaedic Research Unit, Aalborg University Hospital, Denmark
- Study Chair: Michael Voigt, Prof., PhD, Center for Motor-Sensory Interaction, Aalborg University
- Study Chair: Uwe Kersting, Ass.prof., Aalborg University
- Study Chair: Rasmus O. Nielsen, M.Sc., University of Aarhus
- Study Chair: Uffe Læssoe, Ass. prof., University College, Northern Jutland, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
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
- N-20130074
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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