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Knowledge of Predicting Increased Risk for an Overuse Injury in Runners

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. Identifier: NCT01979562
Recruitment Status : Unknown
Verified May 2015 by Northern Orthopaedic Division, Denmark.
Recruitment status was:  Recruiting
First Posted : November 8, 2013
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:
The purpose of this study is to examine the skeleton of the legs and the running style in order to predict a possible overuse injury.

Condition or disease
Overuse Injuries Musculoskeletal Make-up in the Lower Extremities

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: 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 Start Date : March 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

100 runners
Male runners between 18-60 years.

Primary Outcome Measures :
  1. Injury defined as inappropriate musculoskeletal make-up in the lower extremities [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of kilometres spent on running each week [ Time Frame: 1 year ]
  2. Bone contact forces on the distal tibia during the stance phase of running [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Running pace, previous injuries and pain-relieving medication [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 male runners from athletic associations in Northern Jutland.

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

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 identifier (NCT number): NCT01979562

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Contact: Rene B. Korsgaard, M.Sc.
Contact: Sten Rasmussen, M.D. 25520462 ext 45

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Orthopaedic Surgery Research Unit, Aalborg University Hospital Recruiting
Aalborg, Northern Jutland, Denmark, 9000
Contact: Rene B. Korsgaard, M.Sc.   
Contact: Sten Rasmussen, M.D.    25520462 ext 45   
Principal Investigator: Rene B. Korsgaard, M.Sc.         
Sub-Investigator: Sten Rasmussen, M.D.         
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
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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, Aalborg University
Study Chair: Rasmus O. Nielsen, M.Sc. University of Aarhus
Study Chair: Uffe Læssoe, Ass. prof. University College, Northern Jutland, Denmark

Additional Information:

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Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT01979562    
Other Study ID Numbers: N-20130074
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Northern Orthopaedic Division, Denmark:
Overuse injury
Additional relevant MeSH terms:
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Cumulative Trauma Disorders
Wounds and Injuries
Sprains and Strains