Clinical trial NCT01979562: Knowledge of Predicting Increased Risk for an Overuse Injury in Runners
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overuse Injuries
Musculoskeletal Make-up in the Lower Extremities
Keywords: Overuse injury
Femur
Tibia
Running
Prevention
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 male runners from athletic associations in Northern Jutland.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Injury defined as inappropriate musculoskeletal make-up in the lower extremities
timeFrame: 1 year
Secondary outcomes:
measure: Number of kilometres spent on running each week
timeFrame: 1 year
measure: Bone contact forces on the distal tibia during the stance phase of running
timeFrame: 1 year
Other outcomes:
measure: Running pace, previous injuries and pain-relieving medication
timeFrame: 1 year
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Surgery Research Unit, Aalborg University Hospital
state: Northern Jutland
Study officials:
affiliation: Aalborg University
name: Rene B. Korsgaard, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.
role: STUDY_DIRECTOR
affiliation: Center for Motor-Sensory Interaction, Aalborg University
name: Michael Voigt, Prof., PhD
role: STUDY_CHAIR
affiliation: Aalborg University
name: Uwe Kersting, Ass.prof.
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Rasmus O. Nielsen, M.Sc.
role: STUDY_CHAIR
affiliation: University College, Northern Jutland, Denmark
name: Uffe Læssoe, Ass. prof.
role: STUDY_CHAIR
References: