Knowledge of Predicting Increased Risk for an Overuse Injury in Runners

Overuse Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979562
• Other study ID #: N-20130074
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2013
• Last updated: May 28, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: Rene B. Korsgaard, M.Sc.
• Email: rkb[@]hst.aau.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Musculoskeletal Make-up in the Lower Extremities
• Overuse Injuries

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aalborg University Hospital	Aalborg	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Running pace, previous injuries and pain-relieving medication		1 year	Yes
Primary	Injury defined as inappropriate musculoskeletal make-up in the lower extremities		1 year	Yes
Secondary	Number of kilometres spent on running each week		1 year	Yes
Secondary	Bone contact forces on the distal tibia during the stance phase of running		1 year	Yes