Trial record 1 of 137 for:    Repetitive Motion Disorders
Previous Study | Return to List | Next Study

Knowledge of Predicting Increased Risk for an Overuse Injury in Runners

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Northern Orthopaedic Division, Denmark
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01979562
First received: November 4, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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
Overuse Injuries
Musculoskeletal Make-up in the Lower Extremities

Study Type: Observational [Patient Registry]
Study Design: 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

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Injury defined as inappropriate musculoskeletal make-up in the lower extremities [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of kilometres spent on running each week [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Bone contact forces on the distal tibia during the stance phase of running [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Running pace, previous injuries and pain-relieving medication [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
100 runners
Male runners between 18-60 years.

Detailed Description:

The running style and the training composition and the body composition are thought to have a 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. Until now, no research shows the possible relation between the body composition such as the mutual length and width of femur and tibia and the development of overuse injuries.

Therefore, the aim of this study is to achieve evidence-based knowledge about these factors in order to advice runners about the precautions and to avoid that people get a sedentary lifestyle.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

100 male runners from athletic associations in Northern Jutland.

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
  • The runner has had an injury in the lower extremities within 3 months before baseline
  • The runner uses insoles or he has been through a surgical procedure in his 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
  • Unwillingness to cooperate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979562

Contacts
Contact: Rene B. Korsgaard, M.Sc. rkb@hst.aau.dk
Contact: Sten Rasmussen, M.D. 25520462 ext 45 sten.rasmussen@rn.dk

Locations
Denmark
Orthopaedic Surgery Research Unit, Aalborg University Hospital Not yet recruiting
Aalborg, Northern Jutland, Denmark, 9000
Contact: Rene B. Korsgaard, M.Sc.       rkb@hst.aau.dk   
Contact: Sten Rasmussen, M.D.    25520462 ext 45    sten.rasmussen@rn.dk   
Principal Investigator: Rene B. Korsgaard, M.Sc.         
Sub-Investigator: Sten Rasmussen, M.D.         
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
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. Department of Public Health, Aarhus University
Study Chair: Uffe Læssoe, Ass. prof. University College, Northern Jutland, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01979562     History of Changes
Other Study ID Numbers: N-20130074
Study First Received: November 4, 2013
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Overuse injury
Femur
Tibia
Running
Prevention

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Wounds and Injuries
Sprains and Strains

ClinicalTrials.gov processed this record on July 22, 2014