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Knowledge of Predicting Increased Risk for an Overuse Injury in Runners

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date November 4, 2013
First Posted Date November 8, 2013
Last Update Posted Date May 29, 2015
Study Start Date March 2014
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2013)
Injury defined as inappropriate musculoskeletal make-up in the lower extremities [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 7, 2013)
  • Number of kilometres spent on running each week [ Time Frame: 1 year ]
  • Bone contact forces on the distal tibia during the stance phase of running [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 7, 2013)
Running pace, previous injuries and pain-relieving medication [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 100 male runners from athletic associations in Northern Jutland.
Condition
  • Overuse Injuries
  • Musculoskeletal Make-up in the Lower Extremities
Intervention Not Provided
Study Groups/Cohorts 100 runners
Male runners between 18-60 years.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 7, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01979562
Other Study ID Numbers N-20130074
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Northern Orthopaedic Division, Denmark
Study Sponsor Northern Orthopaedic Division, Denmark
Collaborators Not Provided
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
PRS Account Northern Orthopaedic Division, Denmark
Verification Date May 2015