NCT01979562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

November 4, 2013

Last Update Submit

May 28, 2015

Conditions

Keywords

Overuse injuryFemurTibiaRunningPrevention

Outcome Measures

Primary Outcomes (1)

  • Injury defined as inappropriate musculoskeletal make-up in the lower extremities

    1 year

Secondary Outcomes (2)

  • Number of kilometres spent on running each week

    1 year

  • Bone contact forces on the distal tibia during the stance phase of running

    1 year

Other Outcomes (1)

  • Running pace, previous injuries and pain-relieving medication

    1 year

Study Arms (1)

100 runners

Male runners between 18-60 years.

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 male runners from athletic associations in Northern Jutland.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, Northern Jutland, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Rene B. Korsgaard, M.Sc.

    Aalborg University

    PRINCIPAL INVESTIGATOR
  • Sten Rasmussen, M.D.

    Orthopaedic Research Unit, Aalborg University Hospital, Denmark

    STUDY DIRECTOR
  • 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

    STUDY CHAIR

Central Study Contacts

Rene B. Korsgaard, M.Sc.

CONTACT

Sten Rasmussen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 8, 2013

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations