NCT03671395

Brief Summary

This study aims to prospectively investigate the relationship between a number of clinical and biomechanical variables and running-related injuries among a group of novice and recreational runners over a two year time period. To date, the incidence of running injuries among runners is high, with a lack of prospective research investigating the factors related to injury. It is thought that loading in excess of the tissues capabilities may be be a contributing factor to sustaining a running related injury. As such, this study hypothesizes that biomechanical factors may be related to injury. Healthy participants will perform a battery of clinical tests at baseline, as well as completing a survey that details their injury history and training habits. Kinematic and kinetic motion analysis will be used as participants perform a series of functional movements and a treadmill run. Enrolled participants will be monitored for the occurrence of running-related injuries via email for the duration of the study.

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
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

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

Study Start

First participant enrolled

February 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

May 2, 2018

Last Update Submit

July 21, 2020

Conditions

Keywords

Running InjuriesMotion AnalysisBiomechanicsInertial Measurement UnitSensor TechnologyKineticKinematicInjury

Outcome Measures

Primary Outcomes (3)

  • The occurrence of a running-related injury

    Participants will be followed up on a 6 week basis via email. A running-related injury will be defined as any muscle, bone, tendon or ligament pain in the lower back, hip, groin, thigh, leg, knee, foot, ankle and toe that caused the participant to stop or restrict their running. The pain must last for at least 7 days or 3 consecutive scheduled training sessions, or require the participant to consult a physician or other health care professional.

    6 week intervals from enrollment in the study, up to the total study time period of 2 years.

  • Peak loading (N/s) during running and jumping movements.

    This data will be derived from the inertial measurement units (Shimmer, Dublin, Ireland) attached to the legs and pelvis and using forceplate data (AMTI, Watertown, USA).

    One two hour session on day one of enrollment into the study.

  • Rate of loading (N/s2) during running.

    This data will be derived from the inertial measurement units (Shimmer, Dublin, Ireland) attached to the legs and pelvis and using forceplate data (AMTI, Watertown, USA).

    One two hour session on day one of enrollment into the study

Secondary Outcomes (6)

  • Peak range of motion (degrees) at the knee, hip and ankle during running.

    During a 15 minute run during one two hour session on day 1 of enrollment into the study.

  • Injury history in the past 2 years.

    10 minute questionnaire on day one of enrollment into the study.

  • Training history- type

    10 minute questionnaire on day one of enrollment into the study.

  • Training history-frequency

    10 minute questionnaire on day one of enrollment into the study.

  • Training history- mileage

    10 minute questionnaire on day one of enrollment into the study.

  • +1 more secondary outcomes

Other Outcomes (10)

  • Foot Posture Index (Scale, scoring from -12 to +12)

    Measured during a single two hour session on day one of enrollment into the study.

  • Navicular drop (mm)

    Measured during a single two hour session on day one of enrollment into the study.

  • Hip internal and external rotation range (degrees)

    One two hour session on day one of enrollment into the study.

  • +7 more other outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Novice and recreation runners.

You may qualify if:

  • Runners aged 18-65
  • Run minimum once per week

You may not qualify if:

  • No lower limb injury within the last three months
  • An injury will be defined as:
  • Any muscle, bone, tendon or ligament pain in the lower back, hip, groin, thigh, leg, knee, foot, ankle and toe that caused the participant to stop or restrict their running.
  • The pain must last for at least 7 days or 3 consecutive scheduled training sessions, or require the participant to consult a physician or other health care professional.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dublin City University

Dublin, Leinster, D09 Y5N0, Ireland

Location

Related Publications (7)

  • Bredeweg SW, Kluitenberg B, Bessem B, Buist I. Differences in kinetic variables between injured and noninjured novice runners: a prospective cohort study. J Sci Med Sport. 2013 May;16(3):205-10. doi: 10.1016/j.jsams.2012.08.002. Epub 2012 Aug 24.

    PMID: 22921763BACKGROUND
  • Buist I, Bredeweg SW, Lemmink KA, van Mechelen W, Diercks RL. Predictors of running-related injuries in novice runners enrolled in a systematic training program: a prospective cohort study. Am J Sports Med. 2010 Feb;38(2):273-80. doi: 10.1177/0363546509347985. Epub 2009 Dec 4.

    PMID: 19966104BACKGROUND
  • Ghani Zadeh Hesar N, Van Ginckel A, Cools A, Peersman W, Roosen P, De Clercq D, Witvrouw E. A prospective study on gait-related intrinsic risk factors for lower leg overuse injuries. Br J Sports Med. 2009 Dec;43(13):1057-61. doi: 10.1136/bjsm.2008.055723. Epub 2009 Feb 18.

    PMID: 19228665BACKGROUND
  • Hespanhol Junior LC, Pena Costa LO, Lopes AD. Previous injuries and some training characteristics predict running-related injuries in recreational runners: a prospective cohort study. J Physiother. 2013 Dec;59(4):263-9. doi: 10.1016/S1836-9553(13)70203-0.

    PMID: 24287220BACKGROUND
  • Lun V, Meeuwisse WH, Stergiou P, Stefanyshyn D. Relation between running injury and static lower limb alignment in recreational runners. Br J Sports Med. 2004 Oct;38(5):576-80. doi: 10.1136/bjsm.2003.005488.

    PMID: 15388542BACKGROUND
  • Malisoux L, Nielsen RO, Urhausen A, Theisen D. A step towards understanding the mechanisms of running-related injuries. J Sci Med Sport. 2015 Sep;18(5):523-8. doi: 10.1016/j.jsams.2014.07.014. Epub 2014 Aug 12.

    PMID: 25174773BACKGROUND
  • Nielsen RO, Buist I, Parner ET, Nohr EA, Sorensen H, Lind M, Rasmussen S. Predictors of Running-Related Injuries Among 930 Novice Runners: A 1-Year Prospective Follow-up Study. Orthop J Sports Med. 2013 May 2;1(1):2325967113487316. doi: 10.1177/2325967113487316. eCollection 2013 Jan-Jun.

    PMID: 26535228BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Aoife Burke

    Dublin City University, Insight Centre for Data Analytics

    PRINCIPAL INVESTIGATOR
  • Sarah Dillon

    Dublin City University, Insight Centre for Data Analytics

    PRINCIPAL INVESTIGATOR
  • Dr Kieran Moran

    Dublin City University, Insight Centre for Data Analytics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

September 14, 2018

Study Start

February 1, 2018

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations