The DCU Running Injury Surveillance Centre Study: A Prospective Investigation of Factors Relating to Running Injuries

Musculoskeletal Injury Clinical Trial

— DCU RISC  

Official title:

The DCU Running Injury Surveillance Centre (RISC) Study: A Prospective Investigation of Factors Relating to Running Injuries

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03671395
• Other study ID #: SFI12/RC/2289
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: May 2021

Study information

• Verified date: July 2020
• Source: Dublin City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Recruitment:

Novice and recreational runners will be recruited via emails, posters and social media. A novice runner is defined as a person who has not been running on a regular basis during the last year and completed ≤10km total training volume per week during the preceding year. A recreational runner will be defined as a person who runs a minimum of 10km per week, for at least six months prior to inclusion in the study.

Study Protocol:

Upon screening for inclusion and exclusion, participants will complete a baseline evaluation. This will consist of 1.) A survey, 2.) A battery of clinical tests and 3.) Motion analysis testing. A description of each component is detailed below.

1. Survey:

This survey will be self-reported by each participant. The aim of this survey is to detail each participants history of injuries and training habits. Questions are deigned based on previous survey designs relating to running injuries.

2. Battery of clinical tests:

The battery of physical performance tests will include: The foot posture index, the navicular drop, goniometry of the hip and ankle, dynamometry of the hip abductors, hip extensors, knee extensors, knee flexors and plantar flexors.

3. Motion analysis testing:

This will be broken into two components; a functional movement protocol and a treadmill run. During these components, motion will be tracked using wearable inertial sensors (Shimmer, Dublin, Ireland) and two forceplates (AMTI, Watertown, MA, USA). A 17-camera 3D motion analysis system (Vicon, Oxford, United Kingdom) will capture data at a sampling rate of 200 Hz. Reflective markers will be applied to the skin using specific anatomical landmarks to map their location. The functional movement protocol will consist of a series of jumping and landing movements, including double leg and single leg counter movement jumps, unilateral hopping, single leg drop landings and single leg drop jumps. Following this, participants will complete a run to fatigue. Motion analysis data will be captured at the end and start of this run. Fatigue will be determined by a reported rate of perceived exertion score of 17 (very hard) on the BORG Scale and a heart rate of 85% of the heart rate max, as determined by the Karvonen Formula (220-age).

Participants will then resume their normal training regime. Participants will be tracked for injuries via email over the course of the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 315
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Runners aged 18-65

• Run minimum once per week

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Musculoskeletal Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Ireland	Dublin City University	Dublin	Leinster

Sponsors (2)

Lead Sponsor	Collaborator
Dublin City University	Insight Centre for Data Analytics

Country where clinical trial is conducted

Ireland, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nielsen RO, Buist I, Parner ET, Nohr EA, Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Foot Posture Index (Scale, scoring from -12 to +12)	Measure of static foot position.	Measured during a single two hour session on day one of enrollment into the study.
Other	Navicular drop (mm)	Measure of dynamic foot pronation.	Measured during a single two hour session on day one of enrollment into the study.
Other	Hip internal and external rotation range (degrees)	Measured in sitting using a clinometer mobile application.	One two hour session on day one of enrollment into the study.
Other	Hip extension range (degrees)	Measured using the modified Thomas Test.	Measured during a single two hour session on day one of enrollment into the study.
Other	Knee to wall test (degrees)	Measured using a clinometer mobile application.	Measured during a single two hour session on day one of enrollment into the study.
Other	Isometric muscle strength of the hip abductors bilaterally (N/kg).	Measured bilaterally in the supine position via hand held dynamometer (J-Tech Limited).	Measured during single two hour session on day one of enrollment into the study.
Other	Isometric muscle strength of the hip extensors bilaterally (N/kg).	Measured bilaterally in the prone position via hand held dynamometer (J-Tech Limited).	Measured during single two hour session on day one of enrollment into the study.
Other	Isometric muscle strength of the knee extensors bilaterally (N/kg).	Measured bilaterally in a seated position via hand held dynamometer using a fixation belt(J-Tech Limited).	Measured during single two hour session on day one of enrollment into the study.
Other	Isometric muscle strength of the knee flexors bilaterally (N/kg).	Measured bilaterally in a seated position via hand held dynamometer using a fixation belt (J-Tech Limited).	Measured during single two hour session on day one of enrollment into the study.
Other	Isometric muscle strength of the plantar flexors bilaterally (N/kg).	Measured in a prone position via hand held dynamometer using a fixation belt (J-Tech Limited).	Measured during single two hour session on day one of enrollment into the study.
Primary	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.
Primary	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.
Primary	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	Peak range of motion (degrees) at the knee, hip and ankle during running.	Captured and extracted via Vicon Motion Analysis Software (Oxford, UK).	During a 15 minute run during one two hour session on day 1 of enrollment into the study.
Secondary	Injury history in the past 2 years.	Frequency, type and severity measured via online survey.	10 minute questionnaire on day one of enrollment into the study.
Secondary	Training history- type	Typical type of training (Distance, interval, hill, speed), measured via online survey.	10 minute questionnaire on day one of enrollment into the study.
Secondary	Training history-frequency	Typical frequency (sessions per week) measured via online survey.	10 minute questionnaire on day one of enrollment into the study.
Secondary	Training history- mileage	Typical mileage (km/week) and duration (minutes/session) measured via online survey.	10 minute questionnaire on day one of enrollment into the study.
Secondary	Training history- duration	Typical session duration (minutes/session) measured via online survey.	10 minute questionnaire on day one of enrollment into the study.