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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671395
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Insight Centre for Data Analytics
Information provided by (Responsible Party):
Dublin City University

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.


Condition or disease
Musculoskeletal Injury

Detailed 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.

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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The DCU Running Injury Surveillance Centre (RISC) Study: A Prospective Investigation of Factors Relating to Running Injuries
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020



Primary Outcome Measures :
  1. The occurrence of a running-related injury [ Time Frame: 6 week intervals from enrollment in the study, up to the total study time period of 2 years. ]
    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.

  2. Peak loading (N/s) during running and jumping movements. [ Time Frame: One two hour session on day one of enrollment into the study. ]
    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).

  3. Rate of loading (N/s2) during running. [ Time Frame: One two hour session on day one of enrollment into the study ]
    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).


Secondary Outcome Measures :
  1. Peak range of motion (degrees) at the knee, hip and ankle during running. [ Time Frame: During a 15 minute run during one two hour session on day 1 of enrollment into the study. ]
    Captured and extracted via Vicon Motion Analysis Software (Oxford, UK).

  2. Injury history in the past 2 years. [ Time Frame: 10 minute questionnaire on day one of enrollment into the study. ]
    Frequency, type and severity measured via online survey.

  3. Training history- type [ Time Frame: 10 minute questionnaire on day one of enrollment into the study. ]
    Typical type of training (Distance, interval, hill, speed), measured via online survey.

  4. Training history-frequency [ Time Frame: 10 minute questionnaire on day one of enrollment into the study. ]
    Typical frequency (sessions per week) measured via online survey.

  5. Training history- mileage [ Time Frame: 10 minute questionnaire on day one of enrollment into the study. ]
    Typical mileage (km/week) and duration (minutes/session) measured via online survey.

  6. Training history- duration [ Time Frame: 10 minute questionnaire on day one of enrollment into the study. ]
    Typical session duration (minutes/session) measured via online survey.


Other Outcome Measures:
  1. Foot Posture Index (Scale, scoring from -12 to +12) [ Time Frame: Measured during a single two hour session on day one of enrollment into the study. ]
    Measure of static foot position.

  2. Navicular drop (mm) [ Time Frame: Measured during a single two hour session on day one of enrollment into the study. ]
    Measure of dynamic foot pronation.

  3. Hip internal and external rotation range (degrees) [ Time Frame: One two hour session on day one of enrollment into the study. ]
    Measured in sitting using a clinometer mobile application.

  4. Hip extension range (degrees) [ Time Frame: Measured during a single two hour session on day one of enrollment into the study. ]
    Measured using the modified Thomas Test.

  5. Knee to wall test (degrees) [ Time Frame: Measured during a single two hour session on day one of enrollment into the study. ]
    Measured using a clinometer mobile application.

  6. Isometric muscle strength of the hip abductors bilaterally (N/kg). [ Time Frame: Measured during single two hour session on day one of enrollment into the study. ]
    Measured bilaterally in the supine position via hand held dynamometer (J-Tech Limited).

  7. Isometric muscle strength of the hip extensors bilaterally (N/kg). [ Time Frame: Measured during single two hour session on day one of enrollment into the study. ]
    Measured bilaterally in the prone position via hand held dynamometer (J-Tech Limited).

  8. Isometric muscle strength of the knee extensors bilaterally (N/kg). [ Time Frame: Measured during single two hour session on day one of enrollment into the study. ]
    Measured bilaterally in a seated position via hand held dynamometer using a fixation belt(J-Tech Limited).

  9. Isometric muscle strength of the knee flexors bilaterally (N/kg). [ Time Frame: Measured during single two hour session on day one of enrollment into the study. ]
    Measured bilaterally in a seated position via hand held dynamometer using a fixation belt (J-Tech Limited).

  10. Isometric muscle strength of the plantar flexors bilaterally (N/kg). [ Time Frame: Measured during single two hour session on day one of enrollment into the study. ]
    Measured in a prone position via hand held dynamometer using a fixation belt (J-Tech Limited).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Novice and recreation runners.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671395


Locations
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Ireland
Dublin City University
Dublin, Leinster, Ireland, D09 Y5N0
Sponsors and Collaborators
Dublin City University
Insight Centre for Data Analytics
Investigators
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Principal Investigator: 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
Publications:

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Responsible Party: Dublin City University
ClinicalTrials.gov Identifier: NCT03671395    
Other Study ID Numbers: SFI12/RC/2289
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymised data may be shared to allow future analysis by other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dublin City University:
Running Injuries
Motion Analysis
Biomechanics
Inertial Measurement Unit
Sensor Technology
Kinetic
Kinematic
Injury
Additional relevant MeSH terms:
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Wounds and Injuries