Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-25 @ 7:31 PM
Study NCT ID:
NCT03671395
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DCU Running Injury Surveillance Centre Study: A Prospective Investigation of Factors Relating to Running Injuries
Sponsor:
Dublin City University
Organization:
Study Overview
Official Title:
The DCU Running Injury Surveillance Centre (RISC) Study: A Prospective Investigation of Factors Relating to Running Injuries
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCU RISC
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: