Musculoskeletal InjuryDCU RISCNCT03671395
The DCU Running Injury Surveillance Centre Study: A Prospective Investigation of Factors Relating to Running Injuries
An observational study of Musculoskeletal Injury, run by Dublin City University at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Injury
- How many people
- 315 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2018to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Novice and recreation runners.
Who may be able to join
- Runners aged 18-65
- Run minimum once per week
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The DCU Running Injury Surveillance Centre (RISC) Study: A Prospective Investigation of Factors Relating to Running Injuries
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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Musculoskeletal Injury
- Keywords
- Running Injuries, Motion Analysis, Biomechanics, Inertial Measurement Unit, Sensor Technology, Kinetic, Kinematic, Injury
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Captured and extracted via Vicon Motion Analysis Software (Oxford, UK).
Measured: 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.
Frequency, type and severity measured via online survey.
Measured: 10 minute questionnaire on day one of enrollment into the study.
Training history- type
Typical type of training (Distance, interval, hill, speed), measured via online survey.
Measured: 10 minute questionnaire on day one of enrollment into the study.
Training history-frequency
Typical frequency (sessions per week) measured via online survey.
Measured: 10 minute questionnaire on day one of enrollment into the study.
Training history- mileage
Typical mileage (km/week) and duration (minutes/session) measured via online survey.
Measured: 10 minute questionnaire on day one of enrollment into the study.
Training history- duration
Typical session duration (minutes/session) measured via online survey.
Measured: 10 minute questionnaire on day one of enrollment into the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Feb 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dublin City University
- Sponsor type
- University, hospital or other
- Collaborators
- Insight Centre for Data Analytics
- Responsible party
- Sponsor
- Investigators
- Aoife Burke, Principal investigator, Dublin City University, Insight Centre for Data AnalyticsSarah Dillon, Principal investigator, Dublin City University, Insight Centre for Data AnalyticsDr Kieran Moran, Principal investigator, Dublin City University, Insight Centre for Data Analytics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671395
- Sponsor's protocol ID
- SFI12/RC/2289
- Acronym
- DCU RISC
- Status last verified
- Jul 2020
- First submitted
- 2 May 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data may be shared to allow future analysis by other researchers.
Publications
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.
PubMed 22921763Buist 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.
PubMed 19966104Ghani 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.
PubMed 19228665Hespanhol 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.
PubMed 24287220Lun 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.
PubMed 15388542Malisoux 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.
PubMed 25174773Nielsen 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.
PubMed 26535228
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DCU Running Injury Surveillance Centre (RISC) Study: A Prospective Investigation of Factors Relating to Running Injuries
- ClinicalTrials.gov ID
- NCT03671395
- Acronym / sponsor ID
- DCU RISC / SFI12/RC/2289
- Conditions
- Musculoskeletal Injury
- Keywords
- Running Injuries, Motion Analysis, Biomechanics, Inertial Measurement Unit, Sensor Technology, Kinetic, Kinematic, Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Dublin City UniversityUniversity, hospital or other
- Collaborators
- Insight Centre for Data Analytics
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Novice and recreation runners.
Key inclusion criteria (2 listed)
- Runners aged 18-65
- Run minimum once per week
Key exclusion criteria (4 listed)
- No lower limb injury within the last three months
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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).
6 secondary outcomes
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.
Injury history in the past 2 years.
Time frame: 10 minute questionnaire on day one of enrollment into the study.
Training history- type
Time frame: 10 minute questionnaire on day one of enrollment into the study.
Training history-frequency
Time frame: 10 minute questionnaire on day one of enrollment into the study.
Training history- mileage
Time frame: 10 minute questionnaire on day one of enrollment into the study.
Training history- duration
Time frame: 10 minute questionnaire on day one of enrollment into the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Background: PubMed 22921763Bredeweg 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.
- Background: PubMed 19966104Buist 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.
- Background: PubMed 19228665Ghani 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.
- Background: PubMed 24287220Hespanhol 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.
- Background: PubMed 15388542Lun 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.
- Background: PubMed 25174773Malisoux 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.
- Background: PubMed 26535228Nielsen 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.
- Individual participant dataSharing planned: Undecided. Anonymised data may be shared to allow future analysis by other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aoife Burke principal investigator
Dublin City University, Insight Centre for Data Analytics
Sarah Dillon principal investigator
Dublin City University, Insight Centre for Data Analytics
Dr Kieran Moran principal investigator
Dublin City University, Insight Centre for Data Analytics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury, run by Dublin City University at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671395, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.