- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04221698
Do Young Triathletes Have a Greater Predisposition to Suffer Running Injuries
In running 70% of the lower limb, injuries are produced in the running segment. The vast majority of sports-related musculoskeletal injuries in young athletes are caused by overuse. Previous research has shown a clear association between running-related injuries and kinematic patterns, showing the existence of a causal relationship between biomechanical alterations and injures.
According to the evidence, that real-time visual and auditory feedback based on gait retraining should be considered to treat injured runners or prevent injuries. However, no previous studies have been carried out on whether gait retraining decreases running-related injuries incidence in young triathletes.
The investigators propose a study to determine the effect of gait retraining on the decrease in the number of running-related injuries and improve the running efficiency in young triathletes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Alfara Del Patriarca, Valencia, Spain, 46113
- Juan J. Amer-Cuenca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Triathletes included in the Triathlon Plan in High Performance of the Valencian Community in Spain.
- Reported running a minimum of 2 days per week for the last 3 months with no reported injury.
- Worst pain rated a minimum of 3 out 10 on a numerical rating scale (NRS) for pain (0=no pain, 10=worst possible pain)
Exclusion Criteria:
- Previous musculoskeletal surgery.
- Neurological impairment
- Structural deformity in the knee.
- Pain suffered by trauma or sports activity, having stopped running or receiving additional treatment outside the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gait Retraining Group
Athletes from the Triathlon Plan in High Performance of the Valencian Community in Spain performing individual gait retraining sessions
|
5 gait retraining sessions of continuous feedback in real time during running sessions; using videotape feedback, a digital metronome to increase step rate, and verbal feedback to reduce the tendency to heel strike upon ground contact.
Verbal feedback is offered during the 25- to 30-minute running sessions following a series of drills aimed at improving running mechanics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surface Electromyography
Time Frame: Baseline - 7 months
|
Mean activation amplitude of gluteus medius.
|
Baseline - 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3D Kinematic Analysis
Time Frame: Baseline - 7 months
|
Peak angle at midstance defined as of the maximum pelvis joint angle between initial contact and toe-off.
The tool to assess this variable would be an Inertial measurement unit (IMU) located at sacral vertebra S1
|
Baseline - 7 months
|
|
Maximal Oxygen Consumption (VO2max)
Time Frame: Baseline - 7 months
|
Oxygen Consumption during running
|
Baseline - 7 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-report Questionnaire about Running-related injuries
Time Frame: Baseline - 7 months
|
By means of a self-report questionnaire according to previous research in triathletes to document the incidence of overuse injuries previous and post gait retraining protocol season.
Higher scores (number of injuries) mean a worse outcome.
|
Baseline - 7 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier Martínez-Gramage, PhD, CEU Cardenal Herrera University
Publications and helpful links
General Publications
- Bramah C, Preece SJ, Gill N, Herrington L. A 10% Increase in Step Rate Improves Running Kinematics and Clinical Outcomes in Runners With Patellofemoral Pain at 4 Weeks and 3 Months. Am J Sports Med. 2019 Dec;47(14):3406-3413. doi: 10.1177/0363546519879693. Epub 2019 Oct 28.
- Bramah C, Preece SJ, Gill N, Herrington L. Is There a Pathological Gait Associated With Common Soft Tissue Running Injuries? Am J Sports Med. 2018 Oct;46(12):3023-3031. doi: 10.1177/0363546518793657. Epub 2018 Sep 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEI18/137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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