- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906666
Analysis of Injury Risk Factors in Elite Athletes
Analysis of Injury Risk Factors in Elite Athletes. A Cross-sectional Cohort Study.
Background information. The different disciplines of athletics place high physical demands on athletes. These different categories of running vary in terms of physical effort and duration, generating different levels of risk of injury. The description of the main injuries that affect elite athletes in the different athletics disciplines, as well as the identification of the specific risk factors of each discipline, will allow the identification of preventive measures to be implemented.
Objective. To identify the risk factors for tendon injury in professional long- and middle-distance athletes, according to the type of event, and to identify the best predictive model for tendon injuries based on anthropometric and athletic variables.
Method. Ambispective cohort study. 81 elite athletes will be recruited. The primary variable will be the number of tendon injuries in the last three seasons. The secondary and modifying variables will be: age (in completed years), weekly training load (in minutes), type of footwear (sneakers without carbon plate, sneakers with carbon plate, spiked sneakers without carbon plate and spiked sneakers with carbon plate), diet (balanced, high in carbohydrates, high-protein, controlled hypocaloric and adapted to the training cycle) and the regular practice of another physical activity. The possible confounding variables will be the body mass index, the date of tendon injuries in that period and the time spent as a federated athlete (in completed months). The analysis will calculate the risk of injury in these athletes and assess the influence of confounding factors and trend analysis on the primary variable, stratified by possible confounding factors.
Expected results. To calculate the risk of injury in elite athletes based on anthropometric and sociodemographic variables. To identify the predictive model of tendon injuries in elite athletes
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Principality of Asturias
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Oviedo, Principality of Asturias, Spain, 33006
- University of Oviedo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Elite federated athletes
- Who have not undergone previous musculoskeletal surgery in the seasons under study
- Who were federated at least one year before the study period
- Sign the informed consent document.
Exclusion Criteria:
- Athletes who have not participated in competition, during the study seasons, for a period of more than 6 months due to a musculoskeletal injury
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Observacional group
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Elite athletes in whom the risk of injury will be calculated and the influence of confounding factors will be assessed through a personal interview.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of number of lower limb tendon injuries
Time Frame: Screening visit
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The primary variable will be the number of lower limb tendon injuries in the last three seasons
|
Screening visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of age
Time Frame: Screening visit
|
The measurement of age (measured in completed years) will be a secondary variable.
|
Screening visit
|
|
Measurement of the weekly training load
Time Frame: Screening visit
|
The measurement of the weekly training load (measured in minutes) will be a secondary variable.
|
Screening visit
|
|
Measurement of the type of footwear
Time Frame: Screening visit
|
The evaluation of the type of footwear (with the response options: shoe without carbon plate, shoe with carbon plate, spike shoe without carbon plate and spike shoe with carbon plate) will be a secondary variable.
|
Screening visit
|
|
Measurement of the type of diet
Time Frame: Screening visit
|
The evaluation of the type of diet (with the response options: balanced, rich in carbohydrates, rich in proteins and adapted to the training cycle) will be a secondary variable.
|
Screening visit
|
|
Measurement of the practice of another physical activity
Time Frame: Screening visit
|
The evaluation of the practice of another physical activity on a regular basis will be a secondary variable.
|
Screening visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the body mass index
Time Frame: Screening visit
|
The measurement of the body mass index (measured in kg/m2) will be a possible confounding variable.
|
Screening visit
|
|
Measurement of the date of tendon injuries
Time Frame: Screening visit
|
The date of tendon injuries in that period will be a possible confounding variable.
|
Screening visit
|
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Measurement of federated time
Time Frame: Screening visit
|
The evaluation of federated time (measured in completed months) will be a possible confounding variable.
|
Screening visit
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rubén Cuesta-Barriuso, Universidad de Oviedo
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATL-risk
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
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