- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06919107
Advanced Footwear Technology in Federated Athletes
Use of Advanced Footwear Technology in Federated Athletes. An Ambispective Observational Study
Background. Athletics is one of the sports modalities with the greatest growth in the number of federative licenses in our country. In the last five years, the use of footwear with Advanced Footwear Technology (AFT) has become widespread in order to increase athletic performance.
Objective. To analyze the risk of injury in athletes using Advanced Footwear Technology as well as the sporting, sociodemographic and anthropometric variables that influence this risk.
Method. Ambispective cohort study. Ninety-five athletes competing in events longer than 800 meters will be recruited. The primary variable will be the number of injuries, muscular and tendon, of lower limbs in the last 3 athletic seasons. Secondary and modifying variables will be: age, sex, weekly training load with and without AFT, weekly training frequency, completion of a complementary toning program and foot size. Potential confounding variables will be body mass index, main training surface and commercial footwear models used. The analysis will calculate the risk of injury in these athletes and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders.
Expected results. To calculate the risk of injury as a function of sport, sociodemographic and anthropometric variables. Identify
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:
- Athletes competing in events longer than 800 meters; iii) athletes who have not undergone previous musculoskeletal surgery in the seasons under study.
- Federated in the Federación de Atletismo del Principado de Asturias (Asturias Athletics Federation).
- Athletes who have not undergone previous musculoskeletal surgery in the seasons under study.
- Who were federated at least one year before the study period.
Exclusion Criteria:
- Athletes who do not use AFT devices.
- Athletes with a muscle or tendon injury at the time of the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Athletes using advanced footwear technology
Athletes competing in events longer than 800 meters, federated in the Athletics Federation of the Principality of Asturias and using shoes with Advanced Footwear Technology.
Data will be collected on the number of injuries (muscle and tendon), lower limb injuries in the last 3 athletic seasons, as well as age, sex, weekly training load with and without AFT, weekly training frequency, completion of a complementary toning program and foot size
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Data will be collected on the number of injuries (muscle and tendon), lower limb injuries in the last 3 athletic seasons, as well as age, sex, weekly training load with and without AFT, weekly training frequency, completion of a complementary toning program and foot size.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the number of muscle and tendon injuries recorded by athletes in the lower limbs
Time Frame: Screening visit
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Number of lower limb muscle and tendon injuries during the last 3 athletic seasons
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Screening visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of age
Time Frame: Screening visit
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Measurement of age (measured in years completed, by requesting the date of birth to calculate this value).
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Screening visit
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Assessment of gender
Time Frame: Screening visit
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Measurement of gender (measured with a dichotomous variable: female / male)
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Screening visit
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Assessment of the weekly training load, using AFT or not
Time Frame: Screening visit
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Measurement of weekly training load with and without AFT (measured in kilometers traveled)
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Screening visit
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Assessment of weekly training frequency
Time Frame: Screening visit
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Measurement of weekly training frequency (measured in hours).
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Screening visit
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Assessment of the implementation of a complementary strengthening program
Time Frame: Screening visit
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Measurement of the implementation of a complementary strengthening program (measured with a dichotomous variable: yes/no).
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Screening visit
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Assessment of the size of athletes' feet
Time Frame: Screening visit
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Measurement of foot size (measured in international units)
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Screening visit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of body mass index
Time Frame: Screening visit
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Measurement of body mass index (measured as kg/m2).
This variable will be considered as a possible confounding variable
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Screening visit
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Assessment of the main training surface
Time Frame: Screening visit
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Measurement of the main training surface (response options: asphalt, dirt, track and tartan).
This variable will be considered as a possible confounding variable
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Screening visit
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Assessment of commercial footwear models used by athletes
Time Frame: Screening visit
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Measurement of commercial footwear models used (response options: Nike ZoomX Vaporfly NEXT%, Nike ZoomX Alphafly NEXT%, Adidas Adizero Adios Pro, Asics Metaspeed Sky, New Balance Fuelcell SuperComp Elite, Saucony Endorphin Pro, Puma Deviate Nitro Elite, and HOKA Rocket X).
This variable will be considered as a possible confounding variable
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Screening visit
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Assessment of athletes' weight
Time Frame: Screening visit
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Assessment of athletes' weight, measured in kg.
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Screening visit
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Assessment of the height of the athletes
Time Frame: Screening visit
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Assessment of the height of the athletes, measured in cm.
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Screening visit
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rubén Cuesta-Barriuso, PhD, 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
- Pathologic Processes
- Infections
- Skin Manifestations
- Skin Diseases
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Foot Diseases
- Mycoses
- Dermatomycoses
- Tinea
- Foot Dermatoses
- Pruritus
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Disease
- Tinea Pedis
Other Study ID Numbers
- ATL-foot
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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