NCT06919107

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

May 1, 2026

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 25, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

DiseaseAthleticsAdvanced Footwear TechnologyRiskSecondary PreventionPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Assessment of the number of muscle and tendon injuries recorded by athletes in the lower limbs

    Number of lower limb muscle and tendon injuries during the last 3 athletic seasons

    Screening visit

Secondary Outcomes (6)

  • Assessment of age

    Screening visit

  • Assessment of gender

    Screening visit

  • Assessment of the weekly training load, using AFT or not

    Screening visit

  • Assessment of weekly training frequency

    Screening visit

  • Assessment of the implementation of a complementary strengthening program

    Screening visit

  • +1 more secondary outcomes

Other Outcomes (5)

  • Assessment of body mass index

    Screening visit

  • Assessment of the main training surface

    Screening visit

  • Assessment of commercial footwear models used by athletes

    Screening visit

  • +2 more other outcomes

Study Arms (1)

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

Other: Survey of athletes

Interventions

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.

Athletes using advanced footwear technology

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Federated athletes competing in events over 800 meters in the Principality of Asturias.

You may qualify if:

  • 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.

You may not qualify if:

  • Athletes who do not use AFT devices.
  • Athletes with a muscle or tendon injury at the time of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Tinea PedisDisease

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad de Oviedo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 9, 2025

Study Start

March 31, 2025

Primary Completion

April 30, 2025

Study Completion

May 15, 2025

Last Updated

May 1, 2026

Record last verified: 2025-03

Locations