NCT06425809

Brief Summary

Background. Football accounts for 30% of all sports injuries. Muscle injuries in football are the most common non-traumatic and non-contact injuries. A comprehensive approach to injury prevention must consider the design of the footwear and the environmental conditions in which the match is played. Objective. To assess the risk of injury as a function of footwear and field of play in non-professional football players and to identify the best predictive model of muscle injury in these athletes. Method. Ambispective cohort study. Ninety-seven players will be recruited. The primary variable will be the number of lower limb muscle injuries in the last 3 seasons. Secondary and modifying variables will be: age, body mass index, boot type, pitch turf, training load and field position. Potential confounding variables will be motivation for choice of footwear, date of muscle injuries, time playing in the category and presence in the starting team. The analysis will calculate the risk of adverse effects in these patients and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders. Expected outcomes. To calculate the risk of muscle injury as a function of anthropometric variables, and footwear and turf type. To identify the predictive model of muscle injuries in football players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

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

May 14, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 26, 2025

Status Verified

May 1, 2024

Enrollment Period

26 days

First QC Date

May 14, 2024

Last Update Submit

March 25, 2025

Conditions

Keywords

Muscular DiseasesFootballRiskSecondary PreventionPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Asses the number of lower limb muscle injuries in the last 3 competition seasons

    The primary variable, the number of lower limb muscle injuries in the last 3 seasons, will be assessed as a quantitative variable.

    Screening visit

Secondary Outcomes (7)

  • Assess the age

    Screening visit

  • Assess the body mass index

    Screening visit

  • Assess the type of training and competition boot in the last 3 competition seasons

    Screening visit

  • Assess the type of training and competition pitch in the last 3 competition seasons

    Screening visit

  • Assess the type of muscle injury in the last 3 competition seasons

    Screening visit

  • +2 more secondary outcomes

Study Arms (1)

Observational group

Data collection will take place between May and June 2024. This will be done through a self-questionnaire format with closed questions where no data will be collected that allow the identification of the subject (name, surname, or national identity document). The coding of the data collected and its analysis will be carried out under the supervision of the principal investigator, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the patients whose data are collected.

Other: Observation

Interventions

The data collection will be carried out by the two researchers, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the athletes whose data are collected. The members of the research group will not have access to personal data that could facilitate the identity of any person on the basis of the data collected. The data collected in this study, anonymised from the outset, will be exported to an Excel file. Access to the Excel file will require password access and will be managed from a computer of the University of Oviedo (Department of Surgery and Medical-Surgical Specialities).

Observational group

Eligibility Criteria

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

Population: Non-professional football players from the Principality of Asturias, where the aim is to identify the risk of muscle injuries in these players and to identify the predictive model of muscle injuries based on anthropometric and sporting variables.

You may qualify if:

  • Federated, non-professional football players.
  • Competing in category 3 RFEF (group 2).
  • Who compete in the territorial delimitation of the Principality of Asturias.
  • Subjects 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:

  • Players who have not participated in competition, during the seasons under study, for a period of more than 6 months due to a musculoskeletal injury.

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

Muscular Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 22, 2024

Study Start

May 20, 2024

Primary Completion

June 15, 2024

Study Completion

July 1, 2024

Last Updated

March 26, 2025

Record last verified: 2024-05

Locations