Sport InjuryNCT06425809
Predictors of Muscle Injury Risk in Non-professional Football Players
An observational study of Sport Injury, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Sport Injury
- What is being tested?
- Observation
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2024to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Muscle Injury Risk in Non-professional Football Players From the Principality of Asturias. An Ambispective Cohort Study.
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.
Read more
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.
- Conditions
- Sport Injury
- Being tested
- Observation
- Keywords
- Muscular Diseases, Football, Risk, Secondary Prevention, Physiotherapy
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening visit
Secondary outcomes (7)
Assess the age
The secondary variable, age (in years completed), will be assessed as a quantitative variable.
Measured: Screening visit
Assess the body mass index
The secondary variable, body mass index (in kg/m2), will be assessed as a quantitative variable.
Measured: Screening visit
Assess the type of training and competition boot in the last 3 competition seasons
The secondary variable, type of training and competition boot (rubber cleat/metal cleat), will be assessed as a nominal qualitative variable.
Measured: Screening visit
Assess the type of training and competition pitch in the last 3 competition seasons
The secondary variable, type of training and competition pitch (sand pitch / artificial turf pitch / natural grass pitch), will be assessed as a nominal qualitative variable.
Measured: Screening visit
Assess the type of muscle injury in the last 3 competition seasons
The secondary variable, type of muscle injury (fibrillar / musculotendinous / strain), will be assessed as an ordinal qualitative variable.
Measured: Screening visit
Assess the weekly training load in the last 3 competition seasons
The secondary variable, weekly training load (hours/week), will be assessed as a quantitative variable.
Measured: Screening visit
Assess the position on the field in the last 3 competition seasons
The secondary variable, position on the field (goalkeeper / defender / midfielder / striker), will be assessed as an ordinal qualitative variable.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start20 May 2024
- Primary completion15 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Cuesta Barriuso, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425809
- Sponsor's protocol ID
- Pred-Fut
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Muscle Injury Risk in Non-professional Football Players From the Principality of Asturias. An Ambispective Cohort Study.
- ClinicalTrials.gov ID
- NCT06425809
- Acronym / sponsor ID
- Pred-Fut
- Conditions
- Sport Injury
- Keywords
- Muscular Diseases, Football, Risk, Secondary Prevention, Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: ObservationData 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThe 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). | Other | Observational group |
Primary outcome
Asses the number of lower limb muscle injuries in the last 3 competition seasons
Time frame: Screening visit
The primary variable, the number of lower limb muscle injuries in the last 3 seasons, will be assessed as a quantitative variable.
7 secondary outcomes
Assess the age
Time frame: Screening visit
Assess the body mass index
Time frame: Screening visit
Assess the type of training and competition boot in the last 3 competition seasons
Time frame: Screening visit
Assess the type of training and competition pitch in the last 3 competition seasons
Time frame: Screening visit
Assess the type of muscle injury in the last 3 competition seasons
Time frame: Screening visit
Assess the weekly training load in the last 3 competition seasons
Time frame: Screening visit
Assess the position on the field in the last 3 competition seasons
Time frame: Screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sport Injury, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asses the number of lower limb muscle injuries in the last 3 competition seasons (time frame: Screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.