## Protocol Section
### Identification Module
**NCT ID:** NCT06425809

**Brief Title:** Predictors of Muscle Injury Risk in Non-professional Football Players

**Official Title:** Predictors of Muscle Injury Risk in Non-professional Football Players From the Principality of Asturias. An Ambispective Cohort Study.

#### Organization Study ID Info
**ID:** Pred-Fut
#### Organization
**Class:** OTHER
**Full Name:** University of Oviedo
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Oviedo

#### Responsible Party

**Investigator Affiliation:** University of Oviedo

**Investigator Full Name:** Ruben Cuesta Barriuso

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Sport Injury

**Keywords:**

- Muscular Diseases

- Football

- Risk

- Secondary Prevention

- Physiotherapy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 97

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Observation

**Label:** Observational group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Observational group

**Description:** 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).

**Name:** Observation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Asses the number of lower limb muscle injuries in the last 3 competition seasons

**Time Frame:** Screening visit

#### Secondary Outcomes

**Description:** The secondary variable, age (in years completed), will be assessed as a quantitative variable.

**Measure:** Assess the age

**Time Frame:** Screening visit

**Description:** The secondary variable, body mass index (in kg/m2), will be assessed as a quantitative variable.

**Measure:** Assess the body mass index

**Time Frame:** Screening visit

**Description:** The secondary variable, type of training and competition boot (rubber cleat/metal cleat), will be assessed as a nominal qualitative variable.

**Measure:** Assess the type of training and competition boot in the last 3 competition seasons

**Time Frame:** Screening visit

**Description:** 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.

**Measure:** Assess the type of training and competition pitch in the last 3 competition seasons

**Time Frame:** Screening visit

**Description:** The secondary variable, type of muscle injury (fibrillar / musculotendinous / strain), will be assessed as an ordinal qualitative variable.

**Measure:** Assess the type of muscle injury in the last 3 competition seasons

**Time Frame:** Screening visit

**Description:** The secondary variable, weekly training load (hours/week), will be assessed as a quantitative variable.

**Measure:** Assess the weekly training load in the last 3 competition seasons

**Time Frame:** Screening visit

**Description:** The secondary variable, position on the field (goalkeeper / defender / midfielder / striker), will be assessed as an ordinal qualitative variable.

**Measure:** Assess the position on the field in the last 3 competition seasons

**Time Frame:** Screening visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cuestaruben@uniovi.es

**Name:** Rubén Cuesta-Barriuso, PhD

**Phone:** 607547274

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Oviedo

**Country:** Spain

**Facility:** University of Oviedo

**State:** Asturias

**Zip:** 33006

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M4570

- Name: Athletic Injuries

- Relevance: HIGH

- As Found: Sport Injury

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000001265

- Term: Athletic Injuries

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M5953

- Name: Chlorhexidine

- Relevance: LOW

- As Found: Unknown

- ID: M344731

- Name: Chlorhexidine gluconate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
