Muscle Injury RTP Design in Football; Effects of Backward Design vs Forward Design.

NCT07012408 | Not Yet Recruiting DMC

• 1 other identifier: UniversitatBalears
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction "Return-to-play" (RTP) is an English term that corresponds to "return to competition". It is important to understand that this return is a constant, dynamic, and personalized decision-making process . The main objective of RTP is not to predict the exact moment of an athlete's return; rather, it is to prevent new injuries. For this, adequate decision-making is necessary. There are several important steps in the process, including correct diagnosis, strict control of workloads, and intelligent management of modifiers intrinsic to the sport that can lead to anxiety and stress How are the pieces of the RTP puzzle arranged and managed? How are RTP processes evaluated today? How should RTP be understood? Should it be understood statically, as a checklist, or as a constant decision-making process involving the player? Main objective: Evaluate the design of the RTP process for muscle injuries in sports. Specific objectives:

• To compare two RTP designs and evaluate how their design influences the anxiety experienced by the player.
• Identify variables that may be altered when choosing a regressive or progressive RTP design, such as sleep quality and cortisol level.
• To establish direction in the design of the RTP process.
• Create complete clinical guidelines on muscle injuries in sports with a focus on RTP design. Material and Methods Definition of the Study Subjects The subjects of the study will be all players belonging to the first or B team who suffer a muscle injury diagnosed by magnetic resonance imaging. At the time of injury, they will be randomly assigned to either the control group (following a regressive RTP design) or the intervention group (following a progressive RTP design). Masking will be double-blind. The sample size will be N=74. The secondary variables will be recorded in the database after diagnosis by MRI. Subsequently, the primary variables will be measured and recorded at the beginning, middle, and end of the RTP period. It is estimated that approximately half of the necessary sample size has been reached: about 37 subjects with muscle injury. The first statistical analysis will then be carried out to observe the preliminary results. After three years, once the analysis has been completed, the results and conclusions will be written up for publication in a journal.

Conditions

Muscle Injuries; Football Players

Keywords

Return to play; Design; effects

Outcome Measures

Primary Outcomes (4)

• Anxiety

  Player Anxiety During the Return-to-Play Process. GAD-7 Anxiety scale. This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively,of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

  It will be measured at the beginning, middle, and end of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• Sleep quality

  The quality of the player's sleep during the Return to Play process. This is measured with the Oura Ring, which uses a validated scale to quantify sleep quality. Oura's Sleep Score. 85-100: Optimal sleep quality. 70-84: Good sleep quality. 60-69: Fair sleep quality. 0-59: Areas for improvement are needed.

  It will be measured at the beginning, middle, and end of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• Stress (cortisol)

  Stress (cortisol) during the return-to-play process. We will measure it with the ELISA salivary kit to see how this hormone, which is directly related to the stress experienced by the athlete, varies. Cortisol levels are typically measured in micrograms per deciliter (mcg/dL) and fluctuate throughout the day, with the highest levels in the morning and the lowest at night. Normal ranges vary depending on the time of day and the testing method (blood, urine, or saliva), but generally, a healthy individual will have cortisol levels between 10-20 mcg/dL in the early morning (6-8 am) and 3-10 mcg/dL around 4 pm

  It will be measured at the beginning, middle, and end of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• Heart Rate Variability

  Player Heart Rate Variability During the Return-to-Play Process. Ouraring device. Interpreting HRV Scores: High HRV (e.g., 70 or higher): Associated with good health, a balanced autonomic nervous system, and better adaptability. Moderate HRV (e.g., 50-70): May indicate a need for improvement in areas like sleep, stress management, or nutrition. Low HRV (e.g., below 50): May indicate increased risk of health problems and a need for addressing underlying issues.

  It will be measured at the beginning, middle, and end of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

Secondary Outcomes (6)

• Age

  It will be measured and registered in the data base at the beginning of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• History of previous muscle injuries in the same muscle.

  It will be determined and registered in the data base at the beginning of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• Type of tissue involved in the muscle injury.

  It will be determined and registered in the data base at the beginning of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• The estimated medical prognosis of the player's discharge.

  It will be determined and registered in the data base at the beginning of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

• Weight

  It will be measured and registered in the data base at the beginning of the return-to-play process. This will be done for all subjects (muscle injuries) included in the study during the three years of the trial.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

The intervention group: Subjects with muscle injuries who are assigned to this group will follow a return-to-play program with a progressive design.

Other: Return to play program with progressive design

Control Group

EXPERIMENTAL

Control Group: The subjects (muscle injuries) that are assigned to this group will follow a Return to Play program with regressive design.

Other: Return to play program with regressive design

Interventions

Return to play program with progressive design OTHER

This design has more open objectives than the regressive design. In the progressive design, the duration of the return-to-play program is not determined by a future date, but rather by the player's daily progress. This design is less commonly used for scheduling tasks and planning work. It is intended to be compared with the regressive design to determine which is more appropriate.

Also known as: IG

Intervention Group

Return to play program with regressive design OTHER

Control Group: Subjects with muscle injuries assigned to this group will follow a Return to Play program with a regressive design. This design has fixed times and objectives from the beginning of the program to predict the athlete's exact discharge time. This design is commonly used for scheduling tasks and planning work. It is intended to evaluate the benefits and drawbacks of the design and compare them with those of the progressive design to determine which is more appropriate.

Also known as: CG

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: The study will only include injuries to male soccer players.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male soccer players.
• Diagnosed with a muscle injury via magnetic resonance imaging (MRI) during the three year study period.
• They will all belong to the same club.
• Age will be between 18 and 40 years old.

You may not qualify if:

• Patients (Muscle injuries) that do not cause players to miss training or competitions.
• Patients voluntarily decide not to participate in the study or abandon the RTP process due to transfers or other exceptional causes.

Sponsors & Collaborators

• Universitat de les Illes Balears: lead

Study Sites (1)

University of Balearic Islands

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

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  RESULT

Related Links

• Muscle injury guide Return to play management from Football Club Barcelona
• Return to play following injuries in pro football: insights into the real-life practices,progression strategies and reintegration processes
• How to Deal with Anxiety Around Return to Play
• Mentally Preparing Athletes to Return to Play Following Injury
• Cortisol and Stress recovery in handball team

Study Officials

• Olga Velasco, Phd Physio

  University of Balearic Islands

  STUDY DIRECTOR

Central Study Contacts

Oscar Vicente, PhD Stud.

CONTACT

+34 699 874 059; oscarvicente90@gmail.com

Carles Pedret, PhD MD

CONTACT

+34 609 624 203; info@carlespedret.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, double-blind, single-center controlled clinical trial. There will be two groups: a control group and an intervention group. The study will be carried out in the work environment of the principal investigator and doctoral student at the University of the Balearic Islands (UIB) and Club Atlético de Madrid. The study will focus on the first and B teams, which are based at the Ciudad Deportiva del Cerro del Espino in Majadahonda, Madrid. The study will be included in the principal investigator's doctoral thesis.

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD will be shared at the midpoint of the trial as part of the preliminary statistical analysis and at the end of the trial for the final statistical analysis and writing of the results and conclusions. The IPD will be coded using the patient code; therefore, there is no possibility of data exposure.
• Access Criteria: The principal investigator, the student in the Ph.D. program, the two thesis supervisors from the University of the Balearic Islands, and the group of statisticians from the same university who are in charge of the statistical analysis will have access to the IPD.

Locations

ES (1)