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

Condition(s) studied

Investigational drug(s) / intervention(s)

Return to play program with progressive design: 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.

Return to play program with regressive design: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
  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
• Sleep quality — 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.
  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.
• Stress (cortisol) — 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) 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
• Heart Rate Variability — 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.
  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.

Trial sites (1)

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