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

NCT07012408 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-06-18

No results posted yet for this 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.

Conditions

  • Muscle Injuries
  • Football Players

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Universitat de les Illes Balears

    lead OTHER

Principal Investigators

  • Olga Velasco, Phd Physio · University of Balearic Islands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-03-03
Completion
2028-09-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07012408 on ClinicalTrials.gov