Muscle Injury RTP Design in Football; Effects of Backward Design vs Forward Design.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-40
SponsorUniversitat de les Illes Balears
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Return to play program with progressive design
Other interventionThis 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
Other interventionControl 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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
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.2
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.
Time frame
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.3
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
Time frame
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.4
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.
Time frame
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
1
Age
Age of player who suffered the muscle injury
Time frame
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.2
History of previous muscle injuries in the same muscle.
History (Yes or No) of previous muscle injuries in the same muscle that suffers the injury that is included in the study.
Time frame
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.3
Type of tissue involved in the muscle injury.
The type of tissue involved in the muscle injury is indicated by the radiological report and the BAMIC scale.
Time frame
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.4
The estimated medical prognosis of the player's discharge.
The estimated medical prognosis of the player's discharge is reported in the radiology report and categorized using the BAMIC scale. The British Athletics Muscle Injury Classification proposes a new system, based on the available evidence, which should provide a sound diagnostic base for therapeutic decision-making and prognostication. Injuries are graded 0-4 based on MRI features, with Grades 1-4 including an additional suffix 'a', 'b' or 'c' if the injury is 'myofascial', 'musculo-tendinous' or 'intratendinous'.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov
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