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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:
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.
Capturing and Recruiting Participants
Since the players are from the same club and suffer muscle injuries, they will be included in the control and intervention groups for three years. The following section will explain that the sampling technique is consecutive and that participants can take part in the study several times, as long as they have a muscle injury diagnosed by resonance. Relapses of the same injury or injuries in the same or different muscle groups will also be included in the sample. The head of the club's medical service and collaborating researcher, Dr. José María Villalón Alonso, will recruit the participants. After the diagnostic test (MRI) is performed and the diagnosis and prognosis are established, the participants will be handed over to the recovery specialists, who will design the RTP. The specialists and the participants (players) will be blinded in the same way.
Allocation Procedure/Randomization
Subjects (muscle injuries) have the same probability (50%) of being allocated to the control or intervention group, regardless of previous allocations.
Justification of Sample Size
A type of consecutive sampling will be carried out based on the average probability that a soccer player will suffer a muscular injury. On average, each player will suffer 0.6 muscular injuries per season. In a team of 25 soccer players, this translates to an average of 15 muscular injuries per season. By contrasting this data with the club's database, we can verify the accuracy of this estimate. According to this statistical data, the population from which we will extract the sample will be the total number of muscle injuries suffered by the two teams of Club Atlético Madrid over three years:
0.6 (injuries) x 50 (players) x 3 years = 90 muscle injuries. Using the Grammo sample calculator with a relative error of 5% and a 95% confidence interval, we will calculate the necessary sample size for the sample to be representative, which will be N = 74.
Statistical Analysis Plan:
Phase 1: Use Levene's test to check if the variances of the control and intervention groups are equal.
Phase 2: Use a t-test to determine if there is a significant difference between the means of the control and intervention groups, and to establish whether the null hypothesis (H0) or the alternative hypothesis (HA) is true.
Phase 3: Perform a bivariate study of the relationship between anxiety (dependent variable) and estimated prognosis (independent variable) using Pearson's correlation coefficient.
Phase 4: Conduct a multivariate study through multiple regression between the dependent variable, sleep quality, and the independent variables, age, type of affected tissue, and cortisol level.
Phase 5: Perform a multivariate study through simple linear regression between the dependent variable, anxiety, and the independent variable, previous injuries in the same musculature.
Ethical and Legal Aspects:
Compliance with the standards of Good Clinical Practice, the Declaration of Helsinki, the Oviedo Convention, and the Personal Data Protection and Guarantee of Digital Rights Act (LO 3/2018, December 5, 2018), as well as the regulations for managing clinical histories.
The investigator undertakes to comply with the aforementioned rules throughout the development of the research protocol, as well as in the presentation to this ethics committee, for which the investigator must provide a certificate of Good Clinical Practice (GCP). The collaborating investigators also have this GCP certificate.
Informed Consent Form:
The patient information sheet and informed consent form are both attached in Annexes 1 and 2.
The confidentiality of information collected in the context of the study is guaranteed.
Data Controller: Óscar Vicente Rodríguez TLF: 699 874 059 Email: oscarvicente90@gmail.com
Purpose of data collection: Clinical and epidemiological research.
Maximum period of data retention: The data will be kept for four years (three years for the duration of the study and one extra year for future research).
Processing, communicating, and transferring the personal data of all participating subjects will comply with the provisions of Organic Law 3/2018 of December 5 on the protection of personal data and the guarantee of digital rights.
In accordance with the aforementioned legislation, you may exercise your rights of access, rectification, deletion, opposition, and limitation of data processing. You may also transfer your data to an authorized third party (portability). For these requests, please contact the principal investigator responsible for processing at oscarvicente90@gmail.com or C/Moreno Torroba 10, 1o B, CP. 28220 Majadahonda, Madrid.
The data will be computerized and incorporated into an automated personal data system that complies with all security measures for restricted access, as described in this document.
To guarantee the confidentiality of the obtained information:
Your data and the sample will be identified by a code, and only the study physician and their collaborators will be able to relate this data to you and your medical history. Therefore, your identity will not be disclosed to anyone except in case of medical emergency or legal or administrative requirement.
Only the essential data necessary for the study will be transmitted to third parties and other countries. In no case will the data contain information that can directly identify you, such as your name, initials, address, or social security number. If this transfer occurs, it will be for the aforementioned study purposes and will guarantee confidentiality with at least the level of protection guaranteed by the legislation in force in our country.
Access to your personal information will be restricted to the study physiotherapist, collaborators, health authorities, the Balearic Islands Research Ethics Committee, and authorized personnel when required to verify the study's data and procedures, always maintaining confidentiality in accordance with current legislation.
You may contact the Spanish Data Protection Agency with any claims related to the processing of your personal data.
The handling of biological samples will be in accordance with Law 14/2007 and Royal Decree 1716/2011.
Saliva samples to determine cortisol levels will be collected at the Ciudad Deportiva Atlético de Madrid clinic on three occasions: at the beginning of the RTP, after the magnetic resonance imaging diagnosis, halfway through the established prognosis, and the day before the RTP ends. The analysis will be performed at the same clinic, where, at the end of the cortisol measurement, the saliva will be discarded and only the recorded cortisol value will be kept.
Any risks associated with the procedure used to collect these samples are covered by the study insurance.
The sample will be coded and treated confidentially throughout this study. A code will be used to link the sample to you, and only the investigator and his staff will be able to decipher it to preserve your identity.
If additional data or samples are needed, your physical therapist will contact you to request your cooperation.
You will be informed of the reasons and asked again for your consent if necessary.
It will not receive any economic benefits from the donation of samples or the transfer of provided data, nor will it have any rights to possible commercial benefits from discoveries resulting from the research.
The samples will be analyzed in the Ciudad Deportiva Atlético de Madrid laboratory and stored for four years in case additional analyses related to the study's objectives are necessary. The person responsible for the samples will be the study promoter during this process.
At the end of the research period, your sample may be:
Samples are stored in the Ciudad Deportiva Atlético de Madrid biobank for use in other research projects, which may be unrelated to the initial study for which consent was given. The biobank may provide samples to authorized projects, including those abroad, with prior approval from the scientific and ethics committees. You may contact the biobank to obtain information on projects in which your samples were used.
Insurance Policy or Justification of Absence for Experimental Studies
Mr. Óscar Vicente Rodríguez is the principal investigator and has the following identification number: 35.572.548, and is a member with no. 1224, is registered in the Collective Policy of Professional Civil Responsibility, to which the Official College of Physiotherapists of the Balearic Islands adheres, with number 531000009 from A.M.A. (Agrupación Mutual Aseguradora - La Mutua de los Profesionales Sanitarios). Annex 3.
Commitment to publishing the results
The principal investigator is committed to publishing the results, regardless of their nature, since there is no conflict of interest. This trial will be part of the doctoral student's (principal investigator) thesis, which guarantees the publication of the results to improve the design of the RTP process.
Financial report and source of financing
The project has no private funding other than the 3,235.45 euros provided by PI Oscar Vicente Rodriguez for the cortisol ELISA measurement kits, Oura rings, and tablets used to record expenses. The MRI and radiological report expenses are free for the club due to the entity's nature, with no conflict of interest. The same applies to the team of statisticians who can analyze the results. They are part of the UIB and collaborate with doctoral theses. This essay is one such work. Regarding the CEIm of the Balearic Islands, this trial is exempt from fees (see the documentation), as it is part of the UIB's Doctoral School studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age of player who suffered the muscle injury | 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. |
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Inclusion Criteria:
Exclusion Criteria:
The study will only include injuries to male soccer players.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oscar Vicente, PhD Stud. | Contact | +34 699 874 059 | oscarvicente90@gmail.com | |
| Carles Pedret, PhD MD | Contact | +34 609 624 203 | info@carlespedret.com |
| Name | Affiliation | Role |
|---|---|---|
| Olga Velasco, Phd Physio | University of Balearic Islands | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Balearic Islands | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32024646 | Result | Orchard JW, Chaker Jomaa M, Orchard JJ, Rae K, Hoffman DT, Reddin T, Driscoll T. Fifteen-week window for recurrent muscle strains in football: a prospective cohort of 3600 muscle strains over 23 years in professional Australian rules football. Br J Sports Med. 2020 Sep;54(18):1103-1107. doi: 10.1136/bjsports-2019-100755. Epub 2020 Feb 5. | |
| 28966376 |
| Label | URL |
|---|---|
| Muscle injury guide Return to play management from Football Club Barcelona | View source |
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As part of a doctoral program's research plan, this essay's IPD will be shared with the thesis directors. The IPD is confidential and is only for this research.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 25, 2025 | May 31, 2025 | Prot_SAP_ICF_000.pdf |
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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.
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|
| 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. |
|
|
| 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. |
History (Yes or No) of previous muscle injuries in the same muscle that suffers the injury that is included in the study. |
| 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. | The type of tissue involved in the muscle injury is indicated by the radiological report and the BAMIC scale. | 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. | 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'. | 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 | Player weight in the moment of start Return to play | 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. |
| Height | Height of player | 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. |
| Dhillon H, Dhillon S, Dhillon MS. Current Concepts in Sports Injury Rehabilitation. Indian J Orthop. 2017 Sep-Oct;51(5):529-536. doi: 10.4103/ortho.IJOrtho_226_17. |
| 31469710 | Result | Dattilo M, Antunes HKM, Galbes NMN, Monico-Neto M, DE Sa Souza H, Dos Santos Quaresma MVL, Lee KS, Ugrinowitsch C, Tufik S, DE Mello MT. Effects of Sleep Deprivation on Acute Skeletal Muscle Recovery after Exercise. Med Sci Sports Exerc. 2020 Feb;52(2):507-514. doi: 10.1249/MSS.0000000000002137. |
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| Return to play following injuries in pro football: insights into the real-life practices,progression strategies and reintegration processes | View source |
| A Return-to-Performance Pathway for Professional Soccer | View source |
| How to Deal with Anxiety Around Return to Play | View source |
| Mentally Preparing Athletes to Return to Play Following Injury | View source |
| Cortisol and Stress recovery in handball team | View source |