Muscle Injury Return To Play Design in Football; Effects of Backward Design Versus Forward Design . A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anxiety
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Height(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.)
- 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.)
研究者
Oscar Vicente Rodriguez
Principal Investigator
Universitat de les Illes Balears