[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593897":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":70,"collaborators":43,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":43,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":98,"whyStopped":43,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Universitat de les Illes Balears","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Return to play program with progressive design",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Return to play program with regressive design",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],[26],"IG",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[15],[32],"CG",[34],{"name":35,"affiliation":36,"role":37},"Olga Velasco, Phd Physio","University of Balearic Islands","STUDY_DIRECTOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Oscar Vicente, PhD Stud.","CONTACT","+34 699 874 059",null,"oscarvicente90@gmail.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Carles Pedret, PhD MD","+34 609 624 203","info@carlespedret.com",[50],{"facility":36,"status":43,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Palma de Mallorca","Balearic Islands","07010","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],2.65024,39.56939,{"lat":60,"lon":59},[63,67,68],{"name":64,"role":41,"phone":65,"phoneExt":43,"email":66},"Olga Velasco, PhD Physio","+34 617 649 807","olga.velasco@uib.es",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},{"name":40,"role":69,"phone":43,"phoneExt":43,"email":43},"PRINCIPAL_INVESTIGATOR",{"type":69,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Oscar Vicente Rodriguez","Principal Investigator","100593897","muscle-injury-rtp-design-in-football-effects-of-backward-design-vs-forward-design-100593897",false,"NCT07012408","Muscle Injury RTP Design in Football; Effects of Backward Design vs Forward Design.","Muscle Injury Return To Play Design in Football; Effects of Backward Design Versus Forward Design . A Randomized Controlled Trial","MIRTPD","Inclusion Criteria:\n\n* Male soccer players.\n* Diagnosed with a muscle injury via magnetic resonance imaging (MRI) during the three year study period.\n* They will all belong to the same club.\n* Age will be between 18 and 40 years old.\n\nExclusion Criteria:\n\n* Patients (Muscle injuries) that do not cause players to miss training or competitions.\n* Patients voluntarily decide not to participate in the study or abandon the RTP process due to transfers or other exceptional causes.","MALE","18 Years","40 Years",{"count":85,"type":86},74,"ESTIMATED","INTERVENTIONAL",[89],"NA","Introduction\n\n\"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\n\nHow are the pieces of the RTP puzzle arranged and managed?\n\nHow are RTP processes evaluated today?\n\nHow should RTP be understood? Should it be understood statically, as a checklist, or as a constant decision-making process involving the player?\n\nMain objective: Evaluate the design of the RTP process for muscle injuries in sports.\n\nSpecific objectives:\n\n* To compare two RTP designs and evaluate how their design influences the anxiety experienced by the player.\n* Identify variables that may be altered when choosing a regressive or progressive RTP design, such as sleep quality and cortisol level.\n* To establish direction in the design of the RTP process.\n* Create complete clinical guidelines on muscle injuries in sports with a focus on RTP design.\n\nMaterial and Methods\n\nDefinition of the Study Subjects\n\nThe 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.\n\nThe 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.\n\nIt 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.\n\nAfter three years, once the analysis has been completed, the results and conclusions will be written up for publication in a journal.",[92,93],"Muscle Injuries","Football Players",[95,96,97],"Return to play","Design","effects","NOT_YET_RECRUITING","2025-06-14",{"date":101,"type":102},"2025-06-18","ACTUAL",{"date":104,"type":86},"2025-09-01",{"date":106,"type":86},"2028-09-01",{"name":5,"class":6},1]