[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576671":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":65,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Valencia","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard exercises with BFRT","EXPERIMENTAL","Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation.",[13,14],"Other: Standard rehabilitation","Device: Blood Flow Restriction Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard exercises alone","ACTIVE_COMPARATOR","Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises without BFRT during the three phases of standard rehabilitation.",[13],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Standard rehabilitation","Protocol based on the best available evidence and to be used in all participants in both groups. The standard exercises protocol will consist of three postoperative rehabilitation phases: phase I (weeks 1 to 4), phase II (weeks 5 to 8) and phase III (weeks 9 to 12). Sessions will be held 2 times a week for 12 weeks. Each session will last 45 minutes and will consist of six exercises in the phase I, eight exercises in phase II, and eight exercises in phase III.",[16,9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Blood Flow Restriction Therapy","Participants will perform three exercises of the standard exercises protocol with BFRT. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. Each BFRT session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 50% of the maximum occlusion pressure in the first stage and 60% in stages II and III. The participant will perform 75 repetitions per BFRT exercise divided into 4 sets (30, 15, 15, and 15 repetitions). The load intensity during the BFRT exercises will be set near to 3 out of 10 on the Borg's CR10 scale (\"weak\"), which corresponds to 30% of a 1RM effort. After each exercise, the cuff will be deflated, and the patient will rest for two minutes.",[9],[32],{"name":33,"affiliation":34,"role":35},"Felipe Ponce-Fuentes, MSc","Universidad Mayor","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"José Casaña, PhD","CONTACT","+34656437371","jose.casana@uv.es",{"name":33,"role":39,"phone":43,"phoneExt":25,"email":44},"+56954411974","felipe.poncef@umayor.cl",[46],{"facility":47,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Clínica RedSalud Mayor","Temuco","Cautín","4800580","Chile","CL",{"type":54,"coordinates":55},"Point",[56,57],-72.59738,-38.73628,{"lat":57,"lon":56},[60,64],{"name":61,"role":39,"phone":62,"phoneExt":25,"email":63},"Daniela Mansilla","+56996521664","daniela.mansilla@redsalud.cl",{"name":33,"role":39,"phone":25,"phoneExt":25,"email":25},{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"José Casaña Granell","PhD","100576671","blood-flow-restriction-versus-standard-exercise-after-rotator-cuff-repair-100576671",false,"NCT06788327","Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair","Comparing the Effectiveness of Blood Flow Restriction Therapy Versus Standard Exercise After Arthroscopic Rotator Cuff Repair: Protocol for the Multicenter S-TRONGER Randomized Controlled Trial","S-TRONGER","Inclusion Criteria:\n\n* Age between 40-65 years\n* Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging\n* Undergoing arthroscopic rotator cuff repair\n* Be able to read and understand Spanish\n\nExclusion Criteria:\n\n* Massive irreparable rotator cuff tear\n* Concomitant fracture\n* Labral or nerve injury\n* Suspicious of developing a frozen shoulder\n* Revision surgery after rotator cuff repair\n* Previous corticosteroid injection (\\\u003C 6 months)\n* Recent surgery (\\\u003C 1 year) in the contralateral shoulder\n* History of deep venous thrombosis\u002Fpulmonary embolism, peripheral vascular disease, thrombophilia or clotting disorders\n* Severe or uncontrolled hypertension, or any comorbid condition that impedes participants to complete the intervention","ALL","40 Years","65 Years",{"count":80,"type":81},50,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.\n\nPatients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.",[87,88,89],"Rotator Cuff Injury","Rotator Cuff Tears","Rotator Cuff Repair",[91,92],"blood flow restriction therapy","blood flow restriction training","NOT_YET_RECRUITING","2025-01-16",{"date":96,"type":97},"2025-01-23","ACTUAL",{"date":99,"type":81},"2025-03-03",{"date":101,"type":81},"2027-08-31",{"name":5,"class":6},1]