[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514007":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Zuyderland Medisch Centrum","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Blood flow restriction training (BFRT)","EXPERIMENTAL","Patients in the BFRT group will perform four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press, seated leg extension, deadlift and squat exercises with 30s inter-set rest periods throughout a 0-90° range of motion at 30% one-repetition maximum",[13],"Behavioral: Blood flow restriction training",{"label":15,"type":16,"description":17,"interventionNames":18},"Resistance training (RT)","ACTIVE_COMPARATOR","Patients in the resistance training group will perform 3x10 reps (30s inter-set rest) of unilateral leg press, seated leg extension, deadlift and squat exercises exercise throughout a 0-90° range of motion with incremental increase in external-load up to 70% of patients' one-repetition maximum",[19],"Behavioral: Resistance training",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Blood flow restriction training","BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Resistance training","Resistance training will be performed without any blood flow restriction",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Jasper Most","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Baris Koc, MD, PhDc","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Jasper Most, PhD","CONTACT","0031625159747","j.most@zuyderland.nl",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Zuyderland Medical Center","RECRUITING","Sittard","Limburg","6162 BG","Netherlands","NL",{"type":54,"coordinates":55},"Point",[56,57],5.86944,50.99833,{"lat":57,"lon":56},[60],{"name":33,"role":41,"phone":61,"phoneExt":26,"email":43},"+31(0)625159747",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100514007","graft-maturity-after-blood-flow-restriction-training-in-acl-reconstruction-100514007",false,"NCT05972876","Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction","MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study","TimeToMature","Inclusion Criteria:\n\n* Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.\n\nExclusion Criteria:\n\n* venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing\u002Fable to participate.","ALL","18 Years","65 Years",{"count":76,"type":77},46,"ESTIMATED","INTERVENTIONAL",[80],"NA","Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment.\n\nObjectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed.\n\nStudy design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing\u002Fable to participate.\n\nIntervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.\n\nComparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.\n\nMain study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.",[83,84],"Anterior Cruciate Ligament Reconstruction","Bone-Patellar Tendon-Bone Grafting",[86],"Blood Flow Restriction Therapy","2025-01-30",{"date":89,"type":90},"2025-02-04","ACTUAL",{"date":92,"type":90},"2024-04-17",{"date":94,"type":77},"2027-09",{"name":5,"class":6},1]