[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554203":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Denver Health and Hospital Authority","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Blood flow restriction training","EXPERIMENTAL","Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device",[13],"Device: Blood Flow Restriction with low load exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional physical therapy","ACTIVE_COMPARATOR","Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice.",[19],"Other: Therapeutic Exercise",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Blood Flow Restriction with low load exercise","Cuff\u002Ftourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Therapeutic Exercise","Exercise performed at appropriate load as guided by physical therapist",[15],[32],{"name":33,"affiliation":34,"role":35},"Megan E Smith, PT, DPT","Denver Health","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","6513191730","megan.smith@dhha.org",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Mathew A Haager, PT, DPT","5639407061","mat.haager@dhha.org",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Denver Health Medical Center","RECRUITING","Denver","Colorado","80204","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-104.9847,39.73915,{"lat":58,"lon":57},[61,63],{"name":33,"role":38,"phone":62,"phoneExt":26,"email":40},"651-319-1730",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100554203","blood-flow-restriction-training-in-patients-with-lower-extremity-fractures-100554203",false,"NCT06496035","Blood Flow Restriction Training in Patients With Lower Extremity Fractures","Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures: Effect on Fracture Healing, Muscle Strength and Girth, and Return to Function","Inclusion Criteria:\n\n* Adult with closed tibial shaft fracture\n* Ability to begin physical therapy treatment within 2 weeks post-operatively\n\nExclusion Criteria:\n\n* History of osteoporosis or osteopenia\n* Impaired circulation in the limb\n* Active deep vein thrombosis\n* Clotting disorders or other elevated risk of embolism\n* Sickle cell anemia\n* Infection in extremity\n* Renal compromise\n* Severe uncontrolled hypertension (SBP\\>180)\n* Lymphedema\n* Under age 18\n* Pregnancy\n* Prisoner",true,"ALL","18 Years","100 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.",[85,86],"Tibial Fractures","Lower Extremity Fracture","2025-11-18",{"date":89,"type":90},"2025-11-21","ACTUAL",{"date":92,"type":90},"2024-11-01",{"date":94,"type":79},"2026-05-31",{"name":5,"class":6},1]