[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524978":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":9,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":30,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Medisch Spectrum Twente","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"T-REX Twente","EXPERIMENTAL","The intervention group receives the new T-REX Twente precautions, allowing for more independent activities through the use of the tube model (keeping elbows close to the sides).",[13],"Behavioral: T-REX Twente precautions",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","ACTIVE_COMPARATOR","The control group is not allowed to lift, push, or pull for the first 6 weeks. There is little to no evidence for the current strict precautions currently implemented in the department.",[19],"Behavioral: Usual (restrictive) sternal precautions",[21,27],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","T-REX Twente precautions",[9],[26],"The T-REX Twente precautions are inspired on the Keep Your Move in the Tube (KYMITT) principle, and adjusted and improved to our local setting",{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"Usual (restrictive) sternal precautions",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Frank R. Halfwerk, MD, PhD","Medisch Spectrum Twente, Enschede, the Netherlands","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Nicole Wielens, BSc","CONTACT","0031615060570","n.wielens@mst.nl",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Thoraxcentrum Twente","RECRUITING","Enschede","Overijssel","7500KA","Netherlands","NL",{"type":52,"coordinates":53},"Point",[54,55],6.89583,52.21833,{"lat":55,"lon":54},[58,59,62],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},{"name":60,"role":39,"phone":30,"phoneExt":30,"email":61},"Frank R Halfwerk, MD, PhD","f.halfwerk@mst.nl",{"name":63,"role":64,"phone":30,"phoneExt":30,"email":30},"Kim Roerdink, MSc","SUB_INVESTIGATOR",{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Frank Halfwerk","Assistant Professor and Technical Medical Doctor in Cardio-Thoracic Surgery",[69],{"name":70,"class":6},"Foothills Medical Centre","100524978","rct-on-t-rex-twente-regimen-effects-on-quality-of-life-and-mobilisation-for-cardiac-surgery-patients-after-sternotomy-100524978",false,"NCT06115759","RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy","A Randomized Clinical Trial to Study the \"T-REX Twente Regimen\" (Thoracic Surgery Rehabilitation Experts Twente) on Quality of Life and Mobilisation Activities for Cardiac Surgery Patients After Median Sternotomy, Compared to Usual Care","Inclusion Criteria:\n\n* Adult patients who are preoperatively included if they are undergoing a total median sternotomy at Thorax Centrum Twente (TCT)\n* Patients with their treating cardiologist also working for TCT.\n\nExclusion Criteria:\n\n* \\>72 hours of admission to the Intensive Care Unit (ICU)\n* Postoperative delirium (diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) version V\n* Patients with dementia (or other significant cognitive disorders)\n* Dutch language barriers\n* Patients with a cardiologist from a location other than TCT","ALL","18 Years",{"count":81,"type":82},154,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this study is whether the T-REX Twente precautions have a positive impact on the quality of life (MAcNew QLMI), level of physical activity, and reduction of fear of movement in heart patients after a total median sternotomy compared to the (current) standard precautions? Do these precautions also have no adverse effects on pain, wound healing, and\u002For postoperative complications?\n\nParticipants will be instructed by the physiotherapist to both groups immediately postoperatively and are constantly repeated by the involved disciplines during the hospital stay.\n\nThe control group is not allowed to lift, push, or pull for the first 6 weeks. There is little to no evidence for the current strict precautions currently implemented in the department.\n\nThe intervention group receives the new T-REX Twente precautions, allowing for more independent activities through the use of the tube model (keeping elbows close to the sides).\n\nAll patients receive three questionnaires (MacNew QLMI, Numeric Pain Rating Scale, and Tampa Scale for Kinesiophobia) preoperatively, on the 4th day postoperatively, on the first day of cardiac rehabilitation, and at the end of cardiac rehabilitation, taking approximately 10 minutes each time. Additionally, during the clinical admission immediately postoperatively, two AX3 accelerometers are placed on the patient, one lateroproximal on the right upper arm and one anterodistal on the right upper leg.\n\nResearchers will compare heart patients after a total median sternotomy with T-REX Twente precautions (intervention group) to the (current) standard precautions (control group).",[88,89,90,91,92],"Sternotomy","Cardiovascular Diseases","Physical Inactivity","Quality of Life","Surgery",[88,94,95,96],"Cardiac Surgical Procedures","Cardiac Rehabilitation","Early Ambulation","2025-02-05",{"date":99,"type":100},"2025-02-07","ACTUAL",{"date":102,"type":100},"2024-05-21",{"date":104,"type":82},"2026-03",{"name":5,"class":6},1]