[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631902":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":22,"locations":28,"responsibleParty":45,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":12,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":12,"enrollmentInfo":62,"targetDuration":12,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":31,"whyStopped":12,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Postoperative Care","NO_INTERVENTION","Participants in this arm receive usual postoperative care following elective spine surgery, including standard nursing care and routine assistance with mobilization according to institutional practice. No in-bed cycling session is performed.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard Postoperative Care plus In-Bed Cycling","EXPERIMENTAL","Participants in this arm receive usual postoperative care following elective spine surgery plus a single supervised 30-minute in-bed cycling session on postoperative day 1. Cycling is performed using a portable ergometer in active or active-assisted mode under continuous physiological monitoring.",[18],"Other: Standard Postoperative Care plus In-Bed Cycling",[20],{"type":6,"name":14,"description":16,"armGroupLabels":21,"otherNames":12},[14],[23],{"name":24,"role":25,"phone":26,"phoneExt":12,"email":27},"Jean-Marc Mac-Thiong, M.D. P.h.D","CONTACT","(514) 338-2222","jean-marc.mac-thiong@umontreal.ca",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Montreal Sacred Heart Hospital","RECRUITING","Montreal","Quebec","H4J 1C5","Canada","CA",{"type":38,"coordinates":39},"Point",[40,41],-73.58781,45.50884,{"lat":41,"lon":40},[44],{"name":24,"role":25,"phone":26,"phoneExt":12,"email":27},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Jean-Marc Mac-Thiong","Principal Investigator, Orthopedic Surgeon",[50],{"name":51,"class":52},"Medtronic Spine LLC","INDUSTRY","100631902","early-mobilization-following-elective-spine-surgery-trial-of-in-bed-cycling-100631902",false,"NCT07506720","Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling","Early Mobilization Following Elective Spine Surgery: Prospective Randomized Trial of In-bed Cycling on Postoperative Day 1","Inclusion Criteria\n\nMale or female ≥ 18 years old.\n\nPostoperative #0 following elective spinal surgery: decompression with or without fusion, or fusion.\n\nPatient able to walk independently before surgery (does not require assistance from another person and does not use a wheelchair).\n\nPatient admitted directly from the operating room to the ward.\n\nHemodynamically stable:\n\nSystolic blood pressure (SBP): ≥ 90 mmHg and \\\u003C 140 mmHg\n\nOxygen saturation \\> 94%\n\nHeart rate: 50-100 bpm\n\nPatient approved for surgery after preoperative internal medicine evaluation.\n\nPatient alert and conscious.\n\nValid informed consent obtained.\n\nExclusion Criteria\n\nNon-ambulatory preoperatively.\n\nBody Mass Index (BMI) \\> 40 kg\u002Fm².\n\nAcute neurological spinal trauma.\n\nNon-neurological musculoskeletal impairment of the lower limbs (e.g., severe osteoarthritis, hip fracture, amputation) limiting the ability to pedal in bed.\n\nUncontrolled comorbidities preventing surgery or intervention (cardiovascular, respiratory, diabetes).\n\nExpected hospital stay of less than 2 days after surgery.\n\nSurgery-related complications: acute neurological deficit, dural tear, cerebrospinal fluid (CSF) leak, residual spinal instability.\n\nTransfer to intensive care unit or hemodynamic instability.\n\nPersistent hemodynamic instability: SBP \\\u003C 90 mmHg or \\> 200 mmHg, oxygen saturation \\\u003C 88%, heart rate \\\u003C 50 or \\> 100 bpm, temperature \\> 38°C.\n\nCapillary blood glucose outside target values: \\\u003C 4.0 or \\> 7.0 mmol\u002FL fasting or pre-meal, \\\u003C 5.0 and \\> 10.0 mmol\u002FL 2 hours post-meal.\n\nPatient confused, disoriented, or agitated.\n\nPatient already evaluated by physiotherapy for discharge planning or intensive functional rehabilitation.\n\nPatient in isolation.\n\nPatient already discharged.","ALL","18 Years",{"count":63,"type":64},88,"ESTIMATED","INTERVENTIONAL",[67],"NA","The goal of this clinical trial is to learn if early mobilization using an in-bed cycling device can reduce the amount of time patients spend in bed after elective spine surgery in adults.\n\nThe main questions it aims to answer are:\n\nDoes in-bed cycling on the day after surgery reduce the amount of time patients spend in bed over the next 24 hours?\n\nDoes in-bed cycling reduce the length of hospital stay and improve participation during physiotherapy assessment?\n\nResearchers will compare patients who receive an in-bed cycling session plus standard postoperative care to patients who receive standard postoperative care alone to see if early in-bed cycling improves mobility and recovery after spine surgery.\n\nParticipants will:\n\nBe randomly assigned to either a standard care group or an in-bed cycling group\n\nWear a fitness tracker to measure activity levels and time spent in bed\n\nReceive standard postoperative care\n\nComplete a 30-minute in-bed cycling session on the day after surgery (intervention group only)\n\nBe monitored for pain and vital signs during the study period\n\nUndergo a physiotherapy assessment to evaluate mobility and participation",[70,71,72],"Spine","Post Surgery Patients","Recovery Method",[74,75,76,77,78],"Spine Surgery","Postoperative Recovery","Early Mobilization","In-Bed Cycling","Kinesiophobia","2026-06-17",{"date":81,"type":82},"2026-06-22","ACTUAL",{"date":84,"type":82},"2025-08-01",{"date":86,"type":64},"2029-01",{"name":5,"class":6},1]