[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637196":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":31,"locations":42,"responsibleParty":66,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":30,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Toronto Rehabilitation Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Functional Electrical Stimulated Cycling","ACTIVE_COMPARATOR","Four FES-Cycling exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks.",[13],"Other: Functional Electrical Stimulated Cycling",{"label":15,"type":10,"description":16,"interventionNames":17},"Functional Electrical Stimulated Cycling with Blood Flow Restriction","Four FES-Cycling with BFR exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks.",[18,13],"Device: Blood Flow Restriction",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Blood Flow Restriction","Blood Flow Restriction (BFR) exercise is a training method where a specialized cuff or band is applied to the top of a limb (arm or leg) to partially restrict blood flow during exercise.",[15],[26],"KAATSU",{"type":6,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.",[9,15],null,[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Thomas P Walden, Ph.D","CONTACT","4165973422","6287","thomas.walden@uhn.ca",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Katherine Chan, MSc","6199","Katherine.chan@uhn.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Lyndhurst Centre","RECRUITING","Toronto","Ontario","M4G 3V9","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58,59,60,63],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},{"name":61,"role":62,"phone":30,"phoneExt":30,"email":30},"B.Catharine Craven, MD","PRINCIPAL_INVESTIGATOR",{"name":64,"role":65,"phone":30,"phoneExt":30,"email":30},"Kristin Musselman, Ph.D","SUB_INVESTIGATOR",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Dr. B. Catharine. Craven","Senior Scientist - Principal Investigator",[71],{"name":72,"class":73},"CAN-TAP-TALENT (CIHR Stream)","UNKNOWN","100637196","phase-1-fes-cycling-with-bfr-in-the-spinal-cord-injury-population-100637196",false,"NCT07588503","FES Cycling With BFR in the Spinal Cord Injury Population","Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population","Inclusion Criteria:\n\n* Adult (≥ 18 to ≤ 75yrs)\n* Male or female\n* Chronic Injury (\\>1yr)\n* Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology.\n* ≥3 Cardiometabolic risk parameters\n\nExclusion Criteria:\n\n* A prior or current history of venous thromboembolism\n* Pressure injury of the pelvis, mid to upper thigh region, or foot\n* Managing a lower limb fracture\n* Any history of embolic stroke\n* Myocardial infarction\n* Current untreated hypertension\n* Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and\u002For operate the device.\n* Current alcohol or street drug use disorder.\n* Current use of an anticoagulant medication.\n* Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).\n* Unresolved deep vein thromboembolism (VTE) in the past six months.\n* Severe spasticity preventing the necessary range of motion for cycling.\n* Active implantable medical device (e.g., pacemaker, ITB pump).\n* Inability to provide informed consent.\n* Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores).\n* Unstable spine or unhealed limbs or pelvic fractures.\n* Active heterotopic ossification interfering with the lower extremity range of motion.","ALL","18 Years","75 Years",{"count":85,"type":86},6,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury\u002Fdisease (SCI\u002FD) population. Many SCI\u002FD patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk. CMD contributes to 46% of deaths, with 30-50% of the SCI\u002FD population living with undiagnosed CMD. Treating CMD risk is more challenging in the SCI\u002FD population due to prolonged inactivity, inability to exercise, and excessive caloric intake to expenditure ratio. Identifying accessible and inclusive strategies to combat CMD risk in the SCI\u002FD population is a compelling and urgent health priority.\n\nBlood flow restriction (BFR) exercise involves applying inflatable cuffs to the proximal end of an individual's limbs. Changes to the amount of blood flowing into and out of the limb lead to a low oxygen environment within the limb, shifting the way the muscles can produce the energy required to function, increasing the benefits of low- and moderate-intensity exercise. Coupling BFR with Functional electrical stimulation cycling (FES-cycling), a commonly used rehabilitation tool within the SCI population, could improve FES-cycling's short- and long-term benefits without reducing the accessibility and inclusiveness of long-term exercise prescription. Although preliminary BFR research in the SCI\u002FD has identified positive muscular improvements, whether FES-cycling coupled with BFR can be safely prescribed or feasibly implemented long-term within the SCI\u002FD population is unknown.\n\nThe proposed project aims to determine the safety and feasibility of FES-cycling coupled with BFR for 20 minutes of moderate-intensity exercise among adults with chronic spinal cord injury\u002Fdisease (SCI\u002FD). The research team aims to implement pre-test, eight exercise sessions, and post-test across 6-weeks. Criteria for success include no adverse or severe adverse events not alleviated by ceasing exercise (safety), a 1 to 8 ratio of participants screened to participants eligible (recruitment success), and participants successfully completing all exercise sessions (participant retention).",[92,93,94],"Spinal Cord Injury","Cardio Vascular Disease","Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease",[96,97,92,98,99,100],"Safety","Feasability","Blood Flow Restricted Aerobic Exercise","Functional Electrical Stimulation","Cycling","2026-05-08",{"date":103,"type":104},"2026-05-14","ACTUAL",{"date":106,"type":86},"2026-06-15",{"date":108,"type":86},"2027-09-30",{"name":68,"class":6},1]