Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling

What this study is about

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. The main questions it aims to answer are: Does in-bed cycling on the day after surgery reduce the amount of time patients spend in bed over the next 24 hours? Does in-bed cycling reduce the length of hospital stay and improve participation during physiotherapy assessment? Researchers 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. Participants will: Be randomly assigned to either a standard care group or an in-bed cycling group Wear a fitness tracker to measure activity levels and time spent in bed Receive standard postoperative care Complete a 30-minute in-bed cycling session on the day after surgery (intervention group only) Be monitored for pain and vital signs during the study period Undergo a physiotherapy assessment to evaluate mobility and participation

Who can join (things the study team will check)

Inclusion Criteria Male or female ≥ 18 years old. Postoperative #0 following elective spinal surgery: decompression with or without fusion, or fusion. Patient able to walk independently before surgery (does not require assistance from another person and does not use a wheelchair). Patient admitted directly from the operating room to the ward. Hemodynamically stable: Systolic blood pressure (SBP): ≥ 90 mmHg and \< 140 mmHg Oxygen saturation \> 94% Heart rate: 50-100 bpm Patient approved for surgery after preoperative internal medicine evaluation. Patient alert and conscious. Valid informed consent obtained. Exclusion Criteria Non-ambulatory preoperatively. Body Mass Index (BMI) \> 40 kg/m². Acute neurological spinal trauma. Non-neurological musculoskeletal impairment of the lower limbs (e.g., severe osteoarthritis, hip fracture, amputation) limiting the ability to pedal in bed. Uncontrolled comorbidities preventing surgery or intervention (cardiovascular, respiratory, diabetes). Expected hospital stay of less than 2 days after surgery. Surgery-related complications: acute neurological deficit, dural tear, cerebrospinal fluid (CSF) leak, residual spinal instability…

Where this trial is running

• Montreal Sacred Heart Hospital, Montreal, Quebec, Canada

Who to contact

Jean-Marc Mac-Thiong, M.D. P.h.D · (514) 338-2222 · jean-marc.mac-thiong@umontreal.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07506720.