NCT07506720 Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling
| NCT ID | NCT07506720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
| Condition | Spine |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-08 |
Trial Parameters
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Brief Summary
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
Eligibility Criteria
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). Expecte