RecruitingNot ApplicableNCT07506720

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

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Enrollment

88 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Spine Post Surgery Patients Recovery Method

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

Min Age: 18 Years

Inclusion Criteria11

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 Criteria14

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.
Transfer to intensive care unit or hemodynamic instability.
Persistent hemodynamic instability: SBP \< 90 mmHg or \> 200 mmHg, oxygen saturation \< 88%, heart rate \< 50 or \> 100 bpm, temperature \> 38°C.
Capillary blood glucose outside target values: \< 4.0 or \> 7.0 mmol/L fasting or pre-meal, \< 5.0 and \> 10.0 mmol/L 2 hours post-meal.
Patient confused, disoriented, or agitated.
Patient already evaluated by physiotherapy for discharge planning or intensive functional rehabilitation.
Patient in isolation.
Patient already discharged.

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Interventions

OTHERStandard Postoperative Care plus In-Bed Cycling

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.