Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling
Recruiting · NCT07506720 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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 take part
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
- xygen 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.
- 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.
Where it is running
1 location listed.
- Montreal Sacred Heart Hospital - Montreal, Quebec, Canada