In-bed cycling to promote early mobilization after elective spine surgery.
Early Mobilization Following Elective Spine Surgery: Prospective Randomized Trial of In-bed Cycling on Postoperative Day 1
NA · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · NCT07506720
This study will test whether a 30-minute in-bed cycling session the day after elective spine surgery helps adults spend less time in bed and move more during recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07506720 on ClinicalTrials.gov |
What this trial studies
Adults having elective spine operations are randomly assigned to standard postoperative care alone or to standard care plus a single 30-minute in-bed cycling session on the day after surgery. Participants wear a fitness tracker to measure time spent in bed and overall activity, and researchers compare mobility, participation in physiotherapy, and length of hospital stay between groups. The trial enrolls ambulatory adults admitted directly from the operating room who meet basic hemodynamic and respiratory stability criteria. Outcomes focus on early postoperative activity over the first 24 hours and hospital recovery measures.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults (≥18 years) having elective spinal decompression or fusion who are admitted directly to the ward and are hemodynamically stable and alert after surgery.
Not a fit: Patients unlikely to benefit include those who were non-ambulatory before surgery, have acute spinal trauma, severe lower-limb impairment that prevents pedaling, BMI over 40, or unstable medical conditions that preclude safe participation.
Why it matters
Potential benefit: If successful, in-bed cycling could reduce time spent immobilized after surgery, support earlier participation in rehabilitation, and shorten hospital stays.
How similar studies have performed: Portable in-bed cycling has been shown to be safe and feasible in critically ill patients, but direct evidence for elective spine surgery is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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). 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 this trial is running
Montreal, Quebec
- Montreal Sacred Heart Hospital — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Jean-Marc Mac-Thiong, M.D. P.h.D
- Email: jean-marc.mac-thiong@umontreal.ca
- Phone: (514) 338-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spine, Post Surgery Patients, Recovery Method, Spine Surgery, Postoperative Recovery, Early Mobilization, In-Bed Cycling, Kinesiophobia