Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07506720

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

Led by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Updated on 2026-04-02

88

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

Sponsors

C

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

Lead Sponsor

M

Medtronic Spine LLC

Collaborating Sponsor

AI-Summary

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 18 years old or older
  • Undergoing elective spinal surgery (decompression with or without fusion, or fusion)
  • Able to walk independently before surgery without assistance or wheelchair
  • Admitted directly from operating room to the ward
  • Hemodynamically stable with systolic blood pressure between 90 and 140 mmHg
  • Oxygen saturation above 94%
  • Heart rate between 50 and 100 beats per minute
  • Approved for surgery after preoperative internal medicine evaluation
  • Alert and conscious
  • Provided valid informed consent
Not Eligible

You will not qualify if you...

  • Not able to walk independently before surgery
  • Body Mass Index over 40 kg/m²
  • Acute neurological spinal trauma
  • Severe lower limb musculoskeletal impairments limiting ability to pedal in bed (e.g., severe osteoarthritis, hip fracture, amputation)
  • Uncontrolled cardiovascular, respiratory, or diabetes conditions preventing surgery or intervention
  • Expected hospital stay less than 2 days after surgery
  • Surgery complications such as acute neurological deficit, dural tear, cerebrospinal fluid leak, or residual spinal instability
  • Transfer to intensive care unit or hemodynamic instability
  • Persistent hemodynamic instability with abnormal blood pressure, oxygen saturation, heart rate, or high temperature
  • Abnormal blood glucose levels outside target ranges
  • Confusion, disorientation, or agitation
  • Already evaluated by physiotherapy for discharge or intensive rehabilitation
  • Patient in isolation
  • Already discharged

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Montreal Sacred Heart Hospital

Montreal, Quebec, Canada, H4J 1C5

Actively Recruiting

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Research Team

J

Jean-Marc Mac-Thiong, M.D. P.h.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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