About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Standard Postoperative Care plus In-Bed Cycling
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Functional Mobility
Functional mobility assessed using the Five-Repetition Sit-to-Stand Test, which measures the time required to rise from a seated position to standing five consecutive times as quickly as possible. Shorter completion time indicates better lower-limb function and mobility.
Secondary outcomes
Length of Hospital Stay
Total duration of hospitalization in days from the date of surgery until hospital discharge.
Kinesiophobia (Fear of Movement)
Fear of movement assessed using the Tampa Scale for Kinesiophobia (French Canadian validated version). Higher scores indicate greater fear of movement.
Time Spent in Bed
Total time spent in bed over a 24-hour period, measured objectively using a wrist-worn activity monitor with accelerometer and step-counting capabilities. The device distinguishes time spent lying in bed from time spent active or walking. This outcome reflects overall postoperative mobility and the effectiveness of early in-bed cycling as a mobilization strategy.
Pain Intensity
Pain intensity measured using the Visual Analog Scale (0-10). Pain is assessed at rest and during mobilization.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead sponsor
Medtronic Spine LLC
Collaborator