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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoint(s) modified
    • Secondary endpoints revised (5)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07506720
Lead Sponsor Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborators: Medtronic Spine LLC
Conditions
(from sponsor)		 Spine, Post Surgery Patients, Recovery Method
Related terms Kinesiophobia
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov