Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07506720

Early Mobilization Following Elective Spine Surgery: Prospective Randomized Trial of In-bed Cycling on Postoperative Day 1

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

21 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

Researchers are evaluating whether early use of an in-bed cycling device can reduce the time adult patients spend in bed after elective spine surgery. This randomized, single-blind clinical trial aims to see if cycling on the day after surgery decreases bed rest time within 24 hours, shortens hospital stays, and improves participation in physiotherapy assessments. Early mobilization is important to prevent complications and promote recovery following spine surgery.

CONDITIONS

Brief 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 including decompression with or without fusion, or fusion
  • Able to walk independently before surgery without assistance or wheelchair
  • Admitted directly from the operating room to the ward
  • Hemodynamically stable with systolic blood pressure between 90 and 140 mmHg
  • Oxygen saturation greater than 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...

  • Non-ambulatory before surgery
  • Body mass index over 40 kg/m²
  • Acute neurological spinal trauma
  • Severe musculoskeletal impairments of lower limbs limiting pedaling (e.g., severe osteoarthritis, hip fracture, amputation)
  • Uncontrolled cardiovascular, respiratory, or diabetic conditions preventing surgery or intervention
  • Expected hospital stay less than 2 days after surgery
  • Surgery-related complications such as acute neurological deficit, dural tear, cerebrospinal fluid leak, or spinal instability
  • Transfer to intensive care or hemodynamic instability
  • Persistent unstable vital signs including abnormal blood pressure, oxygen saturation, heart rate, or fever
  • Abnormal blood glucose levels outside target ranges
  • Confusion, disorientation, or agitation
  • Already evaluated by physiotherapy for discharge or intensive rehabilitation
  • Patient in isolation or already discharged

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo elective spine surgery followed by admission to the ward.

1 visit (in-person)

Treatment

Duration - Postoperative day 1

Participants receive standard postoperative care. Those in the intervention group also have a single supervised 30-minute in-bed cycling session on postoperative day 1 to promote early mobilization.

1 inpatient visit on postoperative day 1

Post-operative Follow-up

Duration - Up to postoperative day 2

Participants wear a wrist-based activity monitor continuously until postoperative day 2. Additional assessments of pain, fear of movement, and functional mobility are conducted. Physiotherapy assessments determine discharge readiness.

1 to 2 visits for assessments

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for postoperative complications and length of hospital stay. Follow-up may continue for up to one year to assess safety and recovery outcomes.

Periodic assessments depending on clinical course

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

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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Published Research Related To This Trial

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Pernilla Qvarfordh, Karsten Skovgaard Olsen, Tom Bendix...

https://pubmed.ncbi.nlm.nih.gov/25261141

Development and implementation of a comprehensive spine surgery enhanced recovery after surgery protocol: the Cleveland Clinic experience.

Vikram B Chakravarthy, Hana Yokoi, Daniel J Coughlin...

https://pubmed.ncbi.nlm.nih.gov/30933912