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

March 28, 2026 updated by: Jean-Marc Mac-Thiong, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Here is a ClinicalTrials.gov-style Detailed Description written from your protocol. It is technical, structured, and avoids duplicating eligibility criteria or outcome tables while expanding beyond a brief summary.

Detailed Description

Early mobilization after surgery is recognized as a safe and effective strategy to reduce postoperative complications and functional decline. In patients undergoing spine surgery, early mobilization has been associated with shorter hospital stays, improved functional recovery, and fewer complications such as pneumonia, thromboembolism, and deconditioning. Despite these benefits, a large proportion of hospitalized patients remain in bed for most of their stay, particularly older adults. Barriers to mobilization include limited physiotherapy resources, patient fear of movement, and concerns among healthcare staff regarding safety.

In current practice, mobilization after elective spine surgery often depends on availability of physiotherapy services, which may be delayed until postoperative day 2 or 3. As a result, many patients remain inactive during the first postoperative day, a period that may be critical for preventing deconditioning. Interventions that enable safe, early, and resource-efficient mobilization are therefore needed.

In-bed cycling using a portable ergometer has been shown to be safe and feasible in critically ill patients, including those receiving mechanical ventilation. This approach allows active or assisted lower-limb movement without requiring the patient to stand or walk, thereby overcoming several common barriers to early mobilization. However, the effectiveness of in-bed cycling as a mobilization strategy has not previously been evaluated in patients undergoing elective spine surgery.

This study is a prospective, randomized, single-blind clinical trial designed to evaluate whether a single session of in-bed cycling performed on postoperative day 1 reduces time spent in bed compared with standard postoperative care alone. Participants are randomized to either a control group receiving usual postoperative mobilization or an intervention group receiving usual care plus a supervised 30-minute in-bed cycling session on postoperative day 1.

All participants receive standard postoperative management, including assistance with transfer to a chair on postoperative day 1. Participants wear a wrist-based activity monitor continuously until postoperative day 2 to objectively quantify mobility and time spent in bed. Additional assessments include pain, fear of movement (kinesiophobia), and functional mobility tests. Physiotherapy assessments determining discharge readiness are conducted independently and blinded to group allocation.

For the intervention group, the in-bed cycling session is conducted under close supervision by trained research staff. Participants are positioned in semi-recumbent posture with appropriate monitoring of heart rate, blood pressure, and oxygen saturation throughout the session. Cycling is performed in active or active-assisted mode, targeting a cadence of approximately 40 revolutions per minute, with gradual warm-up and cool-down phases. Pain and perceived exertion are assessed during the session, and predefined safety criteria allow immediate termination if physiological instability or patient discomfort occurs.

The primary aim of the trial is to determine whether early mobilization through in-bed cycling reduces time spent in bed during the 24 hours following the intervention. Secondary objectives include evaluating effects on hospital length of stay, functional mobility, kinesiophobia, and participation in physiotherapy. A short interim safety analysis is planned after the inclusion of an initial subset of participants to confirm tolerability and feasibility.

Data are collected using coded identifiers to ensure confidentiality. Activity monitor data are stored separately from clinical data to preserve blinding during analysis. Statistical analyses follow the intention-to-treat principle, with comparisons between groups performed using appropriate parametric tests. Multivariable analyses may be used to adjust for baseline differences if needed.

By introducing a simple, low-resource mobilization strategy early after surgery, this study aims to promote patient autonomy, reduce immobility, and potentially shorten hospital stays following elective spine surgery. If effective, in-bed cycling could represent a scalable and practical adjunct to standard postoperative care in spine surgery units.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Postoperative Care
Participants in this arm receive usual postoperative care following elective spine surgery, including standard nursing care and routine assistance with mobilization according to institutional practice. No in-bed cycling session is performed.
Experimental: Standard Postoperative Care plus In-Bed Cycling
Participants 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.
Other: Standard Postoperative Care plus In-Bed Cycling
Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Spent in Bed
Time Frame: 24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)
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.
24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: From day of surgery to hospital discharge. Average of 4 days.
Total duration of hospitalization in days from the date of surgery until hospital discharge.
From day of surgery to hospital discharge. Average of 4 days.
Functional Mobility
Time Frame: Postoperative day 1 (after intervention) and postoperative day 2
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.
Postoperative day 1 (after intervention) and postoperative day 2
Kinesiophobia (Fear of Movement)
Time Frame: Postoperative day 1 (before intervention and after intervention) and postoperative day 2
Fear of movement assessed using the Tampa Scale for Kinesiophobia (French Canadian validated version). Higher scores indicate greater fear of movement.
Postoperative day 1 (before intervention and after intervention) and postoperative day 2
Pain Intensity
Time Frame: Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2
Pain intensity measured using the Visual Analog Scale (0-10). Pain is assessed at rest and during mobilization.
Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2
Postoperative Complications
Time Frame: Throughout study completion. Average of 1 year.
Occurrence of medical or surgical complications during hospitalization, including cardiopulmonary instability, neurological deficit, infection, or other adverse events.
Throughout study completion. Average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Medtronic Spine LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 - 2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan for sharing individual participant data (IPD) has not yet been finalized. Decisions regarding IPD sharing will be made after study completion, taking into account participant consent and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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