An interventional study of Standard Postoperative Care plus In-Bed Cycling in Spine, Post Surgery Patients and Recovery Method, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Not applicable, Interventional, and Treatment
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
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.
285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.
This study's planned enrollment of 88 is above the median of 52 across 174 interventional studies indexed under Kinesiophobia.
Browse Kinesiophobia studies →Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 34 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 obtained.
Exclusion Criteria
Non-ambulatory preoperatively.
(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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Postoperative day 1 (after intervention) and postoperative day 2
Length of Hospital Stay
Total duration of hospitalization in days from the date of surgery until hospital discharge.
Time frame: From day of surgery to hospital discharge. Average of 4 days.
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 frame: Postoperative day 1 (before intervention and after intervention) and postoperative day 2
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.
Time frame: 24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)
Pain Intensity
Pain intensity measured using the Visual Analog Scale (0-10). Pain is assessed at rest and during mobilization.
Time frame: Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2
Postoperative Complications
Occurrence of medical or surgical complications during hospitalization, including cardiopulmonary instability, neurological deficit, infection, or other adverse events.
Time frame: Throughout study completion. Average of 1 year.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — 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.
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