Overview
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
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.
Eligibility
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.
