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.
