Early Mobilization Following Elective Spine Surgery: Prospective Randomized Trial of In-bed Cycling on Postoperative Day 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Standard Postoperative Care plus In-Bed Cycling (Other)
研究者
Jean-Marc Mac-Thiong
Principal Investigator, Orthopedic Surgeon
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal