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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Functional Mobility [Срок оценки: Postoperative day 1 (after intervention) and postoperative day 2]

Вторичные конечные точки (5)

• Length of Hospital Stay [Срок оценки: From day of surgery to hospital discharge. Average of 4 days.]
• Kinesiophobia (Fear of Movement) [Срок оценки: Postoperative day 1 (before intervention and after intervention) and postoperative day 2]
• Time Spent in Bed [Срок оценки: 24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)]
• Pain Intensity [Срок оценки: Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2]
• Postoperative Complications [Срок оценки: Throughout study completion. Average of 1 year.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Montreal Sacred Heart Hospital — Montreal

Публикации

• Epstein NE. A review article on the benefits of early mobilization following spinal surgery and other medical/surgical procedures. Surg Neurol Int. 2014 Apr 16;5(Suppl 3):S66-73. doi: 10.4103/2152-7806.130674. eCollection 2014. PMID 24843814
• Qvarfordh P, Olsen KS, Bendix T, Esbensen BA. Should patients walk from the postanesthesia care unit to the general ward after a lumbar discectomy? A randomized study. J Perianesth Nurs. 2014 Oct;29(5):377-84. doi: 10.1016/j.jopan.2013.10.006. PMID 25261141
• Chakravarthy VB, Yokoi H, Coughlin DJ, Manlapaz MR, Krishnaney AA. Development and implementation of a comprehensive spine surgery enhanced recovery after surgery protocol: the Cleveland Clinic experience. Neurosurg Focus. 2019 Apr 1;46(4):E11. doi: 10.3171/2019.1.FOCUS18696. PMID 30933912
• Burgess LC, Wainwright TW. What Is the Evidence for Early Mobilisation in Elective Spine Surgery? A Narrative Review. Healthcare (Basel). 2019 Jul 18;7(3):92. doi: 10.3390/healthcare7030092. PMID 31323868
• Development of an Enhanced Recovery After Surgery (ERAS) approach for lumbar spinal fusion. J Neurosurg Spine. 2017 Apr;26(4):411-418. doi: 10.3171/2016.9.SPINE16375. Epub 2016 Dec 23. PMID 28009223
• Rupich K, Missimer E, O'Brien D, Shafer G, Wilensky EM, Pierce JT, Kerr M, Kallan MJ, Dolce D, Welch WC. The Benefits of Implementing an Early Mobility Protocol in Postoperative Neurosurgical Spine Patients. Am J Nurs. 2018 Jun;118(6):46-53. doi: 10.1097/01.NAJ.0000534851.58255.41. PMID 29794923
• Leditschke IA, Green M, Irvine J, Bissett B, Mitchell IA. What are the barriers to mobilizing intensive care patients? Cardiopulm Phys Ther J. 2012 Mar;23(1):26-9. PMID 22807652
• Cattanach N, Sheedy R, Gill S, Hughes A. Physical activity levels and patients' expectations of physical activity during acute general medical admission. Intern Med J. 2014 May;44(5):501-4. doi: 10.1111/imj.12411. PMID 24816309

Идентификаторы

NCT: NCT07506720 · 2020 - 2002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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