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

NCT07506720 | Recruiting

• 1 other identifier: 2020 - 2002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spine; Post Surgery Patients; Recovery Method

Keywords

Spine Surgery; Postoperative Recovery; Early Mobilization; In-Bed Cycling; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)

Secondary Outcomes (5)

• Length of Hospital Stay

  From day of surgery to hospital discharge. Average of 4 days.

• Functional Mobility

  Postoperative day 1 (after intervention) and postoperative day 2

• Kinesiophobia (Fear of Movement)

  Postoperative day 1 (before intervention and after intervention) and postoperative day 2

• Pain Intensity

  Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2

• Postoperative Complications

  Throughout study completion. Average of 1 year.

Study Arms (2)

Standard Postoperative Care

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Standard Postoperative Care plus In-Bed Cycling OTHER

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.

Standard Postoperative Care plus In-Bed Cycling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Medtronic Spine LLC: collaborator

Study Sites (1)

Montreal Sacred Heart Hospital

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Brown CJ, Roth DL, Allman RM. Validation of use of wireless monitors to measure levels of mobility during hospitalization. J Rehabil Res Dev. 2008;45(4):551-8. doi: 10.1682/jrrd.2007.06.0086.

  PMID: 18712640 BACKGROUND

• Brown CJ, Friedkin RJ, Inouye SK. Prevalence and outcomes of low mobility in hospitalized older patients. J Am Geriatr Soc. 2004 Aug;52(8):1263-70. doi: 10.1111/j.1532-5415.2004.52354.x.

  PMID: 15271112 BACKGROUND

• Anekwe DE, Koo KK, de Marchie M, Goldberg P, Jayaraman D, Spahija J. Interprofessional Survey of Perceived Barriers and Facilitators to Early Mobilization of Critically Ill Patients in Montreal, Canada. J Intensive Care Med. 2019 Mar;34(3):218-226. doi: 10.1177/0885066617696846. Epub 2017 Mar 7.

  PMID: 28355933 BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Central Study Contacts

Jean-Marc Mac-Thiong, M.D. P.h.D

CONTACT

(514) 338-2222; jean-marc.mac-thiong@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthopedic Surgeon

Model Details: This is a prospective, randomized, single-blind, parallel-group interventional study. Eligible participants are randomly assigned in a 1:1 ratio to either a control group receiving standard postoperative care or an intervention group receiving standard postoperative care plus a supervised in-bed cycling session on postoperative day 1. Randomization is performed using a computer-generated allocation sequence by an independent biostatistician.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: April 2, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CA (1)