SpineNCT07506720
Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling
A study testing Standard Postoperative Care plus In-Bed Cycling in people with Spine and Post Surgery Patients, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine, Post Surgery Patients, Recovery Method
- What is being tested?
- Standard Postoperative Care plus In-Bed Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Sacred Heart Hospital
Montreal, Quebec, H4J 1C5
Jean-Marc Mac-Thiong, M.D. P.h.D, (514) 338-2222, jean-marc.mac-thiong@umontreal.ca
About this study
Official title: Early Mobilization Following Elective Spine Surgery: Prospective Randomized Trial of In-bed Cycling on Postoperative Day 1
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:
Read more
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
Read the detailed 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.
- Conditions
- Spine, Post Surgery Patients, Recovery Method
- Being tested
- Standard Postoperative Care plus In-Bed Cycling
- Keywords
- Spine Surgery, Postoperative Recovery, Early Mobilization, In-Bed Cycling, Kinesiophobia
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Postoperative Care plus In-Bed CyclingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard Postoperative Care plus In-Bed Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Mobility
Functional mobility assessed using the Five-Repetition Sit-to-Stand Test, which measures the time required to rise from a seated position to standing five consecutive times as quickly as possible. Shorter completion time indicates better lower-limb function and mobility.
Measured: Postoperative day 1 (after intervention) and postoperative day 2
Secondary outcomes (5)
Length of Hospital Stay
Total duration of hospitalization in days from the date of surgery until hospital discharge.
Measured: From day of surgery to hospital discharge. Average of 4 days.
Kinesiophobia (Fear of Movement)
Fear of movement assessed using the Tampa Scale for Kinesiophobia (French Canadian validated version). Higher scores indicate greater fear of movement.
Measured: Postoperative day 1 (before intervention and after intervention) and postoperative day 2
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.
Measured: 24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)
Pain Intensity
Pain intensity measured using the Visual Analog Scale (0-10). Pain is assessed at rest and during mobilization.
Measured: Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2
Postoperative Complications
Occurrence of medical or surgical complications during hospitalization, including cardiopulmonary instability, neurological deficit, infection, or other adverse events.
Measured: Throughout study completion. Average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Spine LLC
- Responsible party
- Principal investigator, Jean-Marc Mac-Thiong, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506720
- Sponsor's protocol ID
- 2020 - 2002
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been finalized. Decisions regarding IPD sharing will be made after study completion, taking into account participant consent and institutional policies.
Publications
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.
PubMed 24843814Qvarfordh 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.
PubMed 25261141Chakravarthy 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.
PubMed 30933912Burgess 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.
PubMed 31323868Development 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.
PubMed 28009223Rupich 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.
PubMed 29794923Leditschke 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.
PubMed 22807652Cattanach 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.
PubMed 24816309Brown 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.
PubMed 18712640Brown 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.
PubMed 15271112Anekwe 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.
PubMed 28355933
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization Following Elective Spine Surgery: Prospective Randomized Trial of In-bed Cycling on Postoperative Day 1
- ClinicalTrials.gov ID
- NCT07506720
- Acronym / sponsor ID
- 2020 - 2002
- Conditions
- Spine, Post Surgery Patients, Recovery Method
- Keywords
- Spine Surgery, Postoperative Recovery, Early Mobilization, In-Bed Cycling, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- Medtronic Spine LLC
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Standard Postoperative Care plus In-Bed CyclingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Systolic blood pressure (SBP): ≥ 90 mmHg and < 140 mmHg
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Postoperative Care plus In-Bed CyclingParticipants 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 |
Primary outcome
Functional Mobility
Time frame: Postoperative day 1 (after intervention) and postoperative day 2
Functional mobility assessed using the Five-Repetition Sit-to-Stand Test, which measures the time required to rise from a seated position to standing five consecutive times as quickly as possible. Shorter completion time indicates better lower-limb function and mobility.
5 secondary outcomes
Length of Hospital Stay
Time frame: From day of surgery to hospital discharge. Average of 4 days.
Kinesiophobia (Fear of Movement)
Time frame: Postoperative day 1 (before intervention and after intervention) and postoperative day 2
Time Spent in Bed
Time frame: 24 hours starting immediately after the intervention on postoperative day 1 (assessed between postoperative day 1 and postoperative day 2)
Pain Intensity
Time frame: Postoperative day 1 (before, during, and immediately after intervention) and postoperative day 2
Postoperative Complications
Time frame: Throughout study completion. Average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 24843814Epstein 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.
- Background: PubMed 25261141Qvarfordh 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.
- Background: PubMed 30933912Chakravarthy 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.
- Background: PubMed 31323868Burgess 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.
- Background: PubMed 28009223Development 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.
- Background: PubMed 29794923Rupich 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.
- Background: PubMed 22807652Leditschke 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.
- Background: PubMed 24816309Cattanach 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.
- Background: PubMed 18712640Brown 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.
- Background: PubMed 15271112Brown 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.
- Background: PubMed 28355933Anekwe 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.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been finalized. Decisions regarding IPD sharing will be made after study completion, taking into account participant consent and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Postoperative Care plus In-Bed Cycling in people with Spine and Post Surgery Patients, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Mac-Thiong, M.D. P.h.D ((514) 338-2222, jean-marc.mac-thiong@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Mobility (time frame: Postoperative day 1 (after intervention) and postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506720, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.