Recruiting

In-Bed Cycling

Sponsor:

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Code:

NCT07506720

Conditions

Spine

Post Surgery Patients

Recovery Method

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Postoperative Care plus In-Bed Cycling

Study Details

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

Study ID

NCT07506720

Start date

Aug 1, 2025

Status verified date

Mar, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

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

Locations

Montreal Sacred Heart Hospital

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

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

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

More Information

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Last update posted

Jun 22, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal on 2026-06-22.