88 Participants NeededMy employer runs this trial

In-Bed Cycling for Post-Surgical Recovery

JM
Overseen ByJean-Marc Mac-Thiong, M.D. P.h.D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I have just had planned spinal surgery for decompression and/or fusion.
I am 18 years old or older.
Hemodynamically stable: SBP ≥ 90 mmHg and < 140 mmHg, Oxygen saturation > 94%, Heart rate: 50-100 bpm
See 5 more

Exclusion Criteria

I am unable to walk before surgery.
Body Mass Index (BMI) > 40 kg/m²
Patient in isolation
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard postoperative care with or without a 30-minute in-bed cycling session on postoperative day 1

1 day
In-hospital stay

Follow-up

Participants are monitored for pain, mobility, and time spent in bed using a wrist-based activity monitor until postoperative day 2

2 days
Continuous monitoring

Postoperative Monitoring

Participants are assessed for functional mobility, kinesiophobia, and postoperative complications

4 days

What Are the Treatments Tested in This Trial?

Interventions

  • In-bed Cycling

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Standard Postoperative Care plus In-Bed CyclingExperimental Treatment1 Intervention
Group II: Standard Postoperative CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
17
Recruited
4,600+

Medtronic Spine LLC

Industry Sponsor

Trials
13
Recruited
1,700+