Clinical trial for Spine
Official title Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling
ClinicalTrials.gov ID: NCT07506720
What this study is testing
- What it's testing
- This study wants to find out if riding a special bike in bed the day after surgery helps patients spend less time in bed and leave the hospital sooner.
- Who it's for
- This study is looking for adults who are scheduled to have elective spine surgery.
- What's involved
- Participants will wear a fitness tracker to track their activity. Some will also do a 30-minute session on a bike that fits in the bed the day after surgery, while everyone receives standard care.
- Time commitment
- The study involves monitoring during the hospital stay and a physical therapy check-up to see how well you are moving.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
- Systolic blood pressure (SBP): ≥ 90 mmHg and \< 140 mmHg
You likely can't join 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...
- Uncontrolled comorbidities preventing surgery or intervention (cardiovascular, respiratory, diabetes).
- Expected hospital stay of less than 2 days after surgery.
See the full eligibility 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.
- 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.
- 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 \ 200 mmHg, oxygen saturation \ 100 bpm, temperature \> 38°C.
- Capillary blood glucose outside target values: \ 7.0 mmol/L fasting or pre-meal, \ 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.