Using pedometers and coaching to improve walking after major surgery
A Randomized, Controlled Trial to Evaluate if Pedometer-Guided Coaching Can Promote Postoperative Ambulation After Abdominopelvic Surgeries
This study is testing if using a pedometer along with virtual coaching can help people recover better and walk more after major abdominal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT06259591 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of remote pedometer follow-up combined with virtual coaching to enhance ambulation in patients recovering from major abdominopelvic surgery. Participants will be randomly assigned to either receive only pedometer follow-up or additional coaching via text messages to encourage walking. The study will assess whether this coaching improves adherence to ambulation recommendations and leads to better postoperative outcomes, including satisfaction and reduced complications. Participants will use a pedometer app to track their activity levels during the recovery period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older undergoing major abdominopelvic surgery with a planned inpatient stay of at least one night.
Not a fit: Patients undergoing liver or upper gastrointestinal surgery, or those unable to walk at baseline, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and reduce complications for patients after major surgery.
How similar studies have performed: Previous studies have shown that inpatient pedometer-guided exercise programs can improve postoperative ambulation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult subjects ≥18 years at screening * Subjects undergoing major abdominopelvic surgery under general anesthesia, expected to last more than 3 hours from induction of anesthesia to anesthesia stop time. * Able to understand the study procedures and voluntarily provide study informed consent * Agree to be followed up for the duration of the study period * Has access to a smart phone with app compatibility * Planned inpatient stay for 1 night or more Exclusion Criteria: * Subjects undergoing liver surgery or upper gastrointestinal surgery * Refusal to install the app/ deleted app before end of the monitor period * Subjects who are unable to walk at baseline * Medical contraindications for unrestricted ambulation * Patients with spinal or lower limb pathology, chronic or poorly controlled pain potentially preventing full postoperative ambulation * Neurological impairment precluding unrestricted ambulation Cognitive impairment precluding consent or follow up study activities * BMI \>40 * Patients who require any mobility aid at baseline * Subjects discharged to a rehab facility or never discharged from the hospital alive * Hospital length of stay \> 1 week * Patient not cleared by physical therapy for unrestricted ambulation on discharge
Where this trial is running
Stony Brook, New York
- Stony Brook University Hospital — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sergio D Bergese, MD, FASA — Stony Brook Medicine
- Study coordinator: Alexa Christophides, MHA
- Email: alexa.christophides@stonybrookmedicine.edu
- Phone: 6314442939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.