Pedometer Coaching to Promote Postoperative Ambulation

RECRUITING

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The goal of this randomized controlled trial is to evaluate whether remote pedometer follow-up and virtual coaching can improve ambulation after major abdominopelvic surgery, and how this affects key postoperative outcomes. The main questions it aims to answer are: * Does pedometer-guided ambulation coaching increases ambulation after surgery? * Does pedometer-guided coaching improve satisfaction, quality of recovery, while reducing postoperative complications? Participants will be asked to install a pedometer app for the purpose of data sharing. Study personnel will compare pedometer follow-up plus text message coaching (intervention) with pedometer follow-up only (control) to investigate whether coaching improves adherence to the postoperative ambulation recommendation, and whether this leads to improvement of the secondary outcomes.

Conditions:

🦠 Postoperative Outcomes

🗓️ Study Start (Actual) 31 January 2023

🗓️ Primary Completion (Estimated) June 2024

✅ Study Completion (Estimated) August 2024

👥 Enrollment (Estimated) 120

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Stony Brook, New York, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 11 January 2024
First Submitted that Met QC Criteria 6 February 2024
First Posted 14 February 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 6 February 2024
Last Update Posted 14 February 2024
Last Verified February 2024