Recruiting

Pedometer Coaching

Sponsor:

Stony Brook University

Code:

NCT06259591

Conditions

Postoperative Outcomes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pedometer follow-up

Ambulation coaching

Study Details

Brief summary:

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 ID

NCT06259591

Start date

Jan 31, 2023

Status verified date

Feb, 2024

Completion date

Aug, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pedometer follow-up and coaching

Pedometer follow-up plus text message coaching Monday/ Wednesday/ Friday

active comparator: Pedometer follow up

Pedometer follow-up from day 8- 30 after surgery

Interventions

Pedometer follow-up

The daily step count will be obtained from the patients using a pedometer app (OutWalk) from day 8 to day 30 after surgery.

Ambulation coaching

Patients will receive coaching text messages every Monday, Wednesday and Friday between day 8 and day 30 after surgery, based on a pre-fixed template.

Primary outcome measure

  • Adherence to ambulation goal [ Time Frame: Postoperative day 8 to day 30 ]

Central Contacts and Locations

Central contacts

Alexa Christophides, MHA

6314442939alexa.christophides@stonybrookmedicine.edu

Zhaosheng Jin, MBBS

6318067909zhaosheng.jin@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Alexa Christophides, MHA

631-444-2939alexa.christophides@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Feb 14, 2024

Last verified

Feb, 2024

Keywords

  • Wearable Electronic Devices
  • Ambulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2024-02-14.