Pedometer Coaching to Promote Postoperative Ambulation

NCT06259591 | Recruiting

• 1 other identifier: IRB2022-00574
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Wearable Electronic Devices; Ambulation

Outcome Measures

Primary Outcomes (1)

• Adherence to ambulation goal

  Proportion of days on which patient met the ambulation goal

  Postoperative day 8 to day 30

Secondary Outcomes (7)

• 30-day Duke Activity Status Index (DASI) score

  Postoperative day 8 to day 30

• 30-day Quality of Recovery -15 (QoR-15) score

  Postoperative day 8 to day 30

• Unplanned hospital visits

  Postoperative day 8 to day 30

• Sleep

  Postoperative day 8 to day 30

• Patient satisfaction

  Postoperative day 8 to day 30

Study Arms (2)

Pedometer follow-up and coaching

EXPERIMENTAL

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

Behavioral: Pedometer follow-up; Behavioral: Ambulation coaching

Pedometer follow up

ACTIVE COMPARATOR

Pedometer follow-up from day 8- 30 after surgery

Behavioral: Pedometer follow-up

Interventions

Pedometer follow-up BEHAVIORAL

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

Pedometer follow up; Pedometer follow-up and coaching

Ambulation coaching BEHAVIORAL

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.

Pedometer follow-up and coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (7)

• Hedrick TL, Hassinger TE, Myers E, Krebs ED, Chu D, Charles AN, Hoang SC, Friel CM, Thiele RH. Wearable Technology in the Perioperative Period: Predicting Risk of Postoperative Complications in Patients Undergoing Elective Colorectal Surgery. Dis Colon Rectum. 2020 Apr;63(4):538-544. doi: 10.1097/DCR.0000000000001580.

  PMID: 32015289 BACKGROUND

• Nakajima H, Yokoyama Y, Inoue T, Nagaya M, Mizuno Y, Kayamoto A, Nishida Y, Nagino M. How Many Steps Per Day are Necessary to Prevent Postoperative Complications Following Hepato-Pancreato-Biliary Surgeries for Malignancy? Ann Surg Oncol. 2020 May;27(5):1387-1397. doi: 10.1245/s10434-020-08218-x. Epub 2020 Jan 23.

  PMID: 31974713 BACKGROUND

• Bille A, Buxton J, Viviano A, Gammon D, Veres L, Routledge T, Harrison-Phipps K, Dixon A, Minetto MA. Preoperative Physical Activity Predicts Surgical Outcomes Following Lung Cancer Resection. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420975853. doi: 10.1177/1534735420975853.

  PMID: 33835869 BACKGROUND

• Jin Z, Lee C, Zhang K, Jeong R, Gan TJ, Richman DC. Utilization of Wearable Pedometer Devices in the Perioperative Period: A Qualitative Systematic Review. Anesth Analg. 2023 Apr 1;136(4):646-654. doi: 10.1213/ANE.0000000000006353. Epub 2023 Mar 16.

  PMID: 36928149 BACKGROUND

• Wolk S, Linke S, Bogner A, Sturm D, Meissner T, Mussle B, Rahbari NN, Distler M, Weitz J, Welsch T. Use of Activity Tracking in Major Visceral Surgery-the Enhanced Perioperative Mobilization Trial: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Jun;23(6):1218-1226. doi: 10.1007/s11605-018-3998-0. Epub 2018 Oct 8.

  PMID: 30298422 BACKGROUND

• van Dijk-Huisman HC, Weemaes ATR, Boymans TAEJ, Lenssen AF, de Bie RA. Smartphone App with an Accelerometer Enhances Patients' Physical Activity Following Elective Orthopedic Surgery: A Pilot Study. Sensors (Basel). 2020 Aug 2;20(15):4317. doi: 10.3390/s20154317.

  PMID: 32748876 BACKGROUND

• No JH, Kim K, Kim YB, Suh DH, Yang EJ, Hwang H, Yoo S. Effects of an activity tracker with feedback on physical activity in women after midline laparotomy: A randomized controlled trial. J Obstet Gynaecol Res. 2021 Jul;47(7):2544-2550. doi: 10.1111/jog.14807. Epub 2021 Apr 25.

  PMID: 33899302 BACKGROUND

Study Officials

• Sergio D Bergese, MD, FASA

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa Christophides, MHA

CONTACT

6314442939; alexa.christophides@stonybrookmedicine.edu

Zhaosheng Jin, MBBS

CONTACT

6318067909; zhaosheng.jin@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Pedometer data collection and coaching text administration will be done by an unmasked team member. 30-day interview will be done by a masked team member.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Outcomes and Clinical Research in Perioperative Medicine

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 14, 2024
• Study Start: January 31, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)