Pedometer Coaching to Promote Postoperative Ambulation

February 6, 2024 updated by: Sergio D. Bergese, Stony Brook University

A Randomized, Controlled Trial to Evaluate if Pedometer-Guided Coaching Can Promote Postoperative Ambulation After Abdominopelvic Surgeries

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ambulation is not only a key component for improved postoperative recovery, studies have also found associations between the degree of ambulation in the early postoperative period and postoperative morbidity. Additionally, A preoperative sedentary lifestyle has been associated with a higher incidence of complications and readmissions after surgery . Our team conducted a systematic review, which found that perioperative pedometer readings were captured in 64-94% of the patients, and pedometer data were linked to a number of important perioperative outcomes including; complications; length of stay; and unplanned readmission. Several studies have demonstrated that inpatient pedometer-guided exercise programs could improve postoperative ambulation. However, this is limited by the length of hospital stay. In this study, the aim is to investigate the efficacy of pedometer-based coaching for post-discharge ambulation.

This is a randomized controlled trial with a 1:1 allocation ratio. Participants will be randomly allocated to either pedometer follow-up (control) or pedometer follow-up with 3 times per week ambulation coaching through texts (intervention). Participants will be screened and consented before surgery. All recruited subjects will have a pedometer app installed on their phone during the preoperative clinic visit, during which the purpose of the app and potential risks will be explained.

After surgery and confirmation of the postoperative criteria, participants will enter the study and undergo randomization through a automated system.

Postoperatively , participants in the control arm will have pedometer data collected over postoperative days 8-30. The participants in the interventional arm will also have the pedometer data collected, while additionally being provided feedback in the form of text message every Monday, Wednesday and Friday.

Pedometer data:

The pedometer app utilized for this study is called "Outwalk" and it is designed by a third party. The study team has a research account on the pedometer app. During the screening visit, after downloading the app and creating the deidentified study subject account, the subject enables their data to be shared with the research account. This provides automatic access to the step count data. The study team will have access to subject data and the unblinded team member will check the steps count.

The following details will be collected from the medical record and/or directly from the participants: Age, Gender , Race and Ethnicity, Planned surgery, American Society of Anesthesiologists (ASA) classification, Insurance status, BMI, Charlson comorbidity score, smoking status (never, former, current), alcohol status (never, social, regular), substance use disorder (yes or no), reports of postoperative delirium, unplanned admissions to emergency room or unplanned hospital visits after surgery,

The following are collected from the participants: Postoperative recovery satisfaction (1-10), Sleep quality (1-10), pre and postoperative Duke Activity Status Index (0-58.2), technical issues with pedometer or app use (no, or yes with explanation), Quality of Recovery 15 score (0-150)

Sample size:

Based on prior findings from prior studies, this study is expected to enroll 120 subjects (60 subjects per arm), accounting for loss to follow-up or restrictions of primary outcome. In an inpatient exercising program for patients undergoing laparoscopic surgery, the intervention increased step goal adherence from 7% to 27% with a sample size of 58 subjects per arm, Using 1:1 allocation with p<0.05 and power of 80%. In another study of open gynecology procedures; results showed the proportion of patients achieving activity goal (return to preoperative baseline) was 71% with pedometer-- based exercise intervention vs 41% control, with a sample size of 42 subjects per arm.

Participants who have missing data on more than 30% of the days will be removed from the study, their data will not be analyzed. Participants who have zero steps recorded for more than 30% of the days will also be treated as out-of-range results and will not be included in the primary analysis.

The investigation team plan to evaluate the distribution of the baseline characteristics between the two arms. Additional statistical analyses will be undertaken if there is significant baseline characteristics imbalance. Participants who have missing baseline data will be included in the primary and secondary analyses. The plan is to conduct a separate sensitivity analysis with these participants excluded. Participants with missing day 30 data will be included in the primary analyses. For such participants , any usable day-30 data will be included in the secondary analyses.

The primary analysis will compare the compliance with the ambulation goal between the coaching arm and the pedometer only arm. Compliance is defined as achieving at least 90% of the recommended ambulation goal (>2,250 steps per day), this is to accommodate for daily variation in activities, as well as to accommodate for missed step recording.

For the evaluation of secondary outcomes, the day 30 outcomes between the coaching arm and the pedometer follow-up arm will be compared. Additionally, the following exploratory analyses are planned:

  1. Day-30 outcomes in participants who reached the ambulation goal compared to those who did not, including participants in both arms
  2. Comparing the changes in daily step count across time from day 8 to day 30
  3. Sensitivity analysis of primary outcome, where participants with out-of-range results will be included.
  4. Sensitivity analysis of primary outcome, where participants with missing baseline data will be excluded.

Participants who have missing baseline data will be included in the primary and secondary analyses. A separate sensitivity analysis will be conducted with these patients excluded.

Participants with missing day 30 data will be included in the primary analyses. For such participants, any usable day-30 data will be included in the secondary analyses.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pedometer follow-up and coaching
Pedometer follow-up plus text message coaching Monday/ Wednesday/ Friday
Behavioral: 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.
Behavioral: 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.
Active Comparator: Pedometer follow up
Pedometer follow-up from day 8- 30 after surgery
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to ambulation goal
Time Frame: Postoperative day 8 to day 30
Proportion of days on which patient met the ambulation goal
Postoperative day 8 to day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Duke Activity Status Index (DASI) score
Time Frame: Postoperative day 8 to day 30
DASI score obtained through patient interview. This is a score which can range from 0 to 58.2. Higher score denotes better self-reported functional capacity.
Postoperative day 8 to day 30
30-day Quality of Recovery -15 (QoR-15) score
Time Frame: Postoperative day 8 to day 30
QoR-15 score obtained through patient interview. This is a score which can range from 0-150. Higher score denotes better self-reported recovery after surgery.
Postoperative day 8 to day 30
Unplanned hospital visits
Time Frame: Postoperative day 8 to day 30
Emergency room or hospital visits which are not part of the planned postoperative follow up visits, obtained through medical record review and patient interview
Postoperative day 8 to day 30
Sleep
Time Frame: Postoperative day 8 to day 30
Quality of sleep. This is reported using a self-reported numerical rating scale which ranges from 0 to 10. Higher score denotes better sleep quality.
Postoperative day 8 to day 30
Patient satisfaction
Time Frame: Postoperative day 8 to day 30
Patient satisfaction with the postoperative recovery. This is reported using a self-reported numerical rating scale which ranges from 0 to 10. Higher score denotes better satisfaction.
Postoperative day 8 to day 30
Postoperative delirium
Time Frame: Day of surgery to day of discharge (up to 7 days after surgery)
Report of postoperative delirium during the hospital stay
Day of surgery to day of discharge (up to 7 days after surgery)
Technical issue with the app or the follow up
Time Frame: Postoperative day 8 to day 30
Patient reported issue with the pedometer app usage or the follow up process, obtained through patient interview
Postoperative day 8 to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Sergio D Bergese, MD, FASA, Stony Brook Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB2022-00574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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