NCT05886725

Brief Summary

This is a prospective observational study looking at gait-cadence in older adults who are scheduled to have major abdominal surgery at the University of Chicago. The objective of the study is to evaluate whether gait-cadence, as measured from a patient's mobile device at-home, can provide an accurate assessment of a patient's functional status prior to major abdominal surgery and identify patients at risk of poor functional outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jan 2023Jun 2027

First Submitted

Initial submission to the registry

December 6, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

January 2, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

December 6, 2022

Last Update Submit

April 28, 2026

Conditions

Gait, Unsteady

Keywords

Walking CadenceSurgeryOlder AdultSmartphoneAccelerometerRecovery trajectoryFunctional capacityActivityMajor abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Accuracy of gait-cadence measured from at-home and in-clinic walk tests as measured by ActivPAL accelerometers.

    ActivPAL accelerometer will be worn during in-clinic walk tests to serve as reference of steps walked during the at-home walk tests.

    Baseline (Before surgery)

Secondary Outcomes (5)

  • Change in disability, as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0: 12-item.

    Baseline (Before surgery), 1 month after surgery, 3 months after surgery

  • Change in functional status, as measured by an interview in which participants will be asked, "At the present time, do you need help from another person to (complete the task)?"

    Baseline (Before surgery), 1 month after surgery, 3 months after surgery

  • Change in global health, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health.

    Baseline (Before surgery), 1 month after surgery, 3 months after surgery

  • Change in pain interference, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 6a.

    Baseline (Before surgery), 1 month after surgery, 3 months after surgery

  • Change in gait-cadence after surgery

    Weeks 1-8 after surgical procedure

Interventions

Patients using Step Test Application and AccelerometerOTHER

Patients who are scheduled to have surgery at University of Chicago Medical Center (UCMC) who agree to use the step test application and study accelerometer before and after their surgery.

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are 60 years or older who have surgery scheduled at University of Chicago that can walk independently with or without an assistive device.

You may qualify if:

  • Patients \> or = 60 years of age and scheduled for surgery.
  • Access to a safe walking space roughly 30 ft in length. Safe walking spaces include a long hallway in the home, common use hallway in an apartment building or outside public area.
  • Able to walk independently with or without an assistive device (e.g. cane or walker)

You may not qualify if:

  • Inability to walk independently
  • Surgery scheduled less than 7-days after APMC appointment
  • Patients scheduled for orthopedic surgery
  • Patients scheduled for neurological surgery
  • Patients scheduled for cardiac surgery
  • Non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Gait Disorders, NeurologicMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Daniel Rubin

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Rubin, MD

CONTACT

773-702-6856drubin2@bsd.uchicago.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

June 2, 2023

Study Start

January 2, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)