At-home Walking Cadence Functional Assessment and Recovery Trajectory for Older Adults Undergoing Major Surgery (CADENCE)

April 28, 2026 updated by: University of Chicago
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Over 100,000 older adults undergo elective major abdominal surgeries in the US each year and many experience loss of mobility after surgery that requires post-acute care. Risk of mobility loss is greater for older adults unable to engage in moderate-intensity physical activity before surgery. Additionally, recovery trajectories to baseline mobility remains poorly understood for older adults and may impact readmission. Functional status assessment before surgery can identify interventions to help older adults improve walking capacity and improve recovery trajectories after surgery. However, almost no patients receive objective functional status tests before surgery due to logistical and practical barriers. Remote assessments performed independently by the patient using wearable technology, such as smartphones, may provide a solution. Smartphone accelerometers combined with open-source software can directly measure a patient's gait-cadence, or the number of steps taken per minute. This observational cohort of older adults undergoing major abdominal surgery will use a novel smartphone application to obtain remotely collected gait-cadence from usual and fast paced walks prior to their in-clinic visit. Investigators will then compare the at-home to the in-clinic usual and fast paced walks and measure their recovery trajectory after surgery through weekly at-home walks. Overall mobility will be assessed using ActiGraph accelerometers worn for a 7-day time period before and after surgery. The investigator's hypothesis is that gait-cadence measured during usual and fast pace walks at-home will 1) provide an accurate and easy to use functional assessment 2) identify patients at-risk of mobility loss and 3) determine walking recovery trajectories for older adults after surgery. Results from this study will provide important knowledge on mobility trajectories of older adults after major abdominal surgery and develop a novel approach to identify high-risk older adults. Further, this platform may be leveraged to deliver mobility interventions before surgery to improve patient outcomes after surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University Of Chicago Medical Center
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of gait-cadence measured from at-home and in-clinic walk tests as measured by ActivPAL accelerometers.
Time Frame: Baseline (Before surgery)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in disability, as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0: 12-item.
Time Frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
The simple sum of the scores of the 12-items range from 0 to 48 with higher scores indicating greater disability.
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)?"
Time Frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Interview question will be asked for 13 different tasks. An increased need for personal assistance demonstrates greater functional status decline.
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.
Time Frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Total raw scores are between 4 and 20, and these can be converted to a T-score. Higher scores mean more of the concept being measured. For example, higher scores mean more 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.
Time Frame: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Total raw score ranges from 6 to 30, and these can be converted to a T-score. Higher scores indicate greater pain interference on relevant aspects of a participant's life.
Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Change in gait-cadence after surgery
Time Frame: Weeks 1-8 after surgical procedure
Gait-cadence will be measured at-home after surgery from weekly at-home walking tests from smartphone
Weeks 1-8 after surgical procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Rubin, University of Chicago

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB22-0556

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

product manufactured in and exported from the U.S.

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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