Gait, UnsteadyCADENCENCT05886725
At-home Walking Cadence Functional Assessment and Recovery Trajectory for Older Adults Undergoing Major Surgery
An observational study of Gait, Unsteady, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gait, Unsteady
- What is being tested?
- Patients using Step Test Application and Accelerometer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Daniel Rubin, MD, 773-702-6856, drubin2@bsd.uchicago.edu
About this study
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.
Read the 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.
- Conditions
- Gait, Unsteady
- Being tested
- Patients using Step Test Application and Accelerometer
- Keywords
- Walking Cadence, Surgery, Older Adult, Smartphone, Accelerometer, Recovery trajectory, Functional capacity, Activity, Major abdominal surgery
- Medical subject headings
- Gait Disorders, Neurologic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Before surgery)
Secondary outcomes (5)
Change in disability, as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0: 12-item.
The simple sum of the scores of the 12-items range from 0 to 48 with higher scores indicating greater disability.
Measured: 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)?"
Interview question will be asked for 13 different tasks. An increased need for personal assistance demonstrates greater functional status decline.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline (Before surgery), 1 month after surgery, 3 months after surgery
Change in gait-cadence after surgery
Gait-cadence will be measured at-home after surgery from weekly at-home walking tests from smartphone
Measured: Weeks 1-8 after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start2 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, UnsteadyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rubin, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886725
- Sponsor's protocol ID
- IRB22-0556
- Acronym
- CADENCE
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-home Walking Cadence Functional Assessment and Recovery Trajectory for Older Adults Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT05886725
- Acronym / sponsor ID
- CADENCE / IRB22-0556
- Conditions
- Gait, Unsteady
- Keywords
- Walking Cadence, Surgery, Older Adult, Smartphone, Accelerometer, Recovery trajectory, Functional capacity, Activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients using Step Test Application and AccelerometerPatients 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. | Other | – |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
Change in gait-cadence after surgery
Time frame: Weeks 1-8 after surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Rubin principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait, Unsteady, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Rubin, MD (773-702-6856, drubin2@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of gait-cadence measured from at-home and in-clinic walk tests as measured by ActivPAL accelerometers. (time frame: Baseline (Before surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.