Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID05725928

Randomized Trial of Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Led by The Cleveland Clinic · Updated on 2026-06-08

3000

Participants Needed

5

Research Sites

4 weeks

Total Duration

On this page

Sponsors

T

The Cleveland Clinic

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a randomized trial to study the effects of supervised walking, led by specially trained mobility technicians (MTs), on hospitalized medical patients aged 65 and older. The study aims to compare health outcomes and costs between patients receiving this assisted ambulation and those receiving usual care. It also seeks to identify which patients benefit most and assess the financial impact of the intervention over the hospital stay and 30 days afterward. Patients enrolled in the trial will be randomly assigned to either receive usual care or to have mobility technicians help them walk up to three times daily, every day including weekends, during their hospital stay for up to 10 days. The MTs will visit patients multiple times a day to encourage and assist with walking based on individual mobility scores and physical therapy recommendations, if available. All participants will wear wrist accelerometers to track their movement throughout their hospital stay. Participants will be closely monitored with various assessments including the Short Physical Performance Battery (SPPB) to measure mobility at discharge or after 10 days, and additional follow-ups at 30 days post enrollment to assess physical function, frailty, hospital complications, readmissions, and daily living activities. Researchers will also evaluate total costs related to the hospital stay and 30 days afterward. The study lasts up to 30 days per participant with ongoing safety and outcome monitoring.

CONDITIONS

Brief Title

Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 65 years of age or older
  • Admitted to a medical hospital service
  • Complete history and physical examination on file
  • 6-Clicks mobility score between 16 and 23
  • Insurance with Traditional Medicare or Medicare Advantage
Not Eligible

You will not qualify if you...

  • Significant language barrier requiring a translator (except Spanish at Baystate site)
  • Discharge planned for today or the following day
  • Observation status patients
  • Surgical procedure planned
  • Unstable angina or medical conditions preventing exercise/ambulation
  • Permanent residence in a skilled nursing facility
  • Comfort care measures only
  • More than 48 hours since hospital admission
  • Active COVID-19 infection
  • Other active infections requiring contact or droplet precautions
  • Ordered bedrest during hospitalization

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 days or until hospital discharge

Participants receive supervised ambulation up to 3 times daily with a Mobility Technician during their hospital stay, up to a maximum of 10 days. Ambulation is based on participant mobility scores and recommendations from physical therapists when available.

Daily visits up to 10 days during hospitalization

Follow-up

Duration - 30 days post enrollment, with some outcomes tracked up to 6 months

Participants are monitored for health outcomes such as physical function, readmission, activities of daily living, frailty, and mortality for 30 days after enrollment. Costs and other health events are also tracked up to 6 months.

Follow-up assessments up to 30 days, with some data collected up to 6 months

Trial Site Locations

Total: 5 locations

1

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

2

Fairview Hospital

Cleveland, Ohio, United States, 44111

Actively Recruiting

3

Cleveland Clinic- Main Campus

Cleveland, Ohio, United States, 44195

Actively Recruiting

4

Marymount Hospital

Garfield Heights, Ohio, United States, 44125

Actively Recruiting

5

Hillcrest Hospital

Mayfield Heights, Ohio, United States, 44124

Actively Recruiting

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Research Team

M

Michael Rothberg, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

National patterns of risk-standardized mortality and readmission after hospitalization for acute myocardial infarction, heart failure, and pneumonia: update on publicly reported outcomes measures based on the 2013 release.

Lisa G Suter, Shu-Xia Li, Jacqueline N Grady...

https://pubmed.ncbi.nlm.nih.gov/24825244