Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

NCT ID: NCT05725928

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-10-11

Brief Summary

The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.

Detailed Description

The investigator proposes to conduct a large randomized trial to test the impact of MTs (Mobility Technicians) on short and intermediate term outcomes for 3000 patients aged 65 years and older at 5 hospitals in 2 health systems. Patients will be randomized to receive supervised ambulation up to 3 times daily with a MT or to receive usual care. All participants will wear an accelerometer on their wrist to track their movement throughout the hospital stay. The study has 3 aims. First, the study will compare the mobility of patients at discharge (or 10 days) to assess the impact of the MTs on this outcome. Of particular interest is whether the use of MTs will increase the proportion of patients who can go home vs.post-acute care, and whether the improvements in mobility are sustained at 30 days. Second, the study will use predictive modeling to identify which patients are most likely to benefit from this intervention. Third, the study will assess the impact of the intervention on overall costs associated with the episode of care, including inpatient costs and the 30 days post enrollment. This information will be important to convince health systems to adopt this approach.

Conditions

Mobility Limitation; Frailty; Hospital Acquired Condition; Weakness, Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mobility Technician

Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session

Group Type: EXPERIMENTAL

Mobility technician

Intervention Type: BEHAVIORAL

Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session.

Interventions

Mobility technician

Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ≥65 years of age

2. Admitted to a medical service

3. Complete history and physical examination on file

4. 6-Clicks score of 16-23

5. Insurance with Traditional Medicare or Medicare Advantage

Exclusion Criteria

1. Significant language barrier that requires a translator (other than Spanish at Baystate site only)

2. Discharge planned for that day or the following day

3. Observation status

4. Surgical procedure planned

5. Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation

6. Permanent residence in a skilled nursing facility

7. Comfort care measures only

8. >48 hours since admission

9. Active infection with COVID-19

10. Other active infection requiring contact or droplet precautions

11. Order for bedrest

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael Rothberg

Vice Chair for Research, Primary Care Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Rothberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status: RECRUITING

Fairview Hospital

Cleveland, Ohio, United States

Site Status: RECRUITING

Cleveland Clinic- Main Campus

Cleveland, Ohio, United States

Site Status: RECRUITING

Marymount Hospital

Garfield Heights, Ohio, United States

Site Status: RECRUITING

Hillcrest Hospital

Mayfield Heights, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Rothberg, M.D.

Role: CONTACT

rothbem@ccf.org

216-445-0719

Facility Contacts

Quinn Pack, MD

Role: primary

quinn.pack@baystatehealth.org

413-794-7137

Michael Rothberg, MD

Role: primary

rothbem@ccf.org

216-445-0719

Michael Rothberg, MD

Role: primary

rothbem@ccf.org

216-445-0719

Michael Rothberg, MD

Role: primary

rothbem@ccf.org

216-445-0719

Aaron Hamilton, MD

Role: primary

HAMILTA3@ccf.org

440-312-3000

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Other Identifiers

1R01AG073278-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-426

Identifier Type: -

Identifier Source: org_study_id