Recruiting

Supervised Ambulation

Sponsor:

The Cleveland Clinic

Code:

NCT05725928

Conditions

Mobility Limitation

Frailty

Hospital Acquired Condition

Weakness, Muscle

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Mobility technician

Study Details

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.

Conditions

Mobility Limitation

Frailty

Hospital Acquired Condition

Weakness, Muscle

Study ID

NCT05725928

Start date

May 15, 2023

Status verified date

Jun, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to participate in this study:

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:

Any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:

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

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Usual Care

No intervention

experimental: 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

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.

Primary outcome measure

  • Change in Short Physical Performance Battery (SPPB) from admission [ Time Frame: Up to 10 days ]

Central Contacts and Locations

Central contacts

Michael Rothberg, M.D.

216-445-0719rothbem@ccf.org

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Quinn Pack, MD

413-794-7137quinn.pack@baystatehealth.org

Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Michael Rothberg, MD

216-445-0719rothbem@ccf.org

Cleveland Clinic- Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Michael Rothberg, MD

216-445-0719rothbem@ccf.org

Marymount Hospital

Recruiting

Garfield Heights, Ohio, United States, 44125

Contacts

Michael Rothberg, MD

216-445-0719rothbem@ccf.org

Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Aaron Hamilton, MD

440 312-3000HAMILTA3@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-08.