NCT05725928

Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-05-15
• Primary completion: 2026-09-11
• Completion: 2026-10-11
• First posted: 2023-02-13
• Last updated: 2025-07-30

Locations

5 sites across 1 country: United States