NCT05725928 Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
| NCT ID | NCT05725928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Mobility Limitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,000 participants in total. It began in 2023-05-15 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michael Rothberg, M.D.
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT05725928 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mobility Limitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05725928 currently recruiting?
Yes, NCT05725928 is actively recruiting participants. Contact the research team at rothbem@ccf.org for enrollment information.
Where is the NCT05725928 trial being conducted?
This trial is being conducted at Springfield, United States, Cleveland, United States, Cleveland, United States, Garfield Heights, United States and 1 additional location.
Who is sponsoring the NCT05725928 clinical trial?
NCT05725928 is sponsored by The Cleveland Clinic. The principal investigator is Michael Rothberg, M.D. at The Cleveland Clinic. The trial plans to enroll 3,000 participants.