Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

NCT05725928 | Recruiting DMC

• 2 other identifiers: 22-4261R01AG073278-01A1
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery (SPPB) from admission

  Every patient will have an SPPB score on admission to the study. A blinded assessor will measure the SPPB again at discharge or on day 10 if the patient is still hospitalized. The primary outcome is change from admission to discharge. Investigators will also compare the percentage of patients who reach the minimal clinically important difference of 1 point. SPPB minimum value= 0 SPPB maximum value= 12 (higher score indicates a better outcome). If no blinded team member is available, the evaluation may be carried out by any unblinded team member. The blinding status of the evaluator will be noted in REDCap.

  Up to 10 days

Secondary Outcomes (13)

• Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility

  30 days post enrollment

• Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)

  30 days post enrollment

• Hospital-Acquired Complications

  10 days

• Number of Patients with Readmission within 30 days

  30 days after discharge

• Activities of Daily Living

  30 days post enrollment

Study Arms (2)

Usual Care

NO INTERVENTION

No intervention

Mobility Technician

EXPERIMENTAL

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

Behavioral: Mobility technician

Interventions

Mobility technician 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.

Mobility Technician

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years of age
• Admitted to a medical service
• Complete history and physical examination on file
• Clicks score of 16-23
• Insurance with Traditional Medicare or Medicare Advantage

You may not qualify if:

• Significant language barrier that requires a translator (other than Spanish at Baystate site only)
• Discharge planned for that day or the following day
• Observation status
• Surgical procedure planned
• Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation
• Permanent residence in a skilled nursing facility
• Comfort care measures only
• \>48 hours since admission
• Active infection with COVID-19
• Other active infection requiring contact or droplet precautions
• Order for bedrest

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (5)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Fairview Hospital

Cleveland, Ohio, 44111, United States

RECRUITING

Cleveland Clinic- Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

Marymount Hospital

Garfield Heights, Ohio, 44125, United States

RECRUITING

Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

RECRUITING

Related Publications (13)

• Suter LG, Li SX, Grady JN, Lin Z, Wang Y, Bhat KR, Turkmani D, Spivack SB, Lindenauer PK, Merrill AR, Drye EE, Krumholz HM, Bernheim SM. 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. J Gen Intern Med. 2014 Oct;29(10):1333-40. doi: 10.1007/s11606-014-2862-5. Epub 2014 May 14.

  PMID: 24825244 BACKGROUND

• Brown CJ, Roth DL, Allman RM, Sawyer P, Ritchie CS, Roseman JM. Trajectories of life-space mobility after hospitalization. Ann Intern Med. 2009 Mar 17;150(6):372-8. doi: 10.7326/0003-4819-150-6-200903170-00005.

  PMID: 19293070 BACKGROUND

• Zisberg A, Shadmi E, Sinoff G, Gur-Yaish N, Srulovici E, Admi H. Low mobility during hospitalization and functional decline in older adults. J Am Geriatr Soc. 2011 Feb;59(2):266-73. doi: 10.1111/j.1532-5415.2010.03276.x.

  PMID: 21314647 BACKGROUND

• Corcoran PJ. Use it or lose it--the hazards of bed rest and inactivity. West J Med. 1991 May;154(5):536-8.

  PMID: 1866946 BACKGROUND

• Gillick MR, Serrell NA, Gillick LS. Adverse consequences of hospitalization in the elderly. Soc Sci Med. 1982;16(10):1033-8. doi: 10.1016/0277-9536(82)90175-7.

  PMID: 6955965 BACKGROUND

• Hirsch CH, Sommers L, Olsen A, Mullen L, Winograd CH. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990 Dec;38(12):1296-303. doi: 10.1111/j.1532-5415.1990.tb03451.x.

  PMID: 2123911 BACKGROUND

• Sager MA, Franke T, Inouye SK, Landefeld CS, Morgan TM, Rudberg MA, Sebens H, Winograd CH. Functional outcomes of acute medical illness and hospitalization in older persons. Arch Intern Med. 1996 Mar 25;156(6):645-52.

  PMID: 8629876 BACKGROUND

• Brown CJ, Redden DT, Flood KL, Allman RM. The underrecognized epidemic of low mobility during hospitalization of older adults. J Am Geriatr Soc. 2009 Sep;57(9):1660-5. doi: 10.1111/j.1532-5415.2009.02393.x. Epub 2009 Aug 4.

  PMID: 19682121 BACKGROUND

• Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.

  PMID: 10737280 BACKGROUND

• Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112.

  PMID: 2738307 BACKGROUND

• Fisher SR, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010 Nov 22;170(21):1942-3. doi: 10.1001/archinternmed.2010.422. No abstract available.

  PMID: 21098357 BACKGROUND

• Graf C. Functional decline in hospitalized older adults. Am J Nurs. 2006 Jan;106(1):58-67, quiz 67-8. doi: 10.1097/00000446-200601000-00032.

  PMID: 16481783 BACKGROUND

• Johnson JK, Hamilton AC, Hu B, Pack QR, Lindenauer PK, Fox RJ, Hashmi A, Siegmund LA, Burchill CN, Taksler GB, Goto T, Stilphen M, Rothberg MB. Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial. Trials. 2023 Jul 24;24(1):471. doi: 10.1186/s13063-023-07501-y.

  PMID: 37488588 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Frailty; Iatrogenic Disease; Muscle Weakness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Disease Attributes; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Michael Rothberg, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Rothberg, M.D.

CONTACT

216-445-0719; rothbem@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research, Primary Care Institute

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 13, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): October 11, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (5)