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Mobility LimitationNCT05725928

Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

A study testing Mobility technician in people with Mobility Limitation and Frailty, run by The Cleveland Clinic at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Mobility technician
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
5 sitesUnited States
Study dates
15 May 2023to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Participants must meet all of the inclusion criteria listed below to participate in this study:
  • ≥65 years of age
  • Admitted to a medical service
  • Complete history and physical examination on file
  • 6-Clicks score of 16-23
  • Insurance with Traditional Medicare or Medicare Advantage

Who cannot join

  • Any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:
  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Rothberg, M.D. contact

216-445-0719

rothbem@ccf.org

5 sites in 1 country

United States5 sites, 4 recruiting
  • Fairview Hospital

    Cleveland, Ohio, 44111

    Michael Rothberg, MD, 216-445-0719, rothbem@ccf.org

    Recruiting
  • Cleveland Clinic- Main Campus

    Cleveland, Ohio, 44195

    Michael Rothberg, MD, 216-445-0719, rothbem@ccf.org

    Recruiting
  • Marymount Hospital

    Garfield Heights, Ohio, 44125

    Terminated
  • Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

    Aaron Hamilton, MD, 440 312-3000, HAMILTA3@ccf.org

    Recruiting
  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Quinn Pack, MD, 413-794-7137, quinn.pack@baystatehealth.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Mobility technician
Medical subject headings
Mobility Limitation, Frailty, Iatrogenic Disease, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobility technicianBehavioural

    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.

Study groups in NCT05725928
Study groupRoleWhat they receive
Usual CareNo interventionNo intervention
Mobility TechnicianExperimentalDesignated 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
Receives: Behavioral: Mobility technician

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 10 days

Secondary outcomes (13)
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility

    Patients will complete the PROMIS physical function mobility bank via REDCap at 30 days post enrollment. PROMIS allows use of computer-adapted testing to measure patient-reported outcomes. The mobility question bank focuses on activities of physical mobility such as getting out of bed or a chair to walking up stairs. PROMIS measures were developed and validated with state-of-the-science methods supported by National Institutes of Health (NIH) funding. PROMIS was designed to enhance communication between clinicians and patients in diverse research and clinical settings and to be relevant across all conditions for the assessment of symptoms and functions.

    PROMIS minimum value= 0 PROMISE maximum value= 100 (higher score indicates a better outcome)

    Measured: 30 days post enrollment

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

    Subjects will complete the AM-PAC at 30 days post enrollment and the score will be transformed using the t-scale. In addition to comparing AM-PAC scores at 30 days, the investigator will also compare change in t-score from admission. The AM-PAC 6-clicks (assessed in the hospital) and the AM-PAC outpatient SF are normed to the same t-scale, allowing for conversion from the one to the other. The 6-clicks is scored by a clinical proxy, while the SF AM-PAC is self-reported, allowing for initial assessment by the MT and 30-day self-report by the patient. Previous studies have demonstrated adequate validity of mobility assessment via the AM-PAC using clinical or family proxies. To improve interpretability, investigators will compare the percentage of patients who reach the minimal clinically important difference of 3 points on the t-scale.

    AM-PAC minimum value= 29.41 AM-PAC maximum value= 80.30 (higher score indicates a better outcome)

    Measured: 30 days post enrollment

  3. Hospital-Acquired Complications

    Composite outcome of venous thromboembolism, fall with injury, pressure ulcers or hospital-acquired pneumonia. Hospital-acquired complications will be identified from the electronic health record and from the falls reporting system. All falls will be examined, whether occurring during assisted ambulation or otherwise. Only falls with injury will be included in the hospital-acquired complications measure. Outcomes will be adjudicated by blinded reviewers. While investigators are primarily interested in the composite measure, investigators will also examine the individual components separately.

    Measured: 10 days

  4. Number of Patients with Readmission within 30 days

    All cause readmission within 30 days of discharge from the index hospitalization.

    Measured: 30 days after discharge

  5. Activities of Daily Living

    Activities of daily living as measured by the Katz and Lawton scales.

    Katz minimum value= 0 Katz maximum value= 6 (higher score indicates a better outcome) Lawton minimum value= 0 Lawton maximum value= 8 (higher score indicates a better outcome)

    Measured: 30 days post enrollment

  6. Frailty

    Frailty as measured by the Fatigue, Resistance, Ambulation,Illness, and Loss of weight (FRAIL) scale.

    FRAIL minimum value= 0 FRAIL maximum value= 5 (higher score indicates a worse outcome)

    Measured: 30 days post enrollment

  7. Total episode cost

    Investigators will estimate total cost of the episode of care including the index admission (from hospital cost accounting systems), the personnel costs for the MTs (using hourly wages plus benefits), and all non-medication costs for the 30 days post-enrollment (from Medicare claims).

    Measured: Admission to 30 days post enrollment

  8. Number of Patients Discharged to Home

    Based on the discharge disposition in the medical record, investigators will identify whether the patient was discharged to home.

    Measured: date of randomization to date of discharge, up to 30 days

  9. Length of Stay

    Length of stay will be calculated as whole days from the time of admission to the time of discharge.

    Measured: date of admission to date of discharge, up to 30 days

  10. Mortality

    Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.

    Measured: 30 days from admission

  11. Total episode cost

    Investigators will estimate total cost of the episode of care including the index admission (from hospital cost accounting systems), the personnel costs for the MTs (using hourly wages plus benefits), and all non-medication costs for the 6 months post-enrollment (from Medicare claims).

    Measured: Admission to 6 months after enrollment

  12. Falls post-discharge

    Whether the patient has fallen, whether it was multiple times and whether an injury occurred will be assessed via telephone

    Measured: 30 days from admission

  13. RCSQ (Richards Campbell Sleep Questionnaire)

    Five question sleep survey which measures overall quality of sleep. Patients in both study arms will complete the questionnaire each morning regarding the previous night's sleep.

    Measured: Days 1-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start15 May 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05725928
Sponsor's protocol ID
22-426
Other IDs
1R01AG073278-01A1
Status last verified
Nov 2026
First submitted
11 Jan 2023
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24825244
  • 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.

    PubMed 19293070
  • 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.

    PubMed 21314647
  • Corcoran PJ. Use it or lose it--the hazards of bed rest and inactivity. West J Med. 1991 May;154(5):536-8.

    PubMed 1866946
  • 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.

    PubMed 6955965
  • 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.

    PubMed 2123911
  • 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.

    PubMed 8629876
  • 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.

    PubMed 19682121
  • 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.

    PubMed 10737280
  • 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.

    PubMed 2738307
  • 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.

    PubMed 21098357
  • 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.

    PubMed 16481783
  • 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.

    PubMed 37488588

Questions about this trial

What is this clinical trial studying?

A study testing Mobility technician in people with Mobility Limitation and Frailty, run by The Cleveland Clinic at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Rothberg, M.D. (216-445-0719, rothbem@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Short Physical Performance Battery (SPPB) from admission (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05725928, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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