Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
Healthy Volunteers
NCT05436600

Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Led by VA Office of Research and Development · Updated on 2026-03-04

50

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Moderate (50-69%) asymptomatic carotid artery stenosis (ACAS) is an important and under-appreciated contributor to balance and mobility dysfunction. This is significant because declines in balance and mobility are a significant predictor of falls, disability, loss of independence, and death in older adults. Further, falls and fall-related injuries in older adults cost approximately 50 billion dollars annually in the United States, and are the leading cause of adverse events reported by the Veterans Health Administration. This proposal seeks to: 1) investigate the impact of a supervised aerobic and challenging balance exercise program on balance and mobility function in patients with moderate ACAS; and 2) elucidate whether these changes are related to changes in cerebral perfusion. With 830,000 Veterans estimated to have moderate ACAS and at risk for balance and mobility dysfunction and increased falls, the findings from this study could have significant impacts on the clinical management, quality of life, and functional independence of Veterans with moderate ACAS.

CONDITIONS

Official Title

Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Who Can Participate

Age: 18Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Have 50-69% asymptomatic carotid artery stenosis confirmed by medical history, physical exam, and NIH Stroke Scale
  • Stenosis severity confirmed by duplex sonography, MR angiography, or CT angiography
Not Eligible

You will not qualify if you...

  • Previous stroke or transient ischemic attack
  • Occlusion or severe stenosis of the non-index carotid artery
  • Planned carotid revascularization
  • Advised by doctor not to exercise
  • Medical condition preventing walking or exercise or likely to reduce follow-up
  • Medical condition increasing risk of injury from testing or intervention
  • Orthostatic hypotension
  • Severe illness interfering with outcome evaluation
  • Uncorrected visual impairment or recent eye surgery (within 6 months)
  • Allergy to gadolinium contrast or renal insufficiency preventing PW-MRI
  • History of dementia, cognitive impairment, or inability to follow commands
  • Other neurological conditions such as Parkinson's, peripheral neuropathy, myopathy
  • Use of sedative medications
  • Major depression (CES-D score >16)
  • Ability to complete 10-second Single Leg Stance Test without losing balance on either side
  • Regular structured aerobic exercise more than three times per week within one month before study start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

S

Sarasijhaa K Desikan, MD

CONTACT

K

Kimberlly A Nordstrom

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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