Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention
Recruiting now · Not applicable
Conditions studied: Asymptomatic Carotid Stenosis (50-69%), Mobility Impairment
In brief
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.
Key facts
- Study ID
- NCT05436600
- Run by
- VA Office of Research and Development
- People needed
- 50
- Starts
- 2022-10-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Eligible patients will be at least 18 years of age and will have asymptomatic 50-69% carotid stenosis
- Asymptomatic status will be confirmed as in NIH trials on asymptomatic carotid stenosis, by medical history, physical examination, and the National Institutes of Health Stroke Scale (NIHSS)
- Stenosis severity will be determined by duplex sonography, MR angiography, or CT angiography
You may not qualify if…
- previous stroke or transient ischemic attack
- occlusion or severe stenosis of the non-index carotid artery
- planned carotid revascularization
- persons advised by their doctor not to exercise
- a medical condition that precludes the ability to ambulate
- exercise or reduces the likelihood of follow-up
- evidence of a medical condition that would lead to an increased risk of accident, injury, or illness as a result of the proposed testing or intervention
- orthostatic hypotension
- severe medical illness that interferes with the evaluation of outcomes
- uncorrected visual impairment or eye surgery in the past 6 months
- patients that are unable to undergo PW-MRI due to gadolinium contrast allergy or renal insufficiency will also be excluded
- given the possibility that comorbid cognitive impairment may influence balance and mobility function, subjects with any documented medical history of dementia or cognitive impairment or those unable to follow commands will be excluded from the study
- In addition, subjects with other neurological conditions such as Parkinson's, peripheral neuropathy or myopathy, sedative medications, and major depression (Center for Epidemiological Studies Depression Survey Score >16) will be excluded
- in order to avoid ceiling effects of the Mini BESTest, potential subjects will be prescreened for balance dysfunction using a 10-second Single Leg Stance Test
- those that are able to complete the test without losing balance on either side will be excluded from the study
- the investigators will exclude subjects that participate in structured aerobic exercise routinely greater than three times per week within a month of starting the study
Where it is running
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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