Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific exercise program can help improve balance and mobility in patients with moderate asymptomatic carotid artery stenosis (ACAS). ACAS means that there is a narrowing of the carotid arteries, which supply blood to the brain, but the patients do not have any symptoms yet. The study aims to see if a supervised exercise routine, which includes aerobic activities and balance challenges, can make a difference in how well these patients move and maintain their balance. This is important because poor balance can lead to falls, which are a major risk for older adults.

To participate in this study, individuals must be at least 18 years old and have 50-69% narrowing of their carotid arteries without any previous strokes or serious health issues that would prevent them from exercising. Participants will engage in the exercise program and will be monitored to see how it affects their balance and mobility. This trial could significantly help improve the quality of life for many Veterans at risk of falls and related injuries. If you're interested in being part of this study or know someone who might be, please reach out for more information!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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