Exercise for Asymptomatic Carotid Stenosis and Mobility

This study is looking at how a special exercise program, called AeroBal, might help people with moderate asymptomatic carotid stenosis (a narrowing of the neck arteries that doesn't cause symptoms) who also have trouble with balance and movement. The AeroBal exercise program involves 12 weeks of supervised aerobic and balance exercises, about three times a week. Researchers want to see if this program can improve your balance and ability to move around. You could be eligible if you are between 18 and 89 years old and have 50-69% asymptomatic carotid stenosis. The study aims to enroll 50 participants, but the current status of enrollment is unclear.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to either the exercise group or a control group. The study plans to enroll 50 participants.
What's involved
If you join, you would either participate in 12 weeks of supervised AeroBal exercise training (about 3 times a week) or receive standard care. Before and after, you would have assessments including balance and mobility tests.
Compensation
Not stated in the trial record.
Follow-up
Your balance and mobility will be measured again at 12 weeks after starting the intervention.

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NCT05436600

Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Recruiting
NAAges 18–89InterventionalTreatment
VA Office of Research and Development
~50 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Exercise Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Mini BESTest score
Measured over Baseline to 12 weeks
Asymptomatic Carotid Stenosis (50-69%)
Mobility Impairment
1 sites across 1 states
Maryland1
  • Sarasijhaa K Desikan, MD · PRINCIPAL_INVESTIGATOR · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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Eligibility criteria

Inclusion

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

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
  • Change in Mini BESTest scoreBaseline to 12 weeks

    The Mini BESTest is a reliable and valid measure of balance and mobility that is sensitive to changes in individuals with balance dysfunction, and has age-related normative values. It will be the primary outcome measure to evaluate changes in balance and mobility following exercise intervention. The Mini BESTest includes fourteen items that evaluate the following: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.