Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention (ACCOF-Ex)
Asymptomatic Carotid Stenosis (50-69%), Mobility Impairment
About this trial
This is an interventional treatment trial for Asymptomatic Carotid Stenosis (50-69%) focused on measuring Asymptomatic carotid stenosis
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
Sites / Locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Exercise Intervention
The control group will undergo standard-of-care vascular risk factor modification. Control participants will be contacted via telephone on a weekly basis to discuss the importance of vascular risk factor management and adherence to prescribed medical management.
The exercise intervention group will undergo 12 weeks of AeroBal exercise training (approximately 3 times/week). Each exercise session will consist of a 5-minute warm-up walk, approximately 30 minutes of aerobic exercise at a goal of 60-75% HRmax, 15 minutes of balance exercises, and a 5-minute cool-down walk.