Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Phase

N/A

Condition

Carotid Artery Disease

Treatment

Exercise Intervention

Clinical Study ID

NCT05436600

E3798-W

1IK2RX003798-01A2

Ages 18-89
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 carotidstenosis, by medical history, physical examination, and the National Institutes ofHealth Stroke Scale (NIHSS)
Stenosis severity will be determined by duplex sonography, MR angiography, or CTangiography

Exclusion

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 orrenal insufficiency will also be excluded
given the possibility that comorbid cognitive impairment may influence balance andmobility function, subjects with any documented medical history of dementia orcognitive impairment or those unable to follow commands will be excluded from thestudy
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 beprescreened for balance dysfunction using a 10-second Single Leg Stance Test
those that are able to complete the test without losing balance on either sidewill be excluded from the study
the investigators will exclude subjects that participate in structured aerobicexercise routinely greater than three times per week within a month of starting thestudy

Study Design

Exercise Intervention

October 01, 2022

February 29, 2028

Study Description

The investigators will conduct a prospective randomized controlled trial designed to evaluate the effects of a supervised aerobic and challenging balance exercise (AeroBal) program on balance and mobility function (primary outcome), and fall risk and physical function (secondary outcomes) in patients with moderate ACAS. The investigators hypothesize that aerobic and challenging balance exercises will lead to greater improvement in balance and mobility function, de-creased fall risk, and improved perceived physical function in patients with moderate ACAS compared to standard-of-care vascular risk-factor reduction alone. Patients will undergo 1:1 blocked randomization on sex into either the exercise training group plus standard-of-care or the control group undergoing standard-of-care vascular risk-factor modification alone. To account for attrition, the investigators aim to enroll a total of 50 patients and anticipate completing the study with 34 patients. Baseline demographic data, medical history, balance and mobility function, physical function, cerebral perfusion (PW-MRI and fNIRS) and vasoreactivity (TCD) will be collected on all patients. The exercise training group will perform 12 weeks of supervised aerobic and balance exercises. In order to maintain consistency in contact between the clinical research team and the control subjects versus the intervention group, 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. To assess the change in outcome measures, the investigators will repeat measurements in both groups at 6- and 12-weeks. PW-MRI will only be performed at the 12-week visit to minimize patient risk and contain costs. The primary outcome measure (change in Mini BESTest score) and secondary measures (fall rate and physical function) for Aim 1, and the primary outcome measure (TTP on PW-MRI) and secondary outcome measures (BHI on TCD and change in oxy-hemoglobin concentration on fNIRS) for Aim 2 will be analyzed.

Connect with a study center

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland 21201
United States
Active - Recruiting

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