Recruiting

Exercise Intervention

Sponsor:

VA Office of Research and Development

Code:

NCT05436600

Conditions

Asymptomatic Carotid Stenosis (50-69%)

Mobility Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise Intervention

Study Details

Brief 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.

Conditions

Asymptomatic Carotid Stenosis (50-69%)

Mobility Impairment

Study ID

NCT05436600

Start date

Oct 1, 2022

Status verified date

Mar, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

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.

experimental: Exercise Intervention

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.

Interventions

Exercise Intervention

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.

Primary outcome measure

  • Change in Mini BESTest score [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Sarasijhaa K Desikan, MD

(410) 605-7000sdesikan@som.umaryland.edu

Kimberlly A Nordstrom

(410) 706-3941knordstrom@som.umaryland.edu

Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Frederick M Ivey, PhD

410-605-7000Frederick.Ivey@va.gov

Natalie V Dugger, BS

(410) 605-7000Natalie.Dugger@va.gov

Principal Investigator:

Sarasijhaa K Desikan, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Asymptomatic carotid stenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-04.