Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
VA Office of Research and Development
Study ID
NCT05436600
Status
Recruiting
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Conditions

  • Asymptomatic Carotid Stenosis (50-69%)
  • Mobility Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Exercise Intervention — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimoreMaryland21201
Frederick M Ivey, PhD
[email protected]
410-605-7000
Natalie V Dugger, BS
[email protected]
(410) 605-7000
Sarasijhaa K Desikan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD· Baltimore, MD

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