Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

NCT05436600 | Recruiting DMC

• 2 other identifiers: E3798-W1IK2RX003798-01A2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Asymptomatic carotid stenosis

Outcome Measures

Primary Outcomes (1)

• Change in Mini BESTest score

  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.

  Baseline to 12 weeks

Secondary Outcomes (5)

• Change in secondary mobility measures (Four square step test [FSST])

  Baseline to 12 weeks

• Change in time to peak (TTP) delay on perfusion-weighted MRI

  Baseline to 12 weeks

• Secondary measures of cerebral perfusion (breath-holding index [BHI])

  Baseline to 12 weeks

• Change in secondary mobility measures (Walking while talking test [WWT])

  Baseline to 12 weeks

• Secondary measures of cerebral perfusion (functional near infrared spectroscopy [fNIRS])

  Baseline to 12 weeks

Study Arms (2)

Control

NO 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.

Exercise Intervention

EXPERIMENTAL

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.

Other: Exercise Intervention

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.

Also known as: AeroBal exercise intervention

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

RECRUITING

Study Officials

• Sarasijhaa K Desikan, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarasijhaa K Desikan, MD

CONTACT

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

Kimberlly A Nordstrom

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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 with weekly contact by the study team.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 29, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)