Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention (ACCOF-Ex)

March 2, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Principal Investigator:
          • Sarasijhaa K Desikan, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Other Names:
  • AeroBal exercise intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mini BESTest score
Time Frame: Baseline to 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in secondary mobility measures (Four square step test [FSST])
Time Frame: Baseline to 12 weeks
The FSST assesses dynamic mobility by timing patients while they quickly step over an object (i.e., canes) while moving forward, laterally, and backward. The score is based on time take to complete the task (seconds). The FSST was chosen because it has excellent reliability, normative values, and scores are predictive of falls in older adults.
Baseline to 12 weeks
Change in time to peak (TTP) delay on perfusion-weighted MRI
Time Frame: Baseline to 12 weeks
TTP is a perfusion-weighted magnetic resonance imaging (PW-MRI) measure that quantifies the delay in time taken for contrast to reach maximum concentration. The difference between the TTP measurements of the ipsilateral and contralateral hemispheres will be calculated to arrive at the TTP delay. TTP delay has low inter-observer and inter-scan variability, and is sensitive to early perfusion impairment.
Baseline to 12 weeks
Secondary measures of cerebral perfusion (breath-holding index [BHI])
Time Frame: Baseline to 12 weeks
Transcranial Doppler is non-invasive, readily available, does not utilize contrast, and allows for quantification of cerebral vasoreactivity via a breath-holding index (BHI). A BHI of <0.69 indicates impaired cerebrovascular hemodynamics.
Baseline to 12 weeks
Change in secondary mobility measures (Walking while talking test [WWT])
Time Frame: Baseline to 12 weeks
The WWT Test is a dual-task interference test that measures divided attention to assess cognitive-motor interactions. Participants will be asked to walk while reciting the alphabet aloud (WWT-simple) and while reciting alternate letters of the alphabet aloud (WWT-complex). The score is based on time taken to complete the task. The WWT Test is responsive to change after exercise intervention in older adults, associated with perceived physical function, and predictive of falls.
Baseline to 12 weeks
Secondary measures of cerebral perfusion (functional near infrared spectroscopy [fNIRS])
Time Frame: Baseline to 12 weeks
fNIRS is a novel imaging technology that measures cerebral hemodynamic responses by using the absorption of near-infrared light to identify changes in oxy- and deoxy- hemoglobin concentrations evoked by neural activity, otherwise known as neurovascular coupling. Change in oxyhemoglobin concentrations measured during tasks at baseline and 12 weeks will be compared.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarasijhaa K Desikan, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E3798-W
  • 1IK2RX003798-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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