Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Intervention
Other interventionThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Exercise InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to 12 weeksSecondary outcomes
1
Change in secondary mobility measures (Four square step test [FSST])
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.
Time frame
Baseline to 12 weeks2
Change in time to peak (TTP) delay on perfusion-weighted MRI
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.
Time frame
Baseline to 12 weeks3
Secondary measures of cerebral perfusion (breath-holding index [BHI])
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.
Time frame
Baseline to 12 weeks4
Change in secondary mobility measures (Walking while talking test [WWT])
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.
Time frame
Baseline to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov