Exercise program for improving mobility in patients with asymptomatic carotid stenosis
Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention
This study is testing whether a special exercise program can help people with asymptomatic carotid stenosis improve their balance and mobility, and reduce their risk of falling compared to just standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05436600 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a supervised aerobic and challenging balance exercise program on balance and mobility function in patients with moderate asymptomatic carotid stenosis. The study aims to determine if these exercises can reduce fall risk and improve physical function compared to standard care alone. Participants will be randomly assigned to either the exercise group or a control group receiving standard vascular risk-factor modification. The trial will collect various data, including demographic information, medical history, and measures of cerebral perfusion, to assess the outcomes of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with 50-69% asymptomatic carotid stenosis confirmed by medical evaluation.
Not a fit: Patients with a history of stroke, severe stenosis, or medical conditions that prevent exercise will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve balance and mobility, reducing the risk of falls and enhancing independence for patients with asymptomatic carotid stenosis.
How similar studies have performed: Similar studies have shown promise in using exercise interventions to improve mobility and reduce fall risk in older adults, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sarasijhaa K Desikan, MD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Sarasijhaa K Desikan, MD
- Email: sdesikan@som.umaryland.edu
- Phone: (410) 605-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.