RECRUITING

Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Asymptomatic Carotid Stenosis and Mobility Function With Exercise Intervention

Quick Facts

Study Start:2022-10-01
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05436600

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eligible patients will be at least 18 years of age and will have asymptomatic 50-69% carotid stenosis
  2. * 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)
  3. * Stenosis severity will be determined by duplex sonography, MR angiography, or CT angiography
  1. * previous stroke or transient ischemic attack
  2. * occlusion or severe stenosis of the non-index carotid artery
  3. * planned carotid revascularization
  4. * persons advised by their doctor not to exercise
  5. * a medical condition that precludes the ability to ambulate
  6. * exercise or reduces the likelihood of follow-up
  7. * 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
  8. * orthostatic hypotension
  9. * severe medical illness that interferes with the evaluation of outcomes
  10. * uncorrected visual impairment or eye surgery in the past 6 months
  11. * patients that are unable to undergo PW-MRI due to gadolinium contrast allergy or renal insufficiency will also be excluded
  12. * 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
  13. * 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
  14. * 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
  15. * those that are able to complete the test without losing balance on either side will be excluded from the study
  16. * 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

Contacts and Locations

Study Contact

Sarasijhaa K Desikan, MD
CONTACT
(410) 605-7000
sdesikan@som.umaryland.edu
Kimberlly A Nordstrom
CONTACT
(410) 706-3941
knordstrom@som.umaryland.edu

Principal Investigator

Sarasijhaa K Desikan, MD
PRINCIPAL_INVESTIGATOR
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Locations (Sites)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Sarasijhaa K Desikan, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-10-01
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • Asymptomatic carotid stenosis

Additional Relevant MeSH Terms

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