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Exercise Intervention for Carotid Stenosis and Mobility Impairment (ACCOF-Ex Trial)
N/A
Recruiting
Led By Sarasijhaa K Desikan, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible patients will be at least 18 years of age and will have asymptomatic 50-69% carotid stenosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
ACCOF-Ex Trial Summary
This trial is investigating whether a supervised program of aerobic and balance exercises can help improve the balance and mobility of people with moderate carotid artery stenosis, and whether these changes are linked with improvements in cerebral perfusion.
Who is the study for?
This trial is for adults over 18 with moderate (50-69%) asymptomatic carotid artery stenosis, confirmed by medical history and imaging tests. It's not for those with Parkinson's, severe depression, recent strokes or TIA, planned carotid surgery, exercise restrictions from doctors, or who already do regular structured aerobic exercise.Check my eligibility
What is being tested?
The study tests how a supervised program of aerobic and balance exercises affects balance and mobility in patients with moderate asymptomatic carotid stenosis. It also examines if these changes correlate with alterations in brain blood flow.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with physical activity such as muscle strains, falls during balance training or general fatigue. Specific side effects will depend on individual health conditions.
ACCOF-Ex Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with a partially blocked carotid artery but no symptoms.
ACCOF-Ex Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Mini BESTest score
Secondary outcome measures
Change in secondary mobility measures (Four square step test [FSST])
Gait, Unsteady
Change in time to peak (TTP) delay on perfusion-weighted MRI
+2 moreACCOF-Ex Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,234 Total Patients Enrolled
1 Trials studying Carotid Stenosis
170 Patients Enrolled for Carotid Stenosis
Sarasijhaa K Desikan, MDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience significant drops in blood pressure when standing up.I have a blocked or severely narrowed artery in my neck.I can stand on one leg for 10 seconds without losing balance.You exercise aerobically more than three times a week on a regular basis.The severity of narrowing in the blood vessels will be checked using ultrasound, magnetic resonance angiography, or CT angiography.I have a health issue that makes it hard for me to walk or exercise.I have had a stroke or a transient ischemic attack.I have a severe illness that could affect the study's results.I am scheduled for a procedure to improve blood flow in my neck arteries.I do not have a history of dementia or cognitive issues, and I can follow commands.I have no symptoms of carotid stenosis, confirmed by medical exams and the NIH Stroke Scale.I cannot have an MRI with contrast due to an allergy or kidney issues.I have not had eye surgery or untreated vision problems in the last 6 months.I have a neurological condition or major depression.I am 18 or older with a partially blocked carotid artery but no symptoms.Your doctor has told you not to exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Exercise Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project accept participants who are thirty years of age or older?
"This trial is enrolling patients who are between 18 and 89 years of age."
Answered by AI
Is enrollment still active for this medical research project?
"Per the information available on clinicaltrials.gov, this experiment is currently recruiting participants for enrollment. It was initially posted on October 1st 2022 and recently amended on November 23rd 2022."
Answered by AI
How many subjects is the team targeting to recruit for this experiment?
"Affirmative. The clinical trial, which was first listed on October 1st 2022 is currently in the process of recruiting patients. It needs to enlist 50 people from a single medical centre as per its latest update dated November 23rd 2022."
Answered by AI
Is it possible to sign up for the research project?
"The study has opened its recruitment to 50 participants with limited mobility within the age bracket of 18 and 89. To be considered, they must have a carotid stenosis measuring between 50-69%, as verified through duplex sonography, MR angiography or CT angiography. Additionally, their condition should also conform to the NIH trials requirements for an asymptomatic status confirmed by medical history assessment, physical examination and the National Institutes of Health Stroke Scale (NIHSS)."
Answered by AI
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