Ankle-Brachial Index Changes Post Exercise and Its Effects on Patient-Centered Outcomes and Gait (NCT07637396) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ankle-Brachial Index Changes Post Exercise and Its Effects on Patient-Centered Outcomes and Gait
United States85 participantsStarted 2026-06
Plain-language summary
The goal of this observational study or clinical trial is to investigate how exercise can affect different areas of a person's life, especially those people with vascular disease. This is important because exercise can be beneficial for people with vascular disease. The study could include any of the following: those aged 65 years of age and older, between the ages of 50-64 who smokes, has diabetes, high blood pressure, high cholesterol, or has a family member with vascular disease, between the ages of 18-49 with diabetes and one other factor listed above, or those with vascular disease. The main question\[s\] it aims to answer is if exercise testing can better predict vascular disease.
The following research questions will be addressed in this study:
1. Does baseline ABI influence the magnitude and recovery trajectory of ABI following an acute bout of exercise across a spectrum of vascular function?
2. What association does exercise-induced ABI changes have on patient-reported outcomes of quality of life and intermittent claudication?
3. Do functional outcomes of gait speed, time to claudication, gait variables related to rest breaks in 6MWT, and walking distance predict the magnitude of exercise-induced ABI reduction?
Participants will :
* complete various questionnaires and a routine screening for vascular disease \*walk for 6 minutes at your own pace
* additional vascular screening tests will be performed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* individuals over 65 years of age
* individuals aged 50-64 with a risk factor for atherosclerosis including diabetes mellitus, history of smoking, hyperlipidemia, hypertension, or family history of peripheral arterial disease (PAD)
* individuals aged 18-50 with diabetes mellitus and one additional risk factor for atherosclerosis as noted above, or
* individuals with known atherosclerotic disease in another vascular bed including the coronary, carotid, subclavian, renal, or mesenteric artery stenosis, and individuals with known PAD
Exclusion Criteria
* contraindications to brachial and/or ankle pressure measurement including history of deep vein thrombosis
* lymphedema of the arms or legs
* history of mastectomy or current leg ulceration preventing placement of a blood pressure cuff around the lower leg
* an inability to lie in a supine position for 15 min
* self-reported inability to walk for 6 minutes
* severe cardiac or pulmonary disease limiting exercise
* inability to obtain a Dopplerable pulse
* noncompressible arteries (ABI \>1.4)
* those unable to consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
magnitude of ABI reduction
Timeframe: immediately after exercise, at 1-, 3-, and 5-minute recovery intervals.
Trial details
NCT IDNCT07637396
SponsorLouisiana State University Health Sciences Center Shreveport