Improving Mobility After Revascularization in Peripheral Artery Disease

This study is for people with Peripheral Artery Disease (PAD), a condition where narrowed arteries reduce blood flow to the limbs, causing leg pain when walking (intermittent claudication). It's for those who have recently had a procedure to restore blood flow (revascularization) in their legs. The study aims to see if home-based exercise, guided by a coach, or drinking nitrate-rich beetroot juice can improve walking ability after revascularization. Participants will be randomly assigned to one of four groups: home-based exercise, nitrate-rich beetroot juice, an attention control group (weekly health topic discussions), or a placebo beetroot juice group. The main goal is to measure how much your walking distance improves over six months. You can join if you are 18 or older and had successful leg revascularization between 30 and 100 days before starting the study. You cannot join if you have had a leg amputation (other than a toe or partial foot), active gangrene, or active limb-threatening ischemia.

Study design
This interventional study plans to enroll 386 participants. It will compare different approaches to improve walking ability after revascularization for Peripheral Artery Disease.
What's involved
Participants in the home-based exercise group will walk at home and have weekly meetings or calls with a coach for six months. Those in the beetroot juice groups will drink juice twice daily for six months. The attention control group will have weekly meetings for 26 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Six-Minute Walk Distance, is measured at baseline and at the 6-month follow-up.

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NCT06686121

Improving Mobility After Revascularization in Peripheral Artery Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
Northwestern University
~386 participants
Updated 2025-08-26 on ClinicalTrials.gov
What's tested:Home Based ExerciseNitrate Rich Beetroot JuiceAttention ControlPlacebo Beetroot Juice Without Nitrate

At a glance

Recruiting sites
3 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Six-Minute Walk Distance 6-month change
Measured over Baseline to 6-month follow-up
Peripheral Artery Disease
Intermittent Claudication
Peripheral Vascular Disease
Mobility Limitation
Revascularization
7 sites across 6 states
Illinois2
Arizona1
California1
Georgia1
New Hampshire1
Pennsylvania1

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  • Six-Minute Walk Distance 6-month changeBaseline to 6-month follow-up

    Distance walked in six minutes