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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Improving Mobility After Revascularization in Peripheral Artery Disease
At a glance
Conditions
Where it's being run
7 sites across 6 statesWho to contact
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What this trial measures
- Six-Minute Walk Distance 6-month changeBaseline to 6-month follow-up
Distance walked in six minutes