Improving Walking and Mobility After Lower Extremity Revascularization in Peripheral Artery Disease Using Home Exercise and Beetroot Juice A Phase 3 Randomized Clinical Trial

What this Trial Is About

Researchers are investigating ways to improve walking ability in people with peripheral artery disease PAD who have undergone lower extremity revascularization for disabling symptoms. The study evaluates whether adding home-based exercise or drinking nitrate-rich beetroot juice can help improve walking distance more than revascularization alone. This randomized clinical trial has a two-by-two design and aims to test these interventions in 386 patients within three months after successful revascularization. Participants will be assigned to one of four groups home-based exercise plus nitrate-rich beetroot juice, home-based exercise plus placebo beetroot juice, attention control plus nitrate-rich beetroot juice, or attention control plus placebo beetroot juice. The home-based exercise involves walking at home with coaching support over six months, starting with 2-4 weekly meetings followed by weekly phone calls. Beetroot juice or placebo shots are taken twice daily for six months. The attention control group attends weekly educational sessions on health topics during the same period. During the study, patients will undergo baseline and follow-up assessments including a six-minute walk test to measure walking distance. Additional questionnaires will evaluate walking impairment and mobility. Researchers will monitor blood flow in the treated vessels and measure nitric oxide levels in the blood. The main outcomes are measured at six and twelve months after starting the interventions. Safety, adherence, and quality of life will be tracked throughout the study, which plans to follow participants up to eight years after enrollment.

Improving Mobility After Revascularization in Peripheral Artery Disease