Exercise and Beetroot Juice for Peripheral Arterial Disease (IMPACT PAD Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Northwestern University

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. We hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. We further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity. In a randomized clinical trial with a 2 x 2 factorial design, we will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).

Eligibility Criteria

This trial is for patients with Peripheral Artery Disease (PAD) who have undergone revascularization but still experience walking difficulties. Participants should be within three months post-successful revascularization and willing to follow a home-based exercise program or consume beetroot juice.

Inclusion Criteria

My surgery to improve blood flow was successful.

Exclusion Criteria

I do not have a severe illness like lung disease needing oxygen, Parkinson's, or a terminal illness with less than 6 months to live.

My vision problems make it hard for me to walk.

I cannot communicate in English.

I have had severe blockages in my leg arteries causing pain and sores.

I am currently taking medication for erectile dysfunction.

I have had a leg amputation, but not just a toe or part of my foot.

I use a wheelchair or walker to move around.

My walking is limited due to a condition that is not peripheral artery disease.

I have a current foot ulcer on the bottom of my foot.

I have unstable chest pain.

I am scheduled for major surgery within the next six months.

I have had gangrene in the past.

Treatment Details

The study tests if home-based exercises or nitrate-rich beetroot juice can improve walking performance after leg artery surgery, compared to usual care alone. It's a randomized trial where participants are assigned by chance to one of four groups: exercise, placebo juice, nitrate juice, or attention control.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Home based exercise + nitrate rich beetroot juiceExperimental Treatment2 Interventions

This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months.

Group II: Attention control + nitrate-rich beetroot juiceExperimental Treatment2 Interventions

This group will be participating in attention control and drinking nitrate rich beetroot juice for six months.

Group III: Home-based exercise + placeboPlacebo Group2 Interventions

This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months.

Group IV: Attention control + placeboPlacebo Group2 Interventions

This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months.