SMART Exercise for PAD (NCT06032065)
🩺 Plain-English Summary (8th-Grade Level)
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. Walking exercise is first line therapy to improve walking distance for PAD, but it does not eliminate ischemic leg symptoms in most people with PAD. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. Participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (28 items).
Location: Northwestern University Feinberg School of Medicine — Chicago, Illinois
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Above- or below-knee amputation
- Limb-threatening ischemia defined as an ABI \<0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a condition other than PAD
- Current foot ulcer on bottom of foot
- Unwilling to drink beetroot juice
- Unwilling to accept randomization into either group (home based exercise or supervised exercise)
- Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking exercise activity during the trial.
- Already exercising at a level consistent with exercise intervention.
- End-stage kidney disease (ESKD) associated with the need for dialysis.
- Planned major surgery, coronary or leg revascularization during the next six months
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois
- University of Chicago — Chicago, Illinois
- University of Minnesota — Minneapolis, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.