SMART Exercise for PAD
Eligible age
50+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Northwestern University
You may qualify if…
- ✓ First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:
- ✓ 1. An ABI \<= 0.90 at baseline.
- ✓ 2. Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
- ✓ 3. An ABI of \>0.90 and \<1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
You may not qualify if…
- ✕ 1. Above- or below-knee amputation
- ✕ 2. Limb-threatening ischemia defined as an ABI \<0.40 with symptoms of rest pain
- ✕ 3. Wheelchair confinement or requiring a walker to ambulate
- ✕ 4. Walking is limited by a condition other than PAD
- ✕ 5. Current foot ulcer on bottom of foot
- ✕ 6. Unwilling to drink beetroot juice
- ✕ 7. Unwilling to accept randomization into either group (home based exercise or supervised exercise)
- ✕ 8. Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking exercise activity during the trial.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06032065 · last updated 2026-04-15