NCT06032065

SMART Exercise for PAD

Recruiting now Phase 3 Last updated 15 April 2026

What this trial tests

Phase 3 trial testing Supervised Treadmill Exercise in Peripheral Arterial Disease in 210 participants. Currently enrolling.

Timeline

8 September 2023

Primary endpoint
1 November 2028

31 March 2029

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	210
Start date	8 September 2023
Primary completion	1 November 2028
Estimated completion	31 March 2029
Sites	3 locations across United States

Drugs / interventions tested

• Supervised Treadmill Exercise
• Home-Based Exercise
• Nitrate-rich beetroot Juice

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Aging — all drugs for Aging →
• Peripheral Vascular Diseases — all drugs for Peripheral Vascular Diseases →
• Walking, Difficulty — all drugs for Walking, Difficulty →

Sponsor

Northwestern University

Who can join

50 and older, any sex, with Peripheral Arterial Disease or Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials.
   McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, et al · · 2026 · PMID 42035974 · DOI 10.1016/j.ahj.2026.107450