Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for Peripheral Artery Disease: The SMART PAD Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

⁃ First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:

• An ABI \<= 0.90 at baseline.

• 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.

• 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.

Locations
United States
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Mary McDermott, MD
mdm608@northwestern.edu
312-503-6438
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 210
Treatments
Experimental: Supervised treadmill exercise + nitrate rich beetroot juice
This group will be participating in Supervised Treadmill Exercise and drinking nitrate rich beetroot juice for 12 weeks.
Placebo_comparator: Supervised treadmill exercise + placebo
This group will be participating in Supervised Treadmill Exercise and drinking placebo beetroot juice with nitrate removed for 12 weeks.
Experimental: Home-based walking exercise + nitrate rich beetroot juice
This group will be participating in Home-Based Exercise and drinking nitrate rich beetroot juice for 12 weeks.
Placebo_comparator: Home-based walking exercise + placebo
This group will be participating in Home-Based Exercise and drinking placebo beetroot juice with nitrated removed for 12 weeks.
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov