RecruitingPhase 3NCT06032065

SMART Exercise for PAD

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


Sponsor

Northwestern University

Enrollment

210 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Home-Based Exercise, Nitrate-rich beetroot Juice, and others for people with aging, peripheral arterial disease, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSupervised Treadmill Exercise

This is a 12 week intervention where participants will walk for exercise 3 times a week on a treadmill at a center while being supervised by healthcare personnel.

BEHAVIORALHome-Based Exercise

This is a 12 week intervention where participants will walk at home for exercise with guidance from a study coach. They will have 4 in person visits in the first four weeks and then have weekly phone calls in the last 8 weeks of the intervention with their coach.

DIETARY_SUPPLEMENTNitrate-rich beetroot Juice

Participants will drink one shot of nitrate rich beet-root juice twice daily for 12 weeks.


Locations(3)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06032065


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