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Behavioral Intervention

SMART Exercise for Peripheral Arterial Disease (SMART PAD Trial)

Phase 3

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will have PAD defined as either: An ABI <= 0.90 at baseline, Vascular lab evidence of PAD, or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities, or 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

Participants will be age 50 and older

Must not have

Unstable angina

Above- or below-knee amputation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and 24 weeks

Awards & highlights

Summary

This trial will address two barriers to exercise therapy in people with PAD to improve walking distance, reduce disability, and increase exercise tolerance. Participants will do either supervised treadmill exercise or home-based walking exercise with or without nitrate-rich beetroot juice.

Who is the study for?

This trial is for individuals over 50 with Peripheral Arterial Disease (PAD), evidenced by specific tests. They must not have severe limb ischemia, amputations, or be wheelchair-bound. Participants should not already be highly active or have major health issues like end-stage kidney disease, recent surgeries, certain cancers, unstable angina, or dementia.Check my eligibility

What is being tested?

The study compares four approaches to improve walking in PAD: supervised treadmill exercise with beetroot juice; the same exercise with a placebo; home-based walking with beetroot juice; and home-based walking with a placebo. The goal is to find out which combination is most effective for reducing PAD-related disability.See study design

What are the potential side effects?

Potential side effects may include reactions to beetroot juice such as stomach upset or allergic reactions. Exercise might cause muscle soreness or exacerbate symptoms of PAD temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PAD through tests or symptoms.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unstable chest pain.

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I have had an amputation above or below the knee.

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I have severe leg pain at rest due to poor blood flow.

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I use a wheelchair or walker to move around.

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My walking is limited due to a condition that is not peripheral artery disease.

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I have a current ulcer on the bottom of my foot.

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I have advanced kidney disease and need dialysis.

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I am not planning any major surgery or heart/leg artery procedures in the next 6 months.

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I haven't had major surgery or significant heart issues in the last 3 months.

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I do not have a major illness like lung disease needing oxygen, Parkinson's, a life-threatening condition expected to end my life within six months, or cancer treated in the last two years.

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I am not willing to stop consuming beetroot products during the study.

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I do not speak English.

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My vision problems make it hard for me to walk.

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I use a strong germ-killing mouthwash and don't want to stop.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

20-meter Improvement in Six-Minute Walk Distance

PROMIS Mobility Questionnaire Score

Six-Minute Walk Distance

+2 more

Other outcome measures

Physical Activity Step Count

Physical Activity Total Distance

Physical activity distance

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Supervised treadmill exercise + nitrate rich beetroot juiceExperimental Treatment2 Interventions

This group will be participating in Supervised Treadmill Exercise and drinking nitrate rich beetroot juice for 12 weeks.

Group II: Home-based walking exercise + nitrate rich beetroot juiceExperimental Treatment2 Interventions

This group will be participating in Home-Based Exercise and drinking nitrate rich beetroot juice for 12 weeks.

Group III: Home-based walking exercise + placeboPlacebo Group1 Intervention

This group will be participating in Home-Based Exercise and drinking placebo beetroot juice with nitrated removed for 12 weeks.

Group IV: Supervised treadmill exercise + placeboPlacebo Group1 Intervention

This group will be participating in Supervised Treadmill Exercise and drinking placebo beetroot juice with nitrate removed for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home-Based Exercise

2010

Completed Phase 2

~110

0 / 16Eligibility criteria met

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,608 Previous Clinical Trials

927,107 Total Patients Enrolled

5 Trials studying Aging

146 Patients Enrolled for Aging

~140 spots leftby Nov 2028

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