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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
Pivotal Trial
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.
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.
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 belowSelect...
I have been diagnosed with PAD through tests or symptoms.
Select...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have unstable chest pain.
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I have had an amputation above or below the knee.
Select...
I have severe leg pain at rest due to poor blood flow.
Select...
I use a wheelchair or walker to move around.
Select...
My walking is limited due to a condition that is not peripheral artery disease.
Select...
I have a current ulcer on the bottom of my foot.
Select...
I have advanced kidney disease and need dialysis.
Select...
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.
Select...
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.
Select...
I am not willing to stop consuming beetroot products during the study.
Select...
I do not speak English.
Select...
My vision problems make it hard for me to walk.
Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
20-meter Improvement in Six-Minute Walk Distance
PROMIS Mobility Questionnaire Score
Six-Minute Walk Distance
+2 moreOther study objectives
Physical Activity Step Count
Physical Activity Total Distance
Physical activity distance
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~180
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,305 Total Patients Enrolled