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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and 24 weeks
Awards & highlights

SMART PAD 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.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.

SMART PAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PAD through tests or symptoms.
Select...
I am 50 years old or older.

SMART PAD Trial Timeline

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

SMART PAD 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

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,021 Total Patients Enrolled
3 Trials studying Aging
80 Patients Enrolled for Aging

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of this trial?

"This clinical trial requires 210 qualified participants. These patients can be sourced from the University of Chicago in Minneapolis, Minnesota and the University of Virginia in Charlottesville, Virginia."

Answered by AI

What detrimental effects can arise from executing a treadmill routine with nitrate rich beetroot juice?

"The safety of supervised treadmill exercise combined with nitrate rich beetroot juice was rated a 3 due to the multiple rounds of data that supports its efficacy and protective benefits."

Answered by AI

Are participants still being sought to join this medical experiment?

"The most recent information from clinicaltrials.gov indicates that the trial is actively seeking patients, having first been published on September 8th 2023 and being updated as recently as September 7th of that same year."

Answered by AI

Who else is applying?

What site did they apply to?
Northwestern University Feinberg School of Medicine
University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I need money for school.
PatientReceived 1 prior treatment
~140 spots leftby Nov 2028