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Behavioral Intervention

Exercise and Beetroot Juice for Peripheral Artery Disease (RESIST Trial)

Phase 2

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

An ABI of more than 0.90 and less than 1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test

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

Must not have

Planned major surgery, coronary or leg revascularization during the next six months

Current foot ulcer on bottom of foot

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 12 week to 24-week follow-up

Summary

This trial is looking at how exercise can help patients with peripheral artery disease (PAD). They will see if a 12-week exercise program can increase nitrite levels in the blood after 12 weeks compared

Who is the study for?

This trial is for individuals with Peripheral Arterial Disease (PAD), specifically those who experience intermittent claudication, which is muscle pain during exercise due to poor blood flow. Participants should be able to perform treadmill exercises and have not been involved in regular exercise programs recently.

What is being tested?

The RESIST PAD study tests if a 12-week supervised treadmill exercise program can increase nitric oxide levels compared to a control group. It also examines if adding nitrate-rich beetroot juice enhances benefits for those who don't initially respond well to the exercise alone.

What are the potential side effects?

Potential side effects may include discomfort from treadmill exercises such as muscle strain or fatigue. Drinking beetroot juice might cause stomach upset, colored stools, or other mild digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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My ABI score drops significantly after a physical leg test.

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I have been diagnosed with PAD based on vascular tests or angiography.

Exclusion Criteria

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

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

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I have had an amputation above or below the knee.

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I am on hemodialysis for end-stage kidney disease.

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

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I have not had major surgery or significant heart issues in the last 3 months.

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I use a wheelchair or walker to move around.

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My vision problems make it hard for me to walk.

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I have unstable chest pain.

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I have severe leg pain and poor blood flow (ABI < 0.40).

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 12-weeks to 24-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 12-weeks to 24-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 12-weeks to 24-week follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Six-minute walk

Secondary study objectives

Brachial artery flow-mediated dilation (FMD)

Calf muscle perfusion

Delta nitrite

Other study objectives

4 hydroxynonenal (4HNE)

BH4/BH2

Capillary Density

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Supervised Treadmill ExerciseExperimental Treatment1 Intervention

This group will be participating in supervised treadmill exercise for 12 weeks. Participants will walk for exercise on a treadmill 3 times per week at a center while supervised by healthcare personnel.

Group II: Exercise Supplementation with Nitrate-Rich Beetroot JuiceExperimental Treatment1 Intervention

This group for "non-responders" will receive supervised exercise supplementation with nitrate-rich beetroot juice for an additional 12 weeks.

Group III: Exercise Supplementation with Placebo Beetroot JuicePlacebo Group1 Intervention

This group for "non-responders" will received supervised exercise supplementation with placebo beetroot juice for the additional 12 weeks.

Group IV: Attention Control GroupPlacebo Group1 Intervention

This group will attend weekly one-hour educational sessions either on Zoom or in-person for 12 weeks. These sessions are on topics of interest to the typical PAD patient and may be led by study staff, physicians, or other health care workers.

0 / 13Eligibility criteria met