Actively Recruiting
Response to Exercise and Nitric Oxide in PAD
Led by Northwestern University · Updated on 2025-07-11
200
Participants Needed
2
Research Sites
244 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
RESIST PAD is a randomized trial of 200 PAD patients to establish: 1) whether a 12-week exercise intervention significantly increases Δ nitrite at 12-week follow-up, compared to control; 2) whether exercise "responders" have greater Δ nitrite increases compared to "non-responders"; 3) among non-responders, whether supplementing exercise with nitrate-rich beetroot juice between weeks 13-24 increases Δ nitrite and improves 6-minute walk at 24-week follow-up.
CONDITIONS
Official Title
Response to Exercise and Nitric Oxide in PAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Ankle-Brachial Index (ABI) less than or equal to 0.90 at baseline
- Vascular lab evidence of PAD (such as toe brachial pressure less than or equal to 0.70 or ABI less than or equal to 0.90), or angiographic evidence showing at least 70% artery narrowing in legs
- ABI between more than 0.90 and less than 1.00 with a 20% or greater drop in ABI in either leg after heel-rise test
You will not qualify if you...
- Above- or below-knee amputation
- Limb-threatening ischemia with ABI less than 0.40 and rest pain symptoms
- Wheelchair confinement or requiring a walker to walk
- Walking limited by conditions other than PAD
- Current foot ulcer on bottom of foot
- Unable to complete study-run
- Unwilling to accept randomization to exercise or control group
- Planning or unwilling to avoid new walking exercises during trial
- Already exercising at a level similar to study intervention
- End-stage kidney disease treated with hemodialysis
- Planned major surgery or revascularization within six months
- Major surgery, revascularization, or cardiovascular event in past three months
- Serious medical illnesses such as lung disease requiring oxygen, Parkinson's, life-threatening illness with less than six months life expectancy, or cancer needing treatment in past two years (some exceptions apply)
- Mini-Mental Status Examination score less than 23 or dementia preventing full participation
- Allergy to beetroot juice
- Currently consuming beetroot juice, oral nitrate/nitrite, or beetroot supplements and unwilling to stop for 30 days before and during study
- Consuming one cup or more of beets daily and unwilling to stop for 30 days before and during study
- Unstable angina
- Abnormal baseline stress test without physician clearance
- Non-English speaking (due to intervention delivery and communication needs)
- Participation in a clinical trial in past three months with specific timing rules depending on trial type
- Visual impairment limiting walking ability
- Baseline blood pressure less than 100/45
- Participation in supervised treadmill exercise program in past three months or planning to start in next six months
- Investigator discretion for safety or fit for trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
Research Team
M
Mary M McDermott, MD
CONTACT
K
Kathryn Domanchuk, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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