Actively Recruiting
Response to Exercise and Nitric Oxide in Peripheral Artery Disease: The RESIST PAD Trial
Led by Northwestern University · Updated on 2025-07-11
200
Participants Needed
2
Research Sites
13 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
This research aims to understand the biological effects of exercise in people with peripheral artery disease (PAD) and why some patients do not improve after exercise. The trial will study whether a 12-week exercise program increases the level of nitrite, a marker related to nitric oxide, and whether those who respond to exercise show greater nitrite increases compared to those who do not. For patients who do not respond, the study will test if adding nitrate-rich beetroot juice for another 12 weeks improves nitrite levels and walking ability. Participants will be randomly assigned to one of four groups. One group will do supervised treadmill exercise three times a week for 12 weeks. Another group will attend weekly one-hour educational sessions for 12 weeks, either online or in person. After 12 weeks, non-responders to exercise will be further randomized to receive either nitrate-rich beetroot juice or a placebo daily while continuing supervised exercise for an additional 12 weeks. This design allows comparison of exercise alone, education, and exercise with or without beetroot juice supplementation. During the study, participants will be monitored at baseline, 12 weeks, and 24 weeks. Assessments include measuring nitrite levels, walking ability with a six-minute walk test, calf muscle blood flow, and artery function through flow-mediated dilation. The trial will also track participants' adherence to exercise and supplement intake. Safety and response will be followed throughout the study period, which lasts about six months for each participant.
CONDITIONS
Brief Title
Response to Exercise and Nitric Oxide in PAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ankle-brachial index (ABI) of 0.90 or less at the start of the study
- Evidence of peripheral artery disease by vascular lab tests or at least 70% artery narrowing shown by angiography
- ABI between 0.90 and 1.00 with a 20% or greater drop after a heel-rise test
- Age 50 years or older
- Able to participate in supervised treadmill exercise
- Willing to accept randomization to exercise or education groups
You will not qualify if you...
- Above- or below-knee amputation
- Limb-threatening ischemia with ABI less than 0.40 and rest pain
- Wheelchair confinement or requiring a walker to walk
- Walking limitation due to conditions other than PAD
- Current foot ulcer on the bottom of the foot
- Failure to complete study-run
- Unwillingness to accept randomization
- Planning or engaging in new walking exercise outside the study during the trial
- Already exercising at a level similar to the study exercise
- End-stage kidney disease treated with hemodialysis
- Planned major surgery or vascular procedures in the next six months
- Recent major surgery or cardiovascular event within past three months
- Major illnesses such as lung disease requiring oxygen, Parkinson's, life-threatening illness with less than six months expectancy, or recent cancer treatment
- Mini-Mental Status Examination (MMSE) score below 23 or dementia
- Allergy to beetroot juice
- Current consumption of beetroot juice, oral nitrate or nitrite, or beetroot supplements without willingness to stop
- Consuming one cup or more of beets daily without willingness to stop
- Unstable angina
- Abnormal baseline stress test without clearance for exercise
- Non-English speaking
- Participation in another clinical trial within past three months
- Visual impairment limiting walking
- Baseline blood pressure below 100/45
- Participation in supervised treadmill exercise program recently or planning to start one soon
- Investigator discretion based on safety or trial fit considerations
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants engage in supervised treadmill exercise or attend weekly educational sessions for 12 weeks.
3 visits per week for supervised treadmill exercise or weekly 1-hour educational sessions for 12 weeks
Duration - 12 weeks
Non-responders participate in an additional 12 weeks of supervised exercise supplemented with either nitrate-rich beetroot juice or placebo beetroot juice.
3 visits per week for supervised exercise with supplement intake
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
K
Kathryn Domanchuk, BS
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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