NCT06657976 · Northwestern University
Response to Exercise and Nitric Oxide in PAD
(RESIST)
What this study is about
RESIST PAD is a randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Supervised Treadmill Exercise
This is a 12 week intervention where participants will walk for exercise 3 times a week on a treadmill at a center while being supervised by healthcare personnel.
BEHAVIORAL
Attention Control
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.
COMBINATION_PRODUCT
Nitrate-Rich Beetroot Juice + supervised exercise therapy
Participants randomized to this group will drink nitrate-rich beetroot juice while engaged in supervised exercise.
COMBINATION_PRODUCT
Placebo + supervised exercise therapy
Participants randomized to this group will drink placebo while engaged in supervised exercise.
Primary outcome measures
Delta nitrite
Time frame: Baseline to 12-week follow-up
Change in plasma nitrite from the beginning to the end of a maximal exercise stress test
Six-minute walk
Time frame: From 12-weeks to 24-week follow-up
Change in six-minute walk distance
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- An ABI less than or equal to 0.90 at baseline. 2. 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. 3. 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.
Exclusion criteria
- Above- or below-knee amputation 2. Limb-threatening ischemia defined as an ABI less than 0.40 with symptoms of rest pain 3. Wheelchair confinement or requiring a walker to ambulate 4. Walking is limited by a condition other than PAD 5. Current foot ulcer on bottom of foot 6. Failure to complete study-run 7. Unwilling to accept randomization into either group (supervised exercise or attention control) 8. Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking ex
Where
- Chicago, Illinois
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations