Response to Exercise and Nitric Oxide in Peripheral Artery Disease: The RESIST PAD Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product, Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• An ABI less than or equal to 0.90 at baseline.

• 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.

• 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.

Locations
United States
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
University of Chicago
NOT_YET_RECRUITING
Chicago
Contact Information
Primary
Mary M McDermott, MD
mdm608@northwestern.edu
312-503-6419
Backup
Kathryn Domanchuk, BS
k-domanchuk@northwestern.edu
312-503-6438
Time Frame
Start Date: 2025-01-23
Estimated Completion Date: 2029-10-01
Participants
Target number of participants: 200
Treatments
Experimental: Supervised Treadmill Exercise
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.
Sham_comparator: Attention Control Group
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.
Experimental: Exercise Supplementation with Nitrate-Rich Beetroot Juice
This group for non-responders will receive supervised exercise supplementation with nitrate-rich beetroot juice for an additional 12 weeks.
Placebo_comparator: Exercise Supplementation with Placebo Beetroot Juice
This group for non-responders will received supervised exercise supplementation with placebo beetroot juice for the additional 12 weeks.
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Northwestern University

This content was sourced from clinicaltrials.gov