Response to Exercise and Nitric Oxide in PAD

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06657976
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Supervised Treadmill Exercise — BEHAVIORAL
    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.
  • Attention Control — BEHAVIORAL
    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.
  • Nitrate-Rich Beetroot Juice + supervised exercise therapy — COMBINATION_PRODUCT
    Participants randomized to this group will drink nitrate-rich beetroot juice while engaged in supervised exercise.
  • Placebo + supervised exercise therapy — COMBINATION_PRODUCT
    Participants randomized to this group will drink placebo while engaged in supervised exercise.

Study Details

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.

Key Dates

Start date
Jan 23, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Delta nitrite [ Time Frame: Baseline to 12-week follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Kathryn Domanchuk
[email protected]
312-503-6438
Mary M McDermott, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Tamar Polonsky, MD
[email protected]
773-702-6153
Tamar Polonsky, MD (PRINCIPAL_INVESTIGATOR)

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By condition
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By specialty
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By research site
Northwestern University Feinberg School of Medicine· Chicago, ILUniversity of Chicago· Chicago, IL

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