Response to Exercise and Nitric Oxide in PAD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorNorthwestern University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Above- or below-knee amputation
Limb-threatening ischemia defined as an ABI less than 0.40 with symptoms of rest pain
Wheelchair confinement or requiring a walker to ambulate
Walking is limited by a condition other than PAD
Trial design
Treatments tested in this trial
- Supervised Treadmill Exercise
- Attention Control
- Nitrate-Rich Beetroot Juice + supervised exercise therapy
- Placebo + supervised exercise therapy
Treatment groups
200 Participants
are divided into 4 treatment groupsSponsors and collaborators
Northwestern University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov