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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Supervised Treadmill Exercise
BehavioralThis 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
BehavioralThis 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 productParticipants randomized to this group will drink nitrate-rich beetroot juice while engaged in supervised exercise.
Placebo + supervised exercise therapy
Combination productParticipants randomized to this group will drink placebo while engaged in supervised exercise.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Supervised Treadmill ExerciseExperimental treatment 1 intervention
Group B: Attention Control GroupSham comparator 1 intervention
Group C: Exercise Supplementation with Nitrate-Rich Beetroot JuiceExperimental treatment 1 intervention
Group D: Exercise Supplementation with Placebo Beetroot JuicePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Delta nitrite
Change in plasma nitrite from the beginning to the end of a maximal exercise stress test
Time frame
Baseline to 12-week follow-up2
Six-minute walk
Change in six-minute walk distance
Time frame
From 12-weeks to 24-week follow-upSecondary outcomes
1
Calf muscle perfusion
Change in calf muscle perfusion, measured with arterial spin labeling MRI
Time frame
Baseline to 12-week follow-up2
Calf muscle perfusion
Change in calf muscle perfusion, measured with arterial spin labeling MRI
Time frame
From 12-weeks to 24-week follow-up3
Brachial artery flow-mediated dilation (FMD)
Change in brachial artery diameter in response to post-cuff occlusion hyperemia
Time frame
Baseline to 12-week follow-up4
Brachial artery flow-mediated dilation (FMD)
Change in brachial artery diameter in response to post-cuff occlusion hyperemia
Time frame
From 12 weeks to 24-week follow-upOther outcomes
1
Dihydrobiopterin (BH2)
Change in plasma levels of BH2
Time frame
From baseline to 12-week follow-up2
Dihydrobiopterin (BH2)
Change in plasma levels of BH2
Time frame
From 12 week to 24-week follow-up3
Tetrahydrobiopterin (BH4)
Change in plasma levels of BH4
Time frame
From baseline to 12-week follow-up4
Tetrahydrobiopterin (BH4)
Change in plasma levels of BH4
Time frame
From 12 week to 24-week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov