The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Oklahoma
About this trial
This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.
Eligibility criteria
Qualifiers
History of claudication,
Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest < 0.90, or > 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (> 0.90), or history of peripheral revascularization.
Disqualifiers
absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest > 0.90), < 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
non-compressible vessels (ABI > 1.40),
rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
Trial design
Treatments tested in this trial
- DASH Diet plus Home-Based Exercise
- Home-Based Exercise
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oklahoma
Lead sponsor
Milton S. Hershey Medical Center
Collaborator
National Institute on Aging (NIA)
Collaborator
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov