The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention 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 Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
Eligibility criteria
Qualifiers
history of claudication assessed by the Walking Impairment Questionnaire,
ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,
an ABI <= 0.90 at rest or > 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
age >= 40 years.
Disqualifiers
absence of PAD (ABI > 0.90 at rest and ankle systolic blood pressure < 20% decrease after exercise,
inability to obtain an ABI measure due to non-compressible vessels (ABI > 1.40),
asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
rest pain due to PAD (Fontaine stage III)
Trial design
Treatments tested in this trial
- Exercise
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oklahoma
Lead sponsor
Case Western Reserve University
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov