University of Oklahoma
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).
Specific Aims. The investigator proposes to test our central hypothesis that the NICE intervention performed without inducing leg ischemia and its' damaging sequela will be a superior exercise paradigm to increase peak walking time and HRQoL more than the Standard ischemic and painful exercise paradigm via greater improvement in microvascular mechanisms. This clinically relevant hypothesis will be tested through the following aims: Aim 1 (Exercise Outcomes) To compare the changes in ambulation and HRQoL in PAD patients randomized to either the NICE slow walking program or to the Standard prog…
Inclusion Criteria: 1. history of claudication assessed by the Walking Impairment Questionnaire, 2. 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, 3. 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. 4. age \>= 40 years. Exclusion Criteria: 1. absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise, 2. inability to ob…
Non-Ischemic Exercise (NICE), pain-free exercise program will be compared to the Standard painful exercise program.
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