The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

Eligibility 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 \>= 60 years.
• 1. absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise,
• 2. inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40),
• 3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
• 4. rest pain due to PAD (Fontaine stage III)
• 5. tissue loss due to PAD (Fontaine stage IV)
• 6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
• 7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,
• 8. exercise tolerance limited by any disease process other than PAD,
• 9. active cancer,
• 10. kidney failure defined as stage 5 chronic kidney disease,
• 11. a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
• 12. pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
• 13. failure to complete the baseline run-in phase within three weeks.