Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease

Inclusion Criteria: All participants will have PAD. PAD will be defined as follows: first, an ankle-brachialindex (ABI) < or = 0.90 at the baseline study visit is an inclusion criterion for PAD.Second, potential participants with an ABI >0.90 who have vascular laboratory evidence ofPAD. Vascular laboratory evidence consists of objective evidence of PAD, including toebrachial index (TBI) < or = 0.70, Duplex measure showing 70% stenosis or greater, or ABIvalues < 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasivevascular laboratory test will not be sufficient for enrollment. Third, potentialparticipants with an ABI >0.90 who have angiographic evidence of PAD consisting of astenosis of 70% or greater in a lower extremity artery.

Exclusion Criteria:

1. Above- or below-knee amputation.
2. Critical limb ischemia or ABI < 0.30 in the setting of ischemic symptoms at rest orphysical examination findings consistent with critical limb ischemia. Some potentialparticipants with symptoms or signs of critical limb ischemia may be excluded at theprincipal investigator's discretion if the ABI is 0.30 or higher.
3. Wheelchair-bound.
4. Current foot ulcer on bottom of foot.
5. Walking is primarily limited by a symptom other than PAD.
6. Failure to successfully complete the study run-in.
7. Major surgery, revascularization, or orthopedic surgery in the past 3 months orplanned in the next 12 months.
8. Major medical illness including Parkinson's Disease, lung disease requiring oxygen,cancer requiring treatment in the previous two years, or life-threatening illness witha life expectancy of less than six months. Participants who only use oxygen at nightwill be potentially eligible. [NOTE: potential participants treated for cancer in thepast two years may still qualify if they have had treatment for early stage cancer inthe past two years and the prognosis is excellent. Potential participants treated forbasal cell or squamous cell skin cancer will not be excluded.]
9. Already exercising at a level consistent with exercise intervention. Current or recentparticipation in exercise rehabilitation (within the past three months).
10. Recently diagnosed (within the past three months) with acute lower extremity deepvenous thrombosis, pulmonary embolism, or severe heart failure (i.e. New York HeartAssociation (NYHA) Class III or IV).
11. Mini-Mental Status Examination (MMSE) score <23 or dementia.
12. Participation in or completion of a clinical trial in the previous three months.
13. Non-English speaking.
14. Increase in angina in the past month, angina at rest, or abnormal baseline treadmillstress test. Potential participants may become eligible after an abnormal baselinetreadmill stress test if they have evidence of an absence of coronary ischemia basedon testing (such as a stress test with imaging or a coronary angiogram) from a testperformed with their own physician and if they do not have symptoms of unstableangina. The evidence of absent coronary ischemia, based on an imaging stress test orcoronary angiogram, must have been performed within the previous year.
15. Ongoing infection of the toes, foot, or lower extremity.
16. Potential participants who started on cilostazol within the last three months. Theymay be evaluated for eligibility once three months have passed since beginningcilostazol.
17. Significant peripheral edema, defined as 3+ or greater edema severity, as determinedby the principal investigator.
18. BMI >45 kg/M2
19. Significant visual impairment that interferes with walking.
20. In addition to the above criteria, investigator discretion will be used to determineif the trial is unsafe or not a good fit for the potential participant.