Background. Exercise rehabilitation is advocated to improve function in patients with peripheral arterial disease (PAD) who have intermittent claudication. Patients with PAD often have comorbid medical problems that may interfere with their ability to safely participate in exercise rehabilitation programs. There is a paucity of information regarding the medical comorbidities and the evaluation of PAD patients before their participation in exercise rehabilitation studies. The purpose of this study was to identify comorbidities that predicted exclusion of PAD patients from participation in an aerobic exercise rehabilitation clinical trial. Methods. This was a prospective cohort study of 225 consecutive outpatient volunteers (mean age 68 ± 8 years, SD) with a history of Fontaine Stage II PAD recruited for exercise rehabilitation. Patient eligibility was determined by a history and physical exam, blood chemistries, measurement of ankle to brachial index (ABI), and an exercise treadmill test. Results. Seventy-nine volunteers (35%) were medically ineligible: 22 because of symptomatic coronary artery disease, 12 because of severe PAD, and the rest for a variety of medical problems. In stepwise logistic regression analyses, low ABI and use of insulin were predictors of exclusion, whereas peripheral revascularization was an indicator of inclusion. Age, a history of coronary artery disease, myocardial infarction, coronary bypass surgery, and hypertension were not independent determinants of eligibility. Conclusions. Insulin-requiring diabetes and a low ABI increase the likelihood that older patients with PAD will be ineligible to participate in a research exercise rehabilitation program, whereas peripheral revascularization was associated with inclusion. Whether intensive medical management and peripheral revascularization would enable the claudicants deemed ineligible for entry into the exercise rehabilitation program to safely exercise remains to be determined.
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