BACKGROUND: It is not clear whether subgroups of patients with peripheral artery disease (PAD) and claudication respond more favorably to exercise rehabilitation than others. We determined whether sex and diabetes were factors associated with the response to exercise rehabilitation in patients with claudication. METHODS: Eighty patients were randomized to home-based and supervised exercise programs, and 60 finished with complete exercise intervention data. Exercise consisted of intermittent walking to near maximal claudication pain for 3 months. Primary outcome measures included claudication onset time (COT) and peak walking time. Patients were partitioned into diabetic and nondiabetic groups and then further partitioned by sex to form four groups. RESULTS: Overall, exercise adherence was high (84%), and there was no significant difference (p > 0.05) in the amount of exercise completed among the four groups. All groups had significant improvements (p < 0.05) in COT and peak walking time after exercise rehabilitation, except for diabetic women (p > 0.05). Only 37% of women with diabetes had an increase in COT compared with 100% of men with diabetes (p < 0.01), and their risk ratio for nonresponse was 9.2 (p < 0.0001). CONCLUSIONS: Women with PAD and claudication, particularly those with diabetes, represent a vulnerable subgroup of patients who respond poorly to a program of exercise rehabilitation. Diabetic women with PAD and claudication may need a greater dose of exercise or another intervention separate from or in combination with exercise to elicit improvements in claudication measures that are similar to nondiabetic women and to diabetic and nondiabetic men.

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