Table 1.
Category of exclusion criterion | Exclusion criteria |
---|---|
Criteria selected because they may interfere with the participant's ability to participate fully in the study interventions (n = 107) | Dementia (n = 6) |
Above- or below-knee amputation (n = 1) | |
Critical limb ischemia or foot ulcers (n = 6) | |
Nursing home residence or extreme frailty (n = 8) | |
Inability to walk on a treadmill (n = 5) | |
Inability to speak English (n = 1) | |
Unable/unwilling to come to the medical center three times weekly (n = 57) | |
Failure to complete six run-in exercise sessions in 3 weeks (n = 23) | |
Criteria selected because they may influence study outcomes independently of study participation (n =14) | Major surgery or a myocardial infarction during the previous 3 months (n = 2) |
Major surgery planned during the next year (n = 12) | |
Current participation in other clinical trials (n = 0) | |
Criterion selected because it limited a potential participant's ability to respond to the intervention (n = 14) | Participant is already exercising at a level comparable to that offered by either exercise arm of the trial (n = 14) |
Criteria selected because they indicate that study participation may be unsafe (n = 38) | Unstable angina (n = 6) |
Abnormal baseline stress test (n = 32) | |
Miscellaneous exclusion criterion (n = 156) | Walking limited by a condition other than leg ischemia (n = 24); baseline SPPB = 12 (n = 123); poorly controlled blood pressure (n = 9) |
SPPB, short physical performance battery.