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. Author manuscript; available in PMC: 2010 Aug 1.
Published in final edited form as: Vasc Med. 2009 Aug;14(3):193–201. doi: 10.1177/1358863X08101018

Table 1.

Reasons for exclusion among participants completing a baseline appointment in the study to improve leg circulation

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.