Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT01332058
Eligibility Criteria:
Inclusion Criteria:
* African American (determined by self-report)
* Lived most of their life in the United States
* Resting ABI \<0.95
* English Speaking
* Has a telephone
Exclusion Criteria:
* Currently walking for exercise at least 5 days per week (i.e., a PACE score ranging from 5-8)
* Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
* Rest pain with ABI \<0.4 and non-palpable femoral pulses without prior evaluation by a vascular surgeon, given the need for evaluation for the role of more invasive therapy prior to recommending walking therapy
* Leg revascularization within 3 months of enrollment or plans for revascularization during the study period
* Use of supplemental oxygen
* Myocardial infarction within the preceding 3 months
* Resting blood pressure \> 200/110 mmHg
* Exercise-induced coronary ischemic symptoms, or exercise-induced ST depression \> 2.0 mm
* Inability to walk for 2 minutes; the rationale being that people who cannot walk for 2 minutes would not be able to complete the necessary submaximal treadmill test, which is used to screen for coronary ischemic symptoms. We will also exclude anyone who can walk for 20 minutes or more during the submaximal treadmill test. Anyone who can complete the submaximal test would not have significant walking impairment and would not get that much out of the study.
* Short Physical Performance Battery score of 10 or higher as such persons do not have a clinically significant impairment in mobility; therefore, we will exclude anyone who scores a 10 or higher (out of a maximum of 12 points).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01332058
Study Brief:
Protocol Section:
NCT01332058