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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00106327
Eligibility Criteria:
Inclusion Criteria:
* 150 peripheral arterial disease patients with and without IC
Exclusion Criteria:
* Below or above-knee amputation
* Wheelchair confinement
* Inability to walk on a treadmill or inability to perform progressive resistance training
* Inability to return to the medical center three times weekly for 6 months
* Walking impairment due to a cause other than PAD
* Class II New York Heart Association (NYHA) heart failure or angina (heart failure or angina occurring at rest or with minimal exertion)
* Planned lower extremity revascularization or any other major surgery within 12 months
* Any increase in anginal symptoms during the previous 6 months or angina at rest
* Subjects with silent coronary ischemia, defined as ST segment depression greater than or equal to 1 mm during baseline exercise treadmill test without associated chest discomfort, unless they have had a normal perfusion stress test during the previous 6 months
* Subjects with left-bundle branch block or significant ST-T wave changes on their baseline ECG who do not have a perfusion stress test demonstrating absence of reversible ischemia within the previous 6 months
* Lower extremity revascularization, major orthopedic surgery, or other major surgery during the previous 3 months
* Myocardial infarction or coronary artery bypass grafting during the previous 3 months
* Major medical illnesses that may interfere with subject's ability to complete the interventions and/or follow-up testing
* Current foot ulcer
* ABI greater than 0.95
* Life expectancy less than 12 months
* Does not speak English
* Patient is currently involved in another clinical trial
* Dementia
* Poorly controlled blood pressure
* Current significant exercise, defined as exercising three times weekly for 30 minutes with sufficient exertion to produce a sweat or other exercise that is comparable to the exercise interventions offered in our protocol
* Treatment for cancer (other than non-melanoma skin cancer) during the past 12 months (including radiation therapy, chemotherapy, or surgery)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00106327
Study Brief:
Protocol Section:
NCT00106327