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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02246660
Eligibility Criteria:
Inclusion Criteria:
* Ankle-brachial index (ABI) \< 0.90 at baseline screening (at visit), or, medical evidence of prior lower extremity revascularization if ABI ≥ 0.90.
* 65 or older
Exclusion Criteria:
* Above/below-knee amputation, critical limb ischemia, wheelchair-bound, or require the use of a walker or cane
* Other symptom(s) limiting walking ability, other than PAD
* Underwent/experienced lower extremity revascularization, a cardiovascular event, or coronary artery bypass surgery within 3 months of screening. Underwent major orthopedic surgery within 6 months of screening. Planning to have revascularization or major elective surgery within the next 6 months.
* Major medical illness including renal disease that requires dialysis or lung disease that requires oxygen
* Score of \< 23 on Mini-Mental Status Examination at screening or major psychiatric illness
* Currently participating in a separate clinical trial
* Significant renal or liver dysfunction at baseline
* Does not successfully complete the study run-in period
* Has an extreme baseline 6 minute walk value (\< 500 ft or \> 1,600 feet )
* Treated for cancer during the last 2 years (unless prognosis is excellent)
* Severe hearing impairment or other communication difficulties (e.g. non-English speaking) or legally blind
* Diagnosis of Parkinson's disease
* Unable to return to medical center at required visit frequency
* Otherwise poorly suited to intervention (at the discretion of the PI)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02246660
Study Brief:
Protocol Section:
NCT02246660