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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04889105
Eligibility Criteria:
Inclusion Criteria:
* Age \>40 years
* Eligible Veteran status
* Clinically stable intermittent claudication ( 2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
* Established PAD diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)
* Access to safe location to perform walking exercises
Exclusion Criteria:
* Above or below knee amputation
* critical limb ischemia (rest pain or tissue loss including ulceration or gangrene)
* inability to walk without a walker
* wheelchair confinement
* non-English speaking
* significant visual impairment that interferes with walking activity
* hearing impairment that interferes with full study participation
* unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention
* Individuals whose walking is limited by a condition other than PAD
* Any active cardiac condition including unstable angina
* unstable atrial or ventricular arrhythmias
* high-grade heart block without a pacemaker
* active myopericarditis
* recent venous thromboembolism
* or recent abnormal baseline stress test suggesting ischemia
* other high-risk findings (e.g., drop of systolic blood \> 20 mmHg with exercise)
* Presence of Class III NYHA heart failure or CCS III angina.
* Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months
* Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)
* neurodegenerative disorders such as Parkinson's Disease that impair walking ability
* cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)
* Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months
* Mental health illness that may interfere with the ability to consent and/or participate in the study, including mini-mental status examination score \<24
* dementia
* active psychiatric disorder such as schizophrenia or bipolar disorder
* history of suicidal or homicidal ideation in the preceding six months
* history of suicidal attempts in the preceding 12 months
* history of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)
* Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider
* Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
* Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)
* Deemed to be poorly suited for the study or the study intervention at the discretion of the PI or study staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04889105
Study Brief:
Protocol Section:
NCT04889105