EICHORCondition: Peripheral Artery Disease · Sponsor: VA Office of Research and Development
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Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality of life). This study will look at two types of delivery methods for a home-based walking program. The walking program includes step count goals, information on healthy walking and motivational messages. The two delivery methods include a web-based delivery and an telehealth delivery. Participants are randomized to either one of the delivery methods or usual care. After 12 weeks participants in the web based or telehealth based groups maybe re-randomized to receive a combination of both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is followed for an additional 12 weeks, so the total time a participant is in the study is 36 weeks. At baseline, 12, 24 and 36 weeks the investigators ask participant to walk (slowly) on a treadmill, perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are provided at each study visit. All participants who complete the study also keep their pedometer.
This description comes directly from the study's public registry record.
Elizabeth A Jackson, MD · (205) 933-8101 · elizabeth.jackson2@va.gov
Megan A Baker, BS · (205) 240-6552 · megan.baker6@va.gov
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Men and women * Diagnosis of lower extremity PAD due to atherosclerosis * Claudication with walking defined as stage 1-3 on the Rutherford Scale * Medical clearance from the patient's primary care provider or vascular care provider * Ability to walk at least one city block * Self-reported sedentary behaviors defined as \< 150 minutes per week of physical activity * Access to a phone and/or email \& Internet * Competent to provide informed consent Exclusion Criteria: * Life expectancy of less than six months * Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound) * Resident of a nursing home * Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise * Planned revascularization or amputation in the next two months * Recent CVD events (\< 3 months) including stroke/TIA, MI, UA, PCI/CABG * Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias) * Current substance abuse * Psychiatric disorder which limits the patient's ability to follow the study protocol * Pregnancy * Inability to speak and read English
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Birmingham VA Medical Center, Birmingham, AL | Birmingham, Alabama, United States | Not Yet Recruiting |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto, California, United States | Recruiting |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora, Colorado, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06033924