ClinConnect ClinConnect Logo
Search / Trial NCT06033924

Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Sep 5, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Peripheral Artery Disease Physical Activity Quality Of Life

ClinConnect Summary

This clinical trial is studying how to help veterans with Peripheral Artery Disease (PAD) improve their walking and overall quality of life through a home-based walking program. The program includes setting goals for steps taken, receiving tips for healthy walking, and motivational messages. Participants will be randomly assigned to one of two ways to receive this program: either through a web-based platform or via telehealth calls. After 12 weeks, those in the web-based or telehealth groups may switch to a combination of both methods for another 12 weeks. The entire study lasts 36 weeks and includes various assessments of walking ability and quality of life at different points.

To be eligible for this study, participants should be men or women diagnosed with PAD who experience leg pain when walking, but are still able to walk at least one city block. They should also be relatively inactive, exercising less than 150 minutes per week. Participants will need access to a phone or the internet and must be able to understand and sign the consent form. Those who are wheelchair-bound, have certain serious health conditions, or are currently very active in an exercise program are not eligible. Throughout the study, participants will receive vouchers for their involvement and will keep a pedometer to track their steps.

Gender

ALL

Eligibility criteria

  • 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Aurora, Colorado, United States

Palo Alto, California, United States

Birmingham, Alabama, United States

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Elizabeth A Jackson, MD

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported