Home-based walking program for veterans with peripheral artery disease
Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease (TREK-PAD)
NA · VA Office of Research and Development · NCT06033924
This study is testing two ways to deliver a home walking program for veterans with peripheral artery disease to see if it helps them walk farther and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT06033924 on ClinicalTrials.gov |
What this trial studies
This study evaluates two methods of delivering a home-based walking program for veterans with peripheral artery disease (PAD). Participants will be randomized to receive either a web-based or telehealth-delivered walking program, or usual care. The program includes step count goals, healthy walking information, and motivational messages, and lasts for a total of 36 weeks. The study aims to assess improvements in walking distance and quality of life among participants. Additionally, those who do not respond to their initial program may be re-randomized to a combination of both delivery methods.
Who should consider this trial
Good fit: Ideal candidates are veterans diagnosed with lower extremity PAD who are able to walk at least one city block and have a sedentary lifestyle.
Not a fit: Patients with severe comorbidities that limit walking or those who are wheelchair-bound will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve walking ability and quality of life for veterans with peripheral artery disease.
How similar studies have performed: Other studies have shown success with similar home-based walking interventions, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 2 other locations
- 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)
Study contacts
- Principal investigator: Elizabeth A Jackson, MD — Birmingham VA Medical Center, Birmingham, AL
- Study coordinator: Elizabeth A Jackson, MD
- Email: elizabeth.jackson2@va.gov
- Phone: (205) 933-8101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Artery Disease, peripheral artery disease, physical activity, quality of life