NCT06033924 · VA Office of Research and Development
Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease
(TREK-PAD)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Inability to speak and read English
Where
- Birmingham, Alabama
- Palo Alto, California
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations