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Exercise Therapy for Peripheral Artery Disease Using Mobile Health

This study is testing a new way to help Veterans with Peripheral Artery Disease (PAD) improve their walking. PAD is a condition where narrowed arteries reduce blood flow to your limbs, often causing leg pain when walking. The study is comparing a program called Smart MOVE!, which uses mobile health technology and coaching, to general walking advice. Researchers want to see if Smart MOVE! can help people walk further in a 6-minute walk test after 90 days. You may be able to join if you are a Veteran over 40 with stable PAD symptoms and can walk safely. The study aims to enroll 75 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 75 participants to compare two behavioral interventions: Smart MOVE! and general walking advice.
What's involved
Participants will receive either the Smart MOVE! program or general walking advice, and will use a mobile health device. Your walking ability will be measured with a 6-minute walk test at 90 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, a 6-minute walk test, is measured at 90 days.

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NCT04889105

Exercise Therapy for PAD Using Mobile Health

Recruiting
NAAges 40+InterventionalTreatment
VA Office of Research and Development
~75 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Smart MOVE!General walking advicePerformance evaluation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-minute walk test
Measured over 90 days

Conditions

Peripheral Artery Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Arash Harzand, MD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA

Who to contact

Arash Harzand, MD
[email protected]
(404) 321-6111 · ext. 20-5523
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 6-minute walk test90 days

    The 6MWT is a well-validated measure of functional capacity and increasingly recognized as a meaningful outcome measure in PAD. Participants will be asked to walk back and forth along a 100-foot hallway for six minutes using standard methods and have their total distance recorded