NCT04889105 · VA Office of Research and Development
Exercise Therapy for PAD Using Mobile Health
(Smart MOVE)
What this study is about
Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation.
View original scientific description
Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.
Interventions
BEHAVIORAL
Smart MOVE!
Multi-component behavioral intervention of PAD consisting of: 1. guideline-directed HBET prescription 2. active behavioral coaching (via MOVE! program or other) 3. mobile health monitoring
BEHAVIORAL
General walking advice
Basic guidance on performing walking exercises for PAD according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching.
BEHAVIORAL
Performance evaluation
Preliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include: 1. Provider and stakeholder interviews 2. PAD patient interviews 2\) N-of-1 trials to refine the intervention
Primary outcome measures
6-minute walk test
Time frame: 90 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
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
- 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 criteria
- 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
- 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
Where
- Decatur, Georgia
Collaborators
LifeQ
Related conditions & keywords
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 Apr 21, 2026 · Source of record for eligibility and locations