An interventional study of Smart MOVE! and General walking advice in Peripheral Artery Disease, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
An estimated 8.5 million Americans (or 7% of US adults) and nearly 10% of veterans are estimated to have peripheral arterial disease (PAD). Significantly debilitating and negatively impacting quality of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors.
Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population's travel to group facilities in the current COVID pandemic.
A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. The goal is of this study is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD.
This technology-enhanced approach for HBET will be conducted by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. This newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device to improve convenience, access, and adherence to HBET for PAD.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 63 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
Above or below knee amputation
Any active cardiac condition including unstable angina
Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)
Mental health illness that may interfere with the ability to consent and/or participate in the study, including mini-mental status examination score \<24
Preliminary performance evaluation to refine the Smart MOVE! intervention.
Behavioral: Performance evaluation
Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.
Behavioral: Smart MOVE!
Participants will receive general walking advice for 12 weeks.
Behavioral: General walking advice
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
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.
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
6-minute walk test (6MWT)
The 6MWT is a well-validated measure of functional capacity and increasingly recognized as a meaningful outcome measure in peripheral artery disease (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
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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