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Active, not recruitingNCT04889105Smart MOVEUpdated Oct 2, 2026

Exercise Therapy for PAD Using Mobile Health

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

Updated Oct 2, 2026Now Active, not recruitingPrimary completion moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Peripheral Artery Disease

Keywords

  • Mobile health
  • Telemedicine
  • Peripheral artery disease
03

In context

Peripheral Arterial Disease

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible Veteran status
  • Clinically stable intermittent claudication (2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
  • Established peripheral artery disease (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

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 peripheral artery disease (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 millimetres of mercury (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 principal investigator (PI) or study staff
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
63 participants (actual)

Study arms

  • Other
    Performance evaluation

    Preliminary performance evaluation to refine the Smart MOVE! intervention.

    Behavioral: Performance evaluation

  • Active comparator
    Smart MOVE!

    Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.

    Behavioral: Smart MOVE!

  • Placebo comparator
    Usual care

    Participants will receive general walking advice for 12 weeks.

    Behavioral: General walking advice

Interventions

  • BehavioralSmart 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

  • BehavioralGeneral 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.

  • BehavioralPerformance 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Atlanta VA Medical and Rehab Center, Decatur, GA
    Decatur, Georgia 30033-4004, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 2, 2026
Primary completion
Sep 30, 2026→Oct 30, 2026
Oct 2, 2026
Study completion
Sep 30, 2026→Oct 30, 2026
Oct 2, 2026
Enrollment
75 (estimated)→63 (actual)
Oct 2, 2026
Also revised
eligibility and primary outcomes
Show all 1 update
  1. Oct 2, 2026
    Recruiting→Active, not recruiting
    Primary completion Sep 30, 2026→Oct 30, 2026
    Study completion Sep 30, 2026→Oct 30, 2026
    Enrollment 75 (estimated)→63 (actual)
    Eligibility Criteria revised
    Primary outcomes Revised (2 changes)
    + 4 other changes: identifiers, verification date, contact details and site details

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 ↗

10

Registry details

Key details

Study ID
NCT04889105
Lead sponsor
VA Office of Research and Development
Collaborators
LifeQ
Responsible party
Sponsor
First posted
May 17, 2021
Start date
Dec 1, 2021
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Oct 2, 2026

Study contacts

Arash Harzand, MD
principal investigator · Atlanta VA Medical and Rehab Center, Decatur, GA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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