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Exercise Therapy for PAD Using Mobile Health

Recruiting

Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring

Who can join

Ages 40 and older · All sexes

Full eligibility criteria
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

  * 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

About the study

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.

What is being tested

Sponsor: VA Office of Research and Development · Participants: 75 · Started: Dec 1, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04889105

Locations in the U.S.

GeorgiaAtlanta VA Medical and Rehab Center, Decatur, GA, Decatur

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.