Exercise Therapy for PAD Using Mobile Health

Recruiting now · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT04889105

Run by

VA Office of Research and Development

People needed

75

Starts

2021-12-01

Expected to finish

2026-09-30

Last updated by the study team

2026-04-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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