Home › Peripheral Arterial Disease › NCT04889105
Exercise Therapy for PAD Using Mobile Health
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
- Smart MOVE! (behavioral)
- General walking advice (behavioral)
- Performance evaluation (behavioral)
Sponsor: VA Office of Research and Development · Participants: 75 · Started: Dec 1, 2021
Contact the study team
- Arash Harzand, MD · Phone: (404) 321-6111
Official record on ClinicalTrials.gov — NCT04889105
Locations in the U.S.
| Georgia | Atlanta 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.