Home-based exercise therapy for Veterans with Peripheral Artery Disease
Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring
This study tests a home-based exercise program using mobile technology to see if it can help Veterans with Peripheral Artery Disease walk better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT04889105 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of a home-based exercise therapy program delivered through mobile health technologies for Veterans suffering from symptomatic Peripheral Artery Disease (PAD). The program, called Smart MOVE!, combines group behavioral coaching with a wearable activity monitor to facilitate exercise in a convenient setting. Given the challenges Veterans face in accessing traditional supervised exercise therapy, this innovative approach aims to improve mobility and quality of life for those affected by PAD. The study will assess the effectiveness of this program in enhancing walking ability and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans over 40 years old with clinically stable intermittent claudication and a confirmed diagnosis of PAD.
Not a fit: Patients who have experienced amputations or have critical limb ischemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve walking ability and quality of life for Veterans with PAD.
How similar studies have performed: Other studies have shown promise in using home-based exercise programs for similar conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Decatur, Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Arash Harzand, MD — Atlanta VA Medical and Rehab Center, Decatur, GA
- Study coordinator: Arash Harzand, MD
- Email: Arash.Harzand@va.gov
- Phone: (404) 321-6111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.