Status:
RECRUITING
Exercise Therapy for PAD Using Mobile Health
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
LifeQ
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04889105
Start Date
December 1 2021
End Date
September 30 2026
Last Update
September 26 2025
Active Locations (1)
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1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004