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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.
Full 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 of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors.
Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population's travel to group facilities in the current COVID pandemic.
A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. The goal is of this study is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD.
This technology-enhanced approach for HBET will be conducted by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. This newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device to improve convenience, access, and adherence to HBET for PAD.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Above or below knee amputation
Individuals whose walking is limited by a condition other than PAD
Any active cardiac condition including unstable angina
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)
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
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
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75 participants in 3 patient groups, including a placebo group
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Central trial contact
Arash Harzand, MD
Data sourced from clinicaltrials.gov
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