Proposed research protocol to study the effects of adding fitness devices to vascular rehabilitation for the treatment of claudication

Abstract

Peripheral vascular disease affects millions of adults in the United States annually. Between $224 and $414 billion dollars in health care spending goes towards medications, procedures, and hospitalizations for peripheral vascular disease every year. Claudication is the most common and often earliest symptom of peripheral vascular disease. Supervised exercise programs have been shown to be at least equally as effective as percutaneous interventions for claudication symptoms and thus could save millions of dollars, decrease interventions and hospitalizations, and thereby increase quality of life for claudicants when universally implemented as first-line therapy. However, there are many barriers to widespread use of supervised exercise therapy for patients with claudication. Recently portable fitness tracking devices have been developed, but they have not been utilized as a component of supervised exercise therapy. It was our hypothesis that we could utilize this technology to overcome some of the barriers to enrollment and participation in supervised exercise therapy as well as improve the durability of the results. We developed a research protocol to evaluate the use of walking tracking devices as part of a home program following completion of a supervised exercise program. The goal was to identify improvements in patients’ walking distances and quality of life following completion of a supervised exercise therapy program and to evaluate if these improvements were maintained by providing the patient a fitness device that would track their walking distances and allow them to upload that data to the research team. Unfortunately, recruitment and enrollment in the study was slow, and the study was closed. We wish to share the research protocol and what we have learned with other investigators who may desire to study supervised exercise therapy, walking distance, and quality of life with or without the inclusion of a portable fitness device on exercise treatment for claudication.