Lower extremity peripheral artery disease (PAD) is a common and chronic condition that affects 8 million people in the United States. PAD patients have difficulty walking because cholesterol blockages in their leg arteries prevent adequate oxygen supply to leg muscles during that activity. PAD patients reduce their physical activity levels and slow their walking speed to avoid leg pain.
The following quotes from PAD patients who helped the study team develop this proposal describe the impact of PAD on their daily lives: “I have found that [PAD] significantly limits my lifestyle.” “I’m embarrassed of all the time I spend watching TV.” “To a moderate extent, it is safe to say that I no longer look forward to the rest of my life.”
Few therapies are available to help PAD patients improve their walking limitations. Treadmill exercise programs that require three or more supervised exercise sessions per week at an exercise facility can help PAD patients walk with less pain. However, most people with PAD do not participate in supervised exercise programs because they are not paid for by medical insurance and the requirements are burdensome for the patients.
We have engaged PAD patients and relevant stakeholders to develop a home-based exercise intervention that is tailored to the needs of the patients. Our home-based exercise intervention includes a Fitbit activity monitor and a coach who will telephone PAD participants at regularly scheduled intervals. PAD patients will use the Fitbit to help them monitor their exercise behavior. The coach will use well-established behavioral methods during the scheduled telephone calls to help PAD patients adhere to regular walking exercise.
We will conduct a randomized controlled trial of 200 patients with PAD to determine whether our home-based walking exercise program significantly improves walking performance and other patient-centered outcomes at the nine-month follow-up, compared to usual care.
PAD patients selected the trial’s outcome measures as those that best represent PAD patients’ physical limitations. All outcomes are well-validated and accepted outcome measures. The primary outcome measure is the six-minute walk test, an objective measure of walking endurance. Secondary outcomes consist of the Walking Impairment Questionnaire and the PROMIS questionnaires that assess patient-perceived walking ability, mobility, pain, and social functioning.
Our investigative team includes two patients with PAD who contributed to all aspects of this proposal. In addition, our Advisory Committee, consisting of PAD patients and healthcare providers for PAD patients, has contributed to this proposal and will monitor all aspects of the study as it is conducted and provide regular feedback to investigators.
If our home-based exercise intervention is successful, the intervention will have a substantial impact on the large and growing number of people disabled by PAD.