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Patient-centered home exercise program for peripheral artery disease
Investigator (PI): McDermott, Mary
Performing Organization (PO): (Current): Northwestern University, Feinberg School of Medicine, Department of Medicine, Division of General Internal Medicine and Geriatrics / (312) 926-8269
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/CER-1306-02719
Funding: Total Award Amount: $2,090,661
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Lower extremity peripheral artery disease (PAD) is a common and chronic condition that affects eight million people in the U.S. PAD patients have difficulty walking because cholesterol blockages in their leg arteries prevent adequate oxygen supply to leg muscles during walking activity. PAD patients reduce their physical activity levels and slow their walking speed to avoid leg pain during walking activity. The following quotes from PAD patients who helped us 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. Supervised 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 it is not paid for by medical insurance and the requirements are burdensome for PAD patients. We have engaged PAD patients and relevant stakeholders to develop a home-based exercise intervention that is tailored to the needs of patients with PAD. 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 nine-month follow-up, compared to usual care. The outcome measures of our trial were selected by PAD patients because they best represent PAD patients' physical limitations. All outcomes are well-validated and accepted outcome measures. Our 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 health care providers for PAD patients, has contributed to this proposal and will monitor all aspects of the study as it is conducted, providing 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.
MeSH Terms:
  • Exercise
  • Health Behavior
  • Health Promotion /methods
  • Humans
  • Life Style
  • Monitoring, Ambulatory /*methods
  • Outcome Assessment (Health Care)
  • Patient-Centered Care /*organization & administration
  • Peripheral Arterial Disease /*rehabilitation
  • Program Development
  • Program Evaluation
  • Randomized Controlled Trials as Topic
  • Telemedicine
  • United States
  • Walking
Country: United States
State: Illinois
Zip Code: 60611
UI: 20152156
CTgovId: NCT01408901
Project Status: Completed
Record History: ('2018: Project extended to 2019 ',) ('2017: Project extended to 2018',)