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Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by University of Michigan
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Elizabeth A. Jackson, University of Michigan Identifier:
First received: December 5, 2013
Last updated: February 7, 2017
Last verified: February 2017
With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality. While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals. Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, with an online community builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD). Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program with a social media component, to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD. Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group. The Internet-based walking program with a social media component has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes. There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients. High risk patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.

Condition Intervention
Peripheral Arterial Disease
Behavioral: Telephone counseling
Behavioral: Internet-based walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in maximal walking distance [ Time Frame: Baseline, 4 months, 12 months ]

Secondary Outcome Measures:
  • Change in pain-free walking distance [ Time Frame: Baseline, 4 months, 12 months ]
  • Change in health-related quality of life [ Time Frame: Baseline, 4 months, 12 months ]
  • Change in average weekly step counts [ Time Frame: Baseline, 4 months, 12 months ]
  • Change in number of days with regular walking [ Time Frame: Baseline, 4 months, 12 months ]
  • Frequency of uploading step counts [ Time Frame: 4 months ]
  • Frequency of interactions on the message boards [ Time Frame: 4 months ]
  • Cost of the Internet-based walking program compared to supervised PAD rehab [ Time Frame: 5 years ]
  • Change in healthcare utilization [ Time Frame: 4 months, 12 months ]
    Information about the use of health care services will include any inpatient utilization, outpatient use, and medications taken during the 12-month study period.

  • Frequency of uploading step counts [ Time Frame: 12 months ]
  • Frequency of interactions on the message boards [ Time Frame: 12 months ]

Estimated Enrollment: 200
Study Start Date: September 2014
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telephone Counseling
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
Behavioral: Telephone counseling
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Experimental: Internet-based walking program
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation. Subjects have access to group-specific forums in which they may communicate with other PAD patients in the study
Behavioral: Internet-based walking program
Four-month Internet-based walking program consisting of weekly step count goals, a personalized website with an online community, and tailored tips.
Experimental: Telephone counseling and Internet-based walking program
Combination of previous two arms
Behavioral: Internet-based walking program
Four-month Internet-based walking program consisting of weekly step count goals, a personalized website with an online community, and tailored tips.
No Intervention: Usual Care
Subjects will continue with their health care as usual and will receive access to the study website (for arm 2) at the end of their participation


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 40
  • Diagnosis of PAD

    • documented ankle brachial index (ABI) ≤ 0.9 in at least one leg
    • toe brachial index ≤ .70 for participants with an ABI > 1.3
    • documented arterial disease by MRI, CT or angiogram if ABI is .91 to 1.3
  • Ability to walk at least 150 feet without the assistance of a cane or walker.
  • Are sedentary (defined as < 150 minutes per week of physical activity).
  • Able to obtain medical clearance from a primary care provider, cardiologist, vascular specialist, endocrinologist, nurse practitioner, or physician assistant.
  • Competent to give informed consent.
  • Have regular access to a computer with an Internet connection that allows software downloading.
  • Be a regular email user (check email at least once a week).

Exclusion Criteria:

  • PAD due to non-atherosclerotic causes such as trauma, entrapment syndromes or congenital anomalies.
  • Was diagnosed with or incurred any of the following cardiovascular events in the past 3 months:

    • stroke/transient ischemic attack
    • myocardial infarction
    • unstable angina
    • percutaneous coronary intervention
    • coronary bypass graft surgery
    • severe valve disease untreated
    • complex arrhythmias untreated
    • New York Heart Association class III-IV heart failure
  • Currently undergoing a cardiovascular workup for chest pain or other cardiac concerns.
  • Is scheduled for revascularization of the lower extremity in the next 12 months.
  • Currently pregnant.
  • Non-English speaking.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02022423

Contact: Elizabeth A. Jackson, MD MPH FACC (734) 998-7411

United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
National Institute on Aging (NIA)
Principal Investigator: Elizabeth A. Jackson, MD MPH FACC University of Michigan
  More Information

Additional Information:
Responsible Party: Elizabeth A. Jackson, Associate Professor, University of Michigan Identifier: NCT02022423     History of Changes
Other Study ID Numbers: R01AG045136-01 ( US NIH Grant/Contract Award Number )
Study First Received: December 5, 2013
Last Updated: February 7, 2017

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 24, 2017