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



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:11/30/2018
Start Date:September 2014
End Date:June 2019
Contact:Hillary Y Gahagan, MPH
Email:hillarygahagan@uabmc.edu
Phone:(205) 975-9319

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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. Patients such as those with PAD
(a CAD risk equivalent) stand to benefit the most from such programs.


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.
We found this trial at
2
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Elizabeth A Jackson, MD MPH
Phone: 205-975-9319
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-232-0484
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