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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth A. Jackson, University of Michigan
ClinicalTrials.gov Identifier:
NCT02022423
First received: December 5, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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 supervised PAD rehabilitation, or an Internet-based walking program or a combination of supervised PAD rehabilitation and Internet-based walking program. 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: Supervised PAD rehab
Behavioral: Internet-based walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pain-free walking distance [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
  • Change in health-related quality of life [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
  • Change in average weekly step counts [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
  • Change in number of days with regular walking [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
  • Frequency of uploading step counts [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Frequency of interactions on the message boards [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Cost of the Internet-based walking program compared to supervised PAD rehab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in healthcare utilization [ Time Frame: 4 months, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Frequency of interactions on the message boards [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2014
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supervised PAD rehab Behavioral: Supervised PAD rehab
Participants will attend supervised PAD rehab 3 times per week for up to 60 minutes per session for 4 months.
Experimental: Internet-based walking program 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: Supervised PAD rehab and Internet-based walking program Behavioral: Supervised PAD rehab
Participants will attend supervised PAD rehab 3 times per week for up to 60 minutes per session for 4 months.
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02022423

Contacts
Contact: Elizabeth A. Jackson, MD MPH FACC (734) 998-7411 lisjacks@med.umich.edu
Contact: Michelle Draska, MS (734) 232-0484 mdraska@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Elizabeth A. Jackson, MD MPH FACC University of Michigan
  More Information

No publications provided

Responsible Party: Elizabeth A. Jackson, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02022423     History of Changes
Other Study ID Numbers: R01 AG045136 01
Study First Received: December 5, 2013
Last Updated: September 5, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014