Patient Centered Home Exercise Program for Peripheral Artery Disease

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

The purpose of this study is to determine the effects of a home-based exercise intervention on walking ability in people with peripheral artery disease. In 200 patients with peripheral artery disease (PAD), the investigators are conducting a randomized controlled trial to determine whether a patient-centered home-based exercise program improves walking ability, physical activity, mobility, pain, and social functioning, compared to a usual care group.

Key facts

Study ID

NCT02462824

Run by

Northwestern University

People needed

200

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2018-01-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with an ankle brachial index (ABI) ≤ 0.90 will be eligible for participation.
• Participants with an ABI > 0.90 but ≤ 1.00 who experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible.
• Participants with an ABI > 0.90 who have medical record evidence of prior lower extremity revascularization for PAD will be eligible
• Participants with an ABI > 0.90 who have medical record evidence of PAD based on non-invasive vascular laboratory testing or based on angiographic findings will be eligible. Non-invasive vascular laboratory evidence of PAD must be obtained from a vascular laboratory.

You may not qualify if…

• Above or below knee amputation, critical limb ischemia, wheelchair confinement, foot ulcer, non-English speaking, significant visual impairment that interferes with walking activity, hearing impairment that interferes with full study participation, unable to return to the medical center or fitness center at the expected visit frequency, or unwilling to use technology required for the intervention.
• Individuals whose walking is limited by a condition other than PAD.
• Greater than class II NYHA heart failure or angina. Increase in angina, angina at rest, abnormal baseline stress test.
• Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next nine months.
• Major medical illness including lung disease requiring oxygen, Parkinson's disease that impairs walking ability, or cancer requiring treatment in the prior two years (potential participants may still qualify if they were diagnosed with non-melanoma skin cancer in the past two years or if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent).
• Heart attack, stroke, or coronary artery bypass surgery in the last 3 months.
• Mini-mental status examination score < 23, dementia, or psychiatric illness.
• Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• Currently enrolled in another clinical trial, exercise trial, or in cardiac rehabilitation. Currently enrolled in a clinical trial or current participation in cardiac rehabilitation or a trial of a therapeutic intervention within the past three months. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as s at least six months has passed since the participant received their final treatment in the stem cell or gene therapy study .
• Deemed a poor candidate for the study or poorly suited for the intervention (at PI discretion).

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Northwestern University feinberg School of Medicine — Chicago, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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