Expired Study
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Oklahoma City, Oklahoma 73117


Purpose:

The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.


Study summary:

Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function. This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.


Criteria:

Inclusion Criteria: - lower extremity arterial bypass at least 3 months prior to screening - infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening Exclusion Criteria: - persistent rest pain due to (peripheral artery disease (PAD) (Fontaine Stage III for PAD), - persistent tissue loss due to PAOD (Fontaine Stage IV for PAD), - medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.) - cognitive dysfunction (mini-mental state examination score of less than 24)


NCT ID:

NCT00667290


Primary Contact:

Principal Investigator
Andrew W. Gardner, PhD
University of Oklahoma


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73117
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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