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Design of the multicenter standardized supervised exercise training intervention for the ‘CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study’

School of Nursing, University of Minnesotabrona001{at}umn.edu

Alan T Hirsch

Division of Epidemiology and Community Health, School of Public Health, University of Minnesota; Minneapolis Heart Institute Foundation

Timothy Murphy

Vascular Disease Research Center, Rhode Island Hospital; Department of Diagnostic Imaging, Brown Medical School

Dalynn Badenhop

Division of Cardiovascular Medicine, University of Toledo Medical Center

Tracie C Collins

Department of Medicine, Division of General Internal Medicine, University of Minnesota

Jonathan K Ehrman

Division of Cardiology, Henry Ford Hospital

Abby G Ershow

National Heart, Lung, and Blood Institute, National Institutes of Health

Beth Lewis

Department of Kinesiology, University of Minnesota

Diane J Treat-Jacobson

School of Nursing, University of Minnesota

M Eileen Walsh

Jobst Vascular Center

Niki Oldenburg

Division of Epidemiology and Community Health, School of Public Health, University of Minnesota

Judith G Regensteiner

Department of Medicine, Divisions of General Internal Medicine and Cardiology, Center for Women’s Health Research, University of Colorado Denver School of Medicine for the CLEVER Research Group

Abstract

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Key Words: clinical trials • exercise • intermittent claudication • peripheral arterial disease

Vascular Medicine, Vol. 14, No. 4, 313-321 (2009)
DOI: 10.1177/1358863X09102295


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