title: Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.
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.
authors.affiliation: School of Nursing, University of Minnesota, Minneapolis, MN 55455, USA. brona001@umn.edu
authors.forename: Ulf G
authors.initials: UG
authors.lastname: Bronas
authors.forename: Alan T
authors.initials: AT
authors.lastname: Hirsch
authors.forename: Timothy
authors.initials: T
authors.lastname: Murphy
authors.forename: Dalynn
authors.initials: D
authors.lastname: Badenhop
authors.forename: Tracie C
authors.initials: TC
authors.lastname: Collins
authors.forename: Jonathan K
authors.initials: JK
authors.lastname: Ehrman
authors.forename: Abby G
authors.initials: AG
authors.lastname: Ershow
authors.forename: Beth
authors.initials: B
authors.lastname: Lewis
authors.forename: Diane J
authors.initials: DJ
authors.lastname: Treat-Jacobson
authors.forename: M Eileen
authors.initials: ME
authors.lastname: Walsh
authors.forename: Niki
authors.initials: N
authors.lastname: Oldenburg
authors.forename: Judith G
authors.initials: JG
authors.lastname: Regensteiner
mesh_terms: D003362:Cost-Benefit Analysis; D005081:Exercise Therapy / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D007383:Intermittent Claudication / Q000191:economics / Q000209:etiology / Q000628:therapy*; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000191:economics / Q000628:therapy*; D012107:Research Design; D015607:Stents / Q000191:economics; D016896:Treatment Outcome; D014481:United States; D014656:Vascular Surgical Procedures / Q000191:economics / Q000295:instrumentation*