Document Detail


Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.
MedLine Citation:
PMID:  19808716     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Ulf G Bronas; Alan T Hirsch; Timothy Murphy; Dalynn Badenhop; Tracie C Collins; Jonathan K Ehrman; Abby G Ershow; Beth Lewis; Diane J Treat-Jacobson; M Eileen Walsh; Niki Oldenburg; Judith G Regensteiner;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Vascular medicine (London, England)     Volume:  14     ISSN:  1358-863X     ISO Abbreviation:  Vasc Med     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-10-07     Completed Date:  2009-12-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9610930     Medline TA:  Vasc Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  313-21     Citation Subset:  IM    
Affiliation:
School of Nursing, University of Minnesota, Minneapolis, MN 55455, USA. brona001@umn.edu
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MeSH Terms
Descriptor/Qualifier:
Cost-Benefit Analysis
Exercise Therapy* / economics
Health Care Costs
Humans
Intermittent Claudication / economics,  etiology,  therapy*
Peripheral Vascular Diseases / complications,  economics,  therapy*
Research Design
Stents* / economics
Treatment Outcome
United States
Vascular Surgical Procedures / economics,  instrumentation*
Grant Support
ID/Acronym/Agency:
U01 HL07722/HL/NHLBI NIH HHS

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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