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

Abstract

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.

Supervised Exercise, Stent Revascularization, or Medical Therapy for Claudication Due to Aortoiliac Peripheral Artery Disease

“…It consisted of treadmill walking for up to 78 scheduled exercise sessions that were 1 h long, 3 days a week, for 6 months, as previously described (21). Patients in the SE group received quarterly contact by research coordinators during the supervised phase, and then participated in a telephone-based maintenance program designed to promote exercise adherence during the unsupervised phase of the study.…”

Exercise Standards for Testing and Training

“…Exercise training with treadmill walking has been used most frequently in clinical trials. [578][579][580][581][582] The treadmill walking exercise prescription for patients with PAD and symptoms of intermittent claudication consists of intermittent bouts of walking exercise at a work rate that brings on claudication until the patient has an ischemic leg pain score of mild-moderate (3-4 on a 5-point scale), followed by rest until pain completely subsides, and then resumption of exercise at a similar intensity. The rest and exercise bouts are repeated for a total of 50 minutes per day, including rest periods.…”

Peripheral Artery Disease: Current Insight Into the Disease and Its Diagnosis and Management

“…The treatment arms are: optimal medical care (claudication pharmacotherapy) 2 ; optimal medical care and supervised exercise 3 ; and optimal medical care and stent. [107][108][109] It is hoped that the CLEVER study will definitively establish the most appropriate and effective therapy for patients with aortoiliac disease.…”