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A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment

Lookup NU author(s): Professor Gerard Stansby

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Abstract

© 2018 Society for Vascular SurgeryObjective: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone. Methods: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership.

Publication metadata

Author(s): Lawton R, Babber A, Braithwaite B, Burgess L, Burgess LJ, Chetter I, Coulston J, Epstein D, Fiorentino F, Gohel M, Heatley F, Hinchliffe R, Horgan S, Pal N, Shalhoub J, Simpson R, Stansby G, Davies AH

Publication type: Article

Publication status: Published

Journal: Journal of Vascular Surgery

Year: 2019

Volume: 69

Issue: 5

Pages: 1567-1573

Print publication date: 01/05/2019

Online publication date: 18/02/2019

Acceptance date: 04/10/2018

ISSN (print): 0741-5214

ISSN (electronic): 1097-6809

Publisher: Mosby Inc.

URL: https://doi.org/10.1016/j.jvs.2018.10.046

DOI: 10.1016/j.jvs.2018.10.046

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