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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

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Title: 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
Authors: 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, A
Item Type: Journal Article
Abstract: Objective: To assess the clinical efficacy of an NMES device to improve the absolute walking distance (AWD) in patients with IC, as an adjunct to the local standard care available at the study sites compared to local standard care alone. Methods: An open, multicentre, randomised controlled trial including eight participating centres in England. Sites are equally distributed between those that provide SET programmes and those that do not. Patients with IC meeting the inclusion and exclusion criteria, and providing consent will be randomised, depending on the centre type, to either NMES and locally available standard care or standard care alone. The primary endpoint, AWD, will be measured at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life assessment, compliance with the interventions, economic evaluation of the NMES device, and lower limb haemodynamic measures to further the understanding of underlying mechanisms. Recruitment is due to commence in February 2018 and will continue for a total of 15 months. The NESIC trial is funded by the UK Efficacy and Mechanism Evaluation (EME) Programme, Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. ISRCTN 18242823.
Issue Date: May-2019
Date of Acceptance: 4-Oct-2018
URI: http://hdl.handle.net/10044/1/64994
DOI: https://dx.doi.org/10.1016/j.jvs.2018.10.046
ISSN: 0741-5214
Publisher: Elsevier
Start Page: 1567
End Page: 1573
Journal / Book Title: Journal of Vascular Surgery
Volume: 69
Issue: 5
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: NIHR / MRC EME Project Grant 15/180/68
Keywords: Science & Technology
Life Sciences & Biomedicine
Surgery
Peripheral Vascular Disease
Cardiovascular System & Cardiology
Randomized controlled trial
Supervised exercise therapy
Neuromuscular electrical stimulation
Intermittent claudication
Absolute walking distance
SUPERVISED EXERCISE PROGRAMS
PERIPHERAL ARTERY-DISEASE
ADJUVANT BENEFIT
ANGIOPLASTY
MANAGEMENT
FEMOROPOPLITEAL
PREVALENCE
THERAPY
ADVICE
TRIAL
Absolute walking distance
Intermittent claudication
Neuromuscular electrical stimulation
Randomized controlled trial
Supervised exercise therapy
11 Medical and Health Sciences
Cardiovascular System & Hematology
Publication Status: Published
Online Publication Date: 2019-02-18
Appears in Collections:Department of Surgery and Cancer



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