Efficacy of neuromuscular electrical stimulation with combined low and high frequencies on body composition, peripheral muscle function and exercise tolerance in patients with chronic kidney disease undergoing haemodialysis: a protocol for a randomised, double-blind clinical trial.

Autor:	Moraes IG; Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil., Brito CP; Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil., Francisco DS; Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil., Faria LM; Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil., Luders C; Haemodialysis Centre, Hospital Sírio-Libanês, São Paulo, Brazil., de Brito CMM; Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil., Yamaguti WP; Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil wellington.psyamaguti@hsl.org.br.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Nov 09; Vol. 12 (11), pp. e062062. Date of Electronic Publication: 2022 Nov 09.
DOI:	10.1136/bmjopen-2022-062062
Abstrakt:	Introduction: Neuromuscular electrical stimulation (NMES) as an adjunctive strategy to increase isolated muscular strength or endurance has been widely investigated in patients with chronic kidney disease (CKD) undergoing haemodialysis (HD). However, the efficacy of combined low and high frequencies, to improve both muscular strength and endurance, is unknown. This trial aims to evaluate the efficacy of this combined NMES strategy in this population. Methods and Analysis: This is a randomised controlled trial with blinded assessments and analysis. A total of 56 patients with CKD undergoing HD will be recruited and randomised to an NMES protocol. The evaluations will be performed on three different days at baseline and after 24 sessions of follow-up. Assessments will include the background, insulin-like growth factor, lactate measurement, malnutrition and inflammation score evaluation, an electrical bioimpedance examination, global muscular evaluation by means of the Medical Research Council scale, handgrip strength evaluation, muscular isokinetic evaluation of lower limbs, 6 min step test performance and quality of life (QoL) questionnaire with emphasis on physical function. The patients will be allocated in one of the following four groups: 1) combined low and high frequencies; 2) low frequency; 3) high frequency; and 4) sham stimulation with minimal intensity to generate only sensory perception (with no visible contraction). In all groups, the intensity throughout the session will be the highest tolerated by patient (except for control group). The primary endpoint is the change of peripheral muscle function (muscular strength and endurance). The secondary endpoints will be the changes of body composition; muscle trophism; exercise tolerance; QoL; and nutritional, inflammatory, and metabolic markers. The findings of this study are expected to provide valuable knowledge on how to optimise the NMES intervention, with improvements in both muscle strength and endurance. Ethics and Dissemination: This protocol has been approved by the Ethics Committee on Research with Humans of Hospital Sírio-Libanês (approval no. 24337707). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals. Trial Registration Number: NCT03779126. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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