Rehabilitation Service, Hospital Sírio-Libanês, São Paulo, Brazil.
Haemodialysis Centre, Hospital Sírio-Libanês, São Paulo, Brazil.
BMJ Open. 2022 Nov 9;12(11):e062062. doi: 10.1136/bmjopen-2022-062062.
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.
简介:神经肌肉电刺激(NMES)作为一种辅助策略,可增加慢性肾脏病(CKD)行血液透析(HD)患者的孤立肌肉力量或耐力,已广泛研究。然而,联合应用低频率和高频率以改善肌肉力量和耐力的效果尚不清楚。本试验旨在评估该联合 NMES 策略在该人群中的疗效。
方法和分析:这是一项随机对照试验,评估采用盲法。共招募 56 名 CKD 行 HD 的患者,并将其随机分配至 NMES 方案。在基线和 24 次随访后将进行 3 次不同的评估。评估将包括背景、胰岛素样生长因子、乳酸测量、营养不良和炎症评分评估、电生物阻抗检查、通过医学研究理事会量表进行的整体肌肉评估、握力评估、下肢肌肉等速评估、6 分钟台阶试验表现和生活质量(QoL)问卷(重点是身体功能)。患者将被分配到以下 4 个组中的 1 个:1)联合低和高频率;2)低频率;3)高频率;4)假刺激(仅产生感觉感知,无可见收缩的最小强度)。在所有组中,整个治疗期间的强度将是患者可耐受的最高强度(对照组除外)。主要终点是周围肌肉功能(肌肉力量和耐力)的变化。次要终点将是身体成分的变化;肌肉营养;运动耐量;QoL;以及营养、炎症和代谢标志物。这项研究的结果有望提供有关如何优化 NMES 干预的有价值的知识,从而改善肌肉力量和耐力。
伦理和传播:本方案已获得 Sirio-Libanes 医院人类研究伦理委员会的批准(批准号:24337707)。将从每位参与者处获得书面知情同意。研究结果将发表在同行评议的期刊上。
试验注册号:NCT03779126。
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