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.

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.

High-efficiency short daily haemodialysis--morbidity and mortality rate in a long-term study.

BACKGROUND: In conventional haemodialysis (CHD), the morbidity and mortality rate is unacceptably high; consequently, variations in the length and frequency of the haemodialysis sessions have been studied to reduce the complications of dialysis treatment. In this sense, high-efficiency short daily haemodialysis (SDHD) has been proposed as an alternative for patients on renal replacement therapy. In this study, we have related our experience with this dialysis modality. METHODS: Twenty-six patients (16 males, mean age 35.6 +/- 14.7 years) were treated by SDHD for 33.6 +/- 18.5 months (range 6-57 months). The mean time on CHD before the switch to SDHD was 25.5 +/- 31.9 months (range 1-159 months). In 23 (88.5%) patients, native arteriovenous fistulae were used for vascular access. SDHD was performed six times a week, 1.5-2 h per session, and high flux polysulfone dialysers (surface area: 1.8 m(2)) were employed. The blood flow and dialysate flow rate were 350 and 800 ml/min, respectively. RESULTS: In this trial, the patient survival was 100%. The vascular access survival after 12, 24, 36 and 48 months on SDHD was 100, 89, 89 and 80%, respectively. There were three failures of vascular access in 72.7 patient-years (0.04 failures/patient-year). In 15 patients on SDHD during 36 consecutive months, the vascular access survival after 12, 24, 36 and 48 months was 100, 93, 93 and 84%, respectively. Also, in this group of patients, there were 0.27 hospitalizations/patient-year and 1.24 days of hospitalizations/patient-year. CONCLUSIONS: We concluded that in a long-time study of patients on SDHD the morbidity and mortality rate is very low. Furthermore, we observed that failures of vascular access are not a significant problem. Consequently, we believe that SDHD is a powerful renal replacement therapy for treatment of patients on maintenance haemodialysis.