Safety and Feasibility of Intradialytic Exercise Including Upper Limb Neuromuscular Electrical Stimulation in Adults With Chronic Kidney Disease: A Randomized Controlled Pilot Clinical Trial.

IF 2.3 3区 医学 Q3 ENGINEERING, BIOMEDICAL
Mariana Rios Rosa, Vitoria Silva de Souza, Flavia Marini Paro, Daniella Cristina De Assis Pinto Gomes, Michelly Louise Sartório Altoé Toledo, Alexandre Bittencourt Pedreira, Halina Duarte, Veronica Lourenço Wittmer, Marcela Cangussu Barbalho Moulim
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Abstract

Purpose: To assess the safety and feasibility of an intradialytic exercise protocol, including unilateral upper limb neuromuscular electrical stimulation (NMES) superimposed on a voluntary contraction combined with leg cycle ergometer exercise, in adults with chronic kidney disease (CKD).

Methods: This was a pilot randomized clinical trial in which patients with CKD underwent an intradialytic exercise protocol using a cycle ergometer and active upper limb NMES in the intervention group (IG) or cycle ergometer and SHAM in the control group (CG). Safety was assessed by monitoring blood pressure, heart rate (HR), peripheral oxygen saturation, and any abnormal signs or adverse events. Feasibility was evaluated based on the rate of adherence to the protocol, number of dropouts, and protocol acceptability by patients and healthcare teams.

Results: HR increased in both groups during exercise, but there was no difference between the groups. The post-exercise HR remained higher than the initial HR only in the IG (p = 0.04), and the post-exercise systolic blood pressure (SBP) was lower than the initial SBP only in the CG (p = 0.05); however, these variables remained within the safety values. The adherence rate was 87.5% in the IG and 82.29% in the CG, with no reported adverse events, and the majority expressed interest in continuing exercise after the end of the study, with positive acceptance from the healthcare staff at the HD center.

Conclusion: This intradialytic exercise protocol, including active upper limb NMES, seems to be safe and feasible, suggesting that NMES may be incorporated into intradialytic protocols.

Trial registration: ClinicalTrials.gov identifier: NCT05374863.

包括上肢神经肌肉电刺激在内的透析内运动对成人慢性肾病患者的安全性和可行性:一项随机对照先导临床试验
目的:评估一种溶栓运动方案的安全性和可行性,包括单侧上肢神经肌肉电刺激(NMES)叠加自主收缩结合腿周期测力仪运动,用于慢性肾病(CKD)成人患者。方法:这是一项试点随机临床试验,CKD患者在干预组(IG)或对照组(CG)中使用循环劳力计和主动上肢NMES进行分析性运动方案。通过监测血压、心率(HR)、外周氧饱和度和任何异常体征或不良事件来评估安全性。可行性评估基于方案的遵守率、退出人数以及患者和医疗团队对方案的接受程度。结果:两组在运动过程中HR均有所增加,但两组间无明显差异。运动后HR仅在大鼠IG组高于初始HR (p = 0.04),运动后收缩压(SBP)仅在大鼠CG组低于初始收缩压(p = 0.05);然而,这些变量仍然在安全值之内。IG组和CG组的依从率分别为87.5%和82.29%,无不良事件报告,大多数人在研究结束后表示有兴趣继续锻炼,HD中心的医护人员也积极接受。结论:包括主动上肢NMES在内的分析内运动方案似乎是安全可行的,这表明NMES可以纳入分析内方案。试验注册:ClinicalTrials.gov标识符:NCT05374863。
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来源期刊
Artificial organs
Artificial organs 工程技术-工程:生物医学
CiteScore
4.30
自引率
12.50%
发文量
303
审稿时长
4-8 weeks
期刊介绍: Artificial Organs is the official peer reviewed journal of The International Federation for Artificial Organs (Members of the Federation are: The American Society for Artificial Internal Organs, The European Society for Artificial Organs, and The Japanese Society for Artificial Organs), The International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, The International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation. Artificial Organs publishes original research articles dealing with developments in artificial organs applications and treatment modalities and their clinical applications worldwide. Membership in the Societies listed above is not a prerequisite for publication. Articles are published without charge to the author except for color figures and excess page charges as noted.
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