{"title":"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","authors":"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","doi":"10.1111/aor.70006","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>This intradialytic exercise protocol, including active upper limb NMES, seems to be safe and feasible, suggesting that NMES may be incorporated into intradialytic protocols.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT05374863.</p>","PeriodicalId":8450,"journal":{"name":"Artificial organs","volume":" ","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and Feasibility of Intradialytic Exercise Including Upper Limb Neuromuscular Electrical Stimulation in Adults With Chronic Kidney Disease: A Randomized Controlled Pilot Clinical Trial.\",\"authors\":\"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\",\"doi\":\"10.1111/aor.70006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>This intradialytic exercise protocol, including active upper limb NMES, seems to be safe and feasible, suggesting that NMES may be incorporated into intradialytic protocols.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT05374863.</p>\",\"PeriodicalId\":8450,\"journal\":{\"name\":\"Artificial organs\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-08-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Artificial organs\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1111/aor.70006\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Artificial organs","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1111/aor.70006","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
Safety and Feasibility of Intradialytic Exercise Including Upper Limb Neuromuscular Electrical Stimulation in Adults With Chronic Kidney Disease: A Randomized Controlled Pilot Clinical Trial.
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.
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.