Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, Fujian, Fuzhou, China.
School of health, Fujian Medical University, Fuzhou, China.
BMJ Open. 2024 Nov 2;14(11):e087574. doi: 10.1136/bmjopen-2024-087574.
Respiratory dysfunction is a notable complication in stroke patients, in which the diaphragm, as the primary respiratory muscle, directly influences lung function. Repetitive peripheral magnetic stimulation (rPMS) is a new, non-invasive approach that is used to treat brain and nerve problems. Few studies have examined the effect of magnetic stimulation on the phrenic nerve, breathing and diaphragm in stroke patients. This study aims to assess the effect of magnetic phrenic nerve stimulation on respiratory muscle function and lung function in adults with stroke. The results of this study may provide a promising approach to managing respiratory dysfunction in stroke patients.
This randomised controlled trial is designed to compare the effectiveness of bilateral magnetic phrenic nerve stimulation (rPMS) and conventional rehabilitation training in enhancing respiratory muscle strength, lung function indicators, diaphragmatic excursion and diaphragm thickness in patients with respiratory muscle weakness. Thirty patients admitted to the First Hospital of Fujian Medical University will be included in this study. Participants in the intervention group will undergo daily bilateral magnetic phrenic nerve stimulation for 2 weeks. Stimulation will be administered at a frequency of 25 Hz, with a pulse duration of 1.1 s and an inter-pulse interval of 5.9 s, for 5 days each week. Primary outcome measures will be assessed at baseline and after 2 weeks (end of the intervention) to evaluate the efficacy of rPMS compared with conventional rehabilitation techniques.
Before commencing the study, all participants will receive a comprehensive explanation of the study procedures, including the assessments. They will also be provided informed consent forms for review, completion and signing. This study was approved by the Ethics Committee for Research at the First Affiliated Hospital of Fujian Medical University (No.: MRCTA, ECFAH of FMU [2021]641, dated 10 November 2023) (Appendix Ⅰ & Ⅱ). The trial protocol will strictly adhere to the Uniform Standards for Reporting of Trials (CONSORT) statement. The trial has been registered with the Chinese Clinical Trial Registry.Dissemination of individual findings for each participant will be available at the end of the study. The findings will be disseminated to different interest groups, participants or other patients with respiratory dysfunction through journal papers and/or conference presentations. The results of the primary trial will be submitted for publication in a peer-reviewed journal.
ChiCTR2300075669, registered on 12 September 2023.
呼吸功能障碍是中风患者的一个显著并发症，其中膈肌作为主要呼吸肌，直接影响肺功能。重复外周磁刺激（rPMS）是一种新的非侵入性方法，用于治疗大脑和神经问题。很少有研究探讨磁刺激对中风患者膈神经、呼吸和膈肌的影响。本研究旨在评估磁膈神经刺激对成人中风患者呼吸肌功能和肺功能的影响。这项研究的结果可能为管理中风患者的呼吸功能障碍提供一种有前途的方法。
这是一项随机对照试验，旨在比较双侧磁膈神经刺激（rPMS）和常规康复训练在增强呼吸肌力量、肺功能指标、膈肌活动度和膈肌厚度方面的效果，以治疗呼吸肌无力的患者。这项研究将纳入 30 名福建医科大学附属第一医院收治的患者。干预组的参与者将接受为期 2 周的每日双侧磁膈神经刺激。刺激频率为 25Hz，脉冲持续时间为 1.1s，脉冲间隔为 5.9s，每周 5 天。主要结局指标将在基线和 2 周后（干预结束时）进行评估，以评估 rPMS 与常规康复技术相比的疗效。
在开始研究之前，所有参与者将收到一份关于研究程序的全面解释，包括评估。他们还将收到知情同意书供审查、完成和签署。这项研究得到了福建医科大学附属第一医院伦理委员会的批准（编号：MRCTA，ECFAH of FMU [2021]641，日期：2023 年 11 月 10 日）（附录Ⅰ和Ⅱ）。试验方案将严格遵循统一的临床试验报告标准（CONSORT）声明。该试验已在中国临床试验注册中心注册。在研究结束时，将提供每个参与者的个体发现的传播。研究结果将通过期刊文章和/或会议报告传播给不同的利益团体、参与者或其他有呼吸功能障碍的患者。主要试验的结果将提交给同行评议期刊发表。
ChiCTR2300075669，注册于 2023 年 9 月 12 日。
