Comparing online and face-to-face Liuzijue training in stroke survivors with respiratory dysfunction: study protocol for a randomized controlled non-inferiority trial #MMPMID41331673
Ma Y; Huo Y; Yan J; Hu Z; Ye R; Luo J; Zhou X; Xu Y; Yang Z; Wang J; Yang A; Wang Y
Trials 2025[Dec]; ? (?): ? PMID41331673show ga
BACKGROUND: Stroke is a global health problem, and respiratory dysfunction post-stroke is a common complication that affects the recovery process of patients and their quality of life. In this study, we aim to investigate whether online Liuzijue training is non-inferior to the face-to-face one in terms of training efficacy and patient safety for stroke survivors with respiratory dysfunction. METHODS/DESIGN: We will recruit 64 stroke survivors with respiratory dysfunction from January 2025 and assign them randomly into control, online, and offline groups. In addition to their routine rehabilitation therapy, patients in the online and offline groups will undergo Liuzijue training once a day, 5 days a week, for 8 weeks, while those in the control group will not engage in any Liuzijue training. The primary outcomes will include the forced expiratory volume in one second and peak expiratory flow. Secondary outcomes will include the diaphragmatic thickening fraction during quiet breathing and diaphragmatic excursion during quiet breathing. All outcomes will be measured before and after the intervention. In addition, the incidence of adverse events associated with Liuzijue training will be recorded to assess the safety of the intervention. DISCUSSION: This study provides a simple, feasible, repeatable, and fun exercise training approach. To the best of our knowledge, there are no randomized controlled trials in the existing literature on internet-based respiratory exercise applied to stroke patients. The protocol presented in our study can serve as a reference for an alternative and supplementary approach to long-term inpatient respiratory rehabilitation. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR2400094537. Registered on 24 December 2024, https://www.chictr.org.cn/index.html.
Trials 2025 ; ? (?): ?
