The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, People's Republic of China.
Department of Internal Medicine, Deqing Hospital of Traditional Chinese Medicine, Huzhou, People's Republic of China.
BMJ Open. 2024 Aug 17;14(8):e082518. doi: 10.1136/bmjopen-2023-082518.
Haemodialysis (HD) patients usually engage in a low level of physical activities, which could impact the prognosis and mortality of this group. Fitness Qigong Baduanjin, a physical exercise from traditional Chinese Medicine, is known to have benefit in chronic heart failure patients and peritoneal dialysis patients. However, researches about Baduanjin in HD patients are currently limited. So, the aim of the study is to investigate the current exercise intensity of HD patients and its influencing factors, and to explore the effects of Baduanjin on HD patients.
This prospective, non-blinded, randomised controlled trial will enrol patients with end-stage kidney disease who were stable on HD for more than 3 months. All eligible participants will be randomly divided into the intervention group undergoing Baduanjin and the control group without Baduanjin in a 1:1 ratio. The intervention group is required to perform Baduanjin two times per day, starting 30 min after breakfast and dinner, 45 min per session for a total of a 6 month, starting from 10 June 2024. Information such as laboratory biochemical examination indicators, radiological examination results and related scales and questionnaires will be collected at baseline, 1 month follow-up, 3 month follow-up and 6 month follow-up. All statistical tests are conducted through the two-tailed test, and a p-value≤0.05 will be considered statistically significant for the difference being tested. The description of quantitative indicators will be used in calculating the number of cases, mean, SD, median and IQR method. The classification indicators will be used to describe the number of cases and percentages (frequency and frequency rate).
The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (V20230521). The results will be reported in a peer-reviewed journal and a relevant academic conference.
ChiCTR2300074659.
血液透析（HD）患者通常进行低水平的身体活动，这可能会影响该人群的预后和死亡率。健身气功八段锦是一种中医传统的身体锻炼方法，已知对慢性心力衰竭患者和腹膜透析患者有益。然而，目前关于八段锦在 HD 患者中的研究有限。因此，本研究旨在调查 HD 患者目前的运动强度及其影响因素，并探讨八段锦对 HD 患者的影响。
这是一项前瞻性、非盲、随机对照试验，将纳入稳定接受 HD 治疗超过 3 个月的终末期肾病患者。所有符合条件的参与者将以 1:1 的比例随机分为接受八段锦锻炼的干预组和不接受八段锦锻炼的对照组。干预组要求每天进行两次八段锦锻炼，早餐和晚餐后 30 分钟开始，每次 45 分钟，共进行 6 个月，从 2024 年 6 月 10 日开始。在基线、1 个月随访、3 个月随访和 6 个月随访时收集实验室生化检查指标、影像学检查结果和相关量表和问卷等信息。所有统计检验均采用双侧检验，p 值≤0.05 被认为具有统计学意义。定量指标的描述将使用病例数、均值、标准差、中位数和 IQR 方法进行计算。分类指标将用于描述病例数和百分比（频率和频率率）。
该研究方案已获得浙江中医药大学第一附属医院伦理委员会的批准（V20230521）。研究结果将在同行评议的期刊和相关学术会议上报告。
ChiCTR2300074659。
