护士主导的多组分运动干预对可能或确诊肌少症的血液透析患者的效果：一项整群随机试验。
完整摘要 · 中文译文
目的：评估由护士主导的多组分运动干预对可能或确诊肌少症的血液透析患者骨骼肌功能和生活质量的潜在效果、安全性和可行性。 设计：整群随机试验，群组按固定血液透析排班定义。 方法：共纳入56名符合条件的参与者，并通过整群随机化进行分配。干预组（n = 28）在标准照护基础上接受为期12周的护士主导多组分运动干预，而对照组（n = 28）接受标准照护。主要结局包括骨骼肌质量指数（SMI）、握力、步速和简易体能状况量表（SPPB）评分。次要结局包括肾脏疾病生活质量36条目简表调查（KDQOL-36）评分和C反应蛋白水平。握力、步速、SPPB评分和KDQOL-36评分在基线和干预期间第4、8和12周时评估，而SMI和C反应蛋白在基线和第12周时评估。采用意向性治疗分析，并使用线性混合模型评价干预效果。 结果：56名参与者中，50名完成了研究。干预组在握力、步速和SPPB评分方面显示出有利趋势，效应量为中到大；然而，经Bonferroni校正后，这些差异无统计学意义。此外，在骨骼 肌肉质量指数、健康相关生活质量或C反应蛋白水平。未报告与干预相关的严重不良事件。 结论：由护士主导的多组分运动干预是安全且可行的，并在肌肉力量和身体功能方面显示出有利趋势，尽管经多重比较校正后组间差异未保持统计学显著性。 对患者护理的意义：由护士主导的多组分运动干预可能具有提高可能或确诊肌少症的血液透析患者肌肉力量和身体功能的潜力。 影响：该研究解决了什么问题？本研究评估了为可能或确诊肌少症的血液透析患者设计的由护士主导的多组分运动干预的潜在效果、安全性和可行性。主要发现是什么？由护士主导的运动干预似乎是安全且可行的，并可能有助于改善可能或确诊肌少症的血液透析患者的肌肉力量和身体功能。然而，未来需要更大样本量和更长随访期的研究来评估长期效果。该研究将在何处以及对谁产生影响？本研究结果可能为由护士主导的运动干预在肌少症血液透析患者中的开发和未来实施提供参考。 患者与公众贡献：患者和家庭成员被邀请与医疗保健专业人员合作，设计由护士主导的多组分运动 干预方案。他们的贡献有助于提高运动干预的可行性和实用性。 报告方法：本研究报告采用CONSORT 2025清单。 试验注册：本试验已在www.chictr.org.cn注册（注册号：ChiCTR2200065863）。
完整摘要 · 英文原文
AIMS: To assess the potential effects, safety and feasibility of a nurse-led multicomponent exercise intervention on skeletal muscle function and quality of life in haemodialysis patients with possible or confirmed sarcopenia. DESIGN: A cluster randomised trial with clusters defined by fixed haemodialysis schedules. METHODS: A total of 56 eligible participants were enrolled and allocated through cluster randomisation. The intervention group (n = 28) received a 12-week nurse-led multicomponent exercise intervention in addition to standard care, whereas the control group (n = 28) received standard care. The primary outcomes included skeletal muscle mass index (SMI), handgrip strength, gait speed and short physical performance battery (SPPB) scores. Secondary outcomes included scores on the Kidney Disease Quality of Life 36-Item Short-Form Survey (KDQOL-36) and C-reactive protein levels. Handgrip strength, gait speed, SPPB scores and KDQOL-36 scores were assessed at baseline and at Weeks 4, 8 and 12 during the intervention period, whereas SMI and C-reactive protein were assessed at baseline and Week 12. An intention-to-treat analysis was employed, and the effects of the intervention were evaluated using linear mixed models. RESULTS: Of the 56 participants, 50 completed the study. The intervention group showed favourable trends in handgrip strength, gait speed and SPPB scores, with moderate-to-large effect sizes; however, these differences were not statistically significant after Bonferroni correction. Furthermore, no significant between-group differences were found in skeletal muscle mass index, health-related quality of life, or C-reactive protein levels. No serious intervention-related adverse events were reported. CONCLUSIONS: The nurse-led multicomponent exercise intervention was safe and feasible and showed favourable trends in muscle strength and physical function, although statistically significant between-group differences were not retained after correction for multiple comparisons. IMPLICATIONS FOR PATIENT CARE: A nurse-led, multicomponent exercise intervention may have the potential to increase muscle strength and physical function in haemodialysis patients with possible or confirmed sarcopenia. IMPACT: What problem did the study address? This study assessed the potential effects, safety, and feasibility of a nurse-led, multicomponent exercise intervention designed for haemodialysis patients with possible or confirmed sarcopenia. What were the main findings? A nurse-led exercise intervention appeared safe and feasible and may help to improve muscle strength and physical function in haemodialysis patients with possible or confirmed sarcopenia. However, future studies with larger sample sizes and longer follow-up periods are needed to assess the long-term effects. Where and on whom will the research have an impact? The results of this study may inform the development and future implementation of nurse-led exercise interventions for haemodialysis patients with sarcopenia. PATIENT AND PUBLIC CONTRIBUTIONS: Patients and family members were invited to collaborate with healthcare professionals in designing a nurse-led, multicomponent exercise intervention programme. Their contributions helped improve the feasibility and practicality of the exercise intervention. REPORTING METHOD: The CONSORT 2025 checklist was used in the reporting of the study. TRIAL REGISTRATION: This trial was registered at www.chictr.org.cn (registration number: ChiCTR2200065863).