Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar,' Technical University Munich, Munich, Germany.
Kuratorium für Dialyse und Nierentransplantation e.V. (KfH), Bischofswerda, Germany.
NEJM Evid. 2023 Sep;2(9):EVIDoa2300057. doi: 10.1056/EVIDoa2300057. Epub 2023 Jun 17.
Patients with kidney failure undergoing hemodialysis experience physical deconditioning and multimorbidity. Exercise interventions may mitigate this outcome, but their clinical role is unclear. METHODS: This multicenter, cluster randomized controlled trial evaluated combined endurance and resistance exercise training during hemodialysis versus usual care in chronic kidney failure. It assessed physical functioning, quality of life, hospitalizations, and overall survival. The primary outcome was the change in the 60-second sit-to-stand test (STS60) between baseline and 12 months. RESULTS: A total of 1211 patients underwent randomization, 917 (65.9±14.4 years; 38.9% female) of whom were included in the full analysis (exercise intervention, n=446; usual care, n=471). At 12 months, the STS60 repetitions improved from 16.2±7.6 to 19.2±9.1 in the exercise group but declined from 16.2±7.1 to 14.7±7.9 in the usual care group (group difference, 3.85 repetitions; 95% confidence interval [CI], 2.22 to 5.48; P<0.0001). The timed up-and-go test (−1.1 seconds; 95% CI, −1.9 to −0.3) and the 6-minute walk test (37.5 m; 95% CI, 14.7 to 60.4) also differed in the exercise group versus usual care group. The physical summary score and vitality subscale of the quality of life questionnaire (i.e., the 36-item Short Form Health Survey) differed in the exercise group versus usual care group, but the other subscales did not change. Adverse events during dialysis sessions were similar in both groups. Median days spent in the hospital annually were 2 in the exercise group and 5 in the usual care group. Mortality and dialysis-specific adverse events were not affected. CONCLUSIONS: Twelve months of intradialytic exercise in patients with kidney failure significantly improved the STS60 compared with usual care. (Funded by the Innovation Fund, Federal Joint Committee; ClinicalTrials.gov number, NCT03885102.)
接受血液透析的肾衰竭患者会经历身体机能下降和多种合并症。运动干预可能会改善这种结果,但它们的临床作用尚不清楚。方法:这项多中心、集群随机对照试验评估了血液透析期间的联合耐力和抗阻运动训练与慢性肾衰竭的常规护理相比的效果。它评估了身体机能、生活质量、住院和总生存情况。主要结局是在基线和 12 个月时的 60 秒坐站测试(STS60)的变化。结果:共有 1211 名患者进行了随机分组,917 名(65.9±14.4 岁;38.9%为女性)患者纳入全分析集(运动干预组 446 例,常规护理组 471 例)。在 12 个月时,运动组的 STS60 重复次数从 16.2±7.6 增加到 19.2±9.1,但常规护理组从 16.2±7.1 减少到 14.7±7.9(组间差异,3.85 次;95%置信区间,2.22 至 5.48;P<0.0001)。计时起立行走测试(−1.1 秒;95%置信区间,−1.9 至 −0.3)和 6 分钟步行测试(37.5 米;95%置信区间,14.7 至 60.4)在运动组与常规护理组之间也存在差异。运动组与常规护理组的生活质量问卷(即 36 项简短健康调查问卷)的身体综合评分和活力分量表存在差异,但其他分量表没有变化。两组在透析过程中的不良事件相似。运动组每年住院天数中位数为 2 天,常规护理组为 5 天。死亡率和透析相关不良事件不受影响。结论:在肾衰竭患者中进行 12 个月的血液透析期间运动显著改善了 STS60,与常规护理相比。(由创新基金、联邦联合委员会资助;临床试验编号,NCT03885102。)