Division of General Internal Medicine and Pediatrics, Department of Medicine, Vanderbilt University Medical Center, Vanderbilt Center for Health Services Research, Nashville, Tennessee; Osher Center for Integrative Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.
Division of General Internal Medicine and Pediatrics, Department of Medicine, Vanderbilt University Medical Center, Vanderbilt Center for Health Services Research, Nashville, Tennessee.
J Ren Nutr. 2015 Sep;25(5):445-53. doi: 10.1053/j.jrn.2015.02.004. Epub 2015 Apr 11.
Patients with end-stage renal disease on maintenance hemodialysis are much more sedentary than healthy individuals. The purpose of this study was to assess the feasibility and safety of a 12-week intradialysis yoga intervention versus a kidney education intervention on the promotion of physical activity.
We randomized participants by dialysis shift to either 12-week intradialysis yoga or an educational intervention. Intradialysis yoga was provided by yoga teachers to participants while receiving hemodialysis. Participants receiving the 12-week educational intervention received a modification of a previously developed comprehensive educational program for patients with kidney disease (Kidney School). The primary outcome for this study was feasibility based on recruitment and adherence to the interventions and safety of intradialysis yoga. Secondary outcomes were to determine the feasibility of administering questionnaires at baseline and 12 weeks including the Kidney Disease-Related Quality of Life-36.
Among 56 eligible patients who approached for the study, 31 (55%) were interested and consented to participation, with 18 assigned to intradialysis yoga and 13 to the educational program. A total of 5 participants withdrew from the pilot study, all from the intradialysis yoga group. Two of these participants reported no further interest in participation. Three withdrawn participants switched dialysis times and therefore could no longer receive intradialysis yoga. As a result, 13 of 18 (72%) and 13 of 13 (100%) participants completed 12-week intradialysis yoga and educational programs, respectively. There were no adverse events related to intradialysis yoga. Intervention participants practiced yoga for a median of 21 sessions (70% participation frequency), with 60% of participants practicing at least 2 times a week. Participants in the educational program completed a median of 30 sessions (83% participation frequency). Of participants who completed the study (n = 26), baseline and 12-week questionnaires were obtained from 85%.
Our pilot study of 12-week intradialysis yoga and 12-week educational intervention reached recruitment goals but with less than targeted completion and adherence to intervention rates. This study provided valuable feasibility data to increase follow-up and adherence for future clinical trials to compare efficacy.
终末期肾病维持性血液透析患者比健康个体更久坐不动。本研究旨在评估 12 周透析内瑜伽干预与肾脏教育干预对促进身体活动的可行性和安全性。
我们按透析班次将参与者随机分为 12 周透析内瑜伽组或教育干预组。透析内瑜伽由瑜伽老师在接受血液透析时为参与者提供。接受 12 周教育干预的参与者接受了之前为肾病患者开发的综合教育计划(肾脏病学校)的修改版。本研究的主要结果是基于对干预措施的招募和依从性的可行性以及透析内瑜伽的安全性。次要结果是确定在基线和 12 周时管理问卷的可行性,包括肾脏病相关生活质量-36。
在 56 名符合研究条件的合格患者中,有 31 名(55%)表示有兴趣并同意参与,其中 18 名被分配到透析内瑜伽组,13 名被分配到教育组。共有 5 名参与者退出了试点研究,均来自透析内瑜伽组。其中 2 名参与者表示不再有兴趣参与。3 名退出的参与者改变了透析时间,因此无法再接受透析内瑜伽。因此,18 名参与者中有 13 名(72%)和 13 名参与者(100%)分别完成了 12 周的透析内瑜伽和教育计划。没有与透析内瑜伽相关的不良事件。干预参与者中位数练习瑜伽 21 次(参与频率 70%),其中 60%的参与者每周至少练习 2 次。参加教育计划的参与者中位数完成 30 次(参与频率 83%)。完成研究的 26 名参与者(n=26)中,有 85%获得了基线和 12 周的问卷。
我们对 12 周透析内瑜伽和 12 周教育干预的试点研究达到了招募目标,但完成和坚持干预的目标率低于预期。本研究提供了有价值的可行性数据,以增加后续和坚持率,为未来比较疗效的临床试验提供参考。