Department of Respiratory Sciences, University of Leicester, Leicester, UK
Department of Research and Innovation, University Hospitals of Leicester NHS Trust, Leicester, UK.
BMJ Open. 2020 Nov 3;10(11):e041227. doi: 10.1136/bmjopen-2020-041227.
Frailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.
Mixed-methods feasibility.
Prevalent adult HD patients of the trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.
Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).
Primary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.
124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.
A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.
ISRCTN11299707; ISRCTN12840463.
衰弱在血液透析(HD)患者中非常普遍,导致预后不良。本研究旨在确定针对脆弱 HD 患者的透析中运动随机对照试验(RCT)是否可行,并探讨如何根据他们的需求调整干预措施。
混合方法可行性研究。
试验中具有临床虚弱量表评分 4-7 分(易患严重虚弱)的成年 HD 患者符合可行性研究的条件。
运动组的参与者接受了 6 个月的每周 3 次、渐进式、中等强度的透析内自行车运动(IDC)。
主要结局与可行性相关。次要结局为从基线到干预完成后 1 年的跌倒发生率,以及在基线和 6 个月时测量的运动能力、身体功能、身体活动和患者报告的结局。通过对 n=25 名既参加(n=13,52%)又拒绝(n=12,48%)试验的脆弱 HD 患者的日记和访谈,探讨了试验程序和干预措施的可接受性。
共有 124 名(30%)患者符合条件,其中 64 名(52%)同意参加,51 名(80%)随后完成了基线评估。n=24(71%男性;59±13 岁)在随机分配到运动的班次中进行透析,n=27(81%男性;65±11 岁)在分配到常规护理的班次中进行透析。n=6(12%)患者失访。运动组完成了 74%的课程。27%-89%的次要结局数据缺失。脆弱的 HD 患者概述了几种增强试验程序的方法。维持日常生活活动和社会参与的能力是首要的结局。参与者希望有一个多样化的运动方案。
明确的 RCT 是可行的,然而,与 IDC 相比,综合运动方案可能对该人群更有效。
ISRCTN11299707;ISRCTN12840463。