Hemodialysis-based interventions to preserve cognitive function

以血液透析为基础的干预措施以保留认知功能

• 批准号: 10320432
• 负责人: Mara A. McAdams DeMarco
• 金额: $ 6.02万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-09 至 2022-02-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10320432
• 关键词: Adult; Anxiety; Cessation of life; Characteristics; Clinical; Cognition; Communities; Country; Dialysis procedure; Digit structure; Educational Intervention; Elderly; End stage renal failure; Enrollment; Ethnic Origin; Fatigue; Frequencies; General Population; Gerontology; Hemodialysis; Hospitalization; Hour; Hypotension; Impairment; Intention; Intervention; Kidney Diseases; Learning; Life; Measures; Mental Depression; Modality; Nephrology; Outcome; Pain interference; Patient Self-Report; Patient-Focused Outcomes; Patients; Physical Function; Provider; Quality of life; Race; Randomized; Randomized Controlled Trials; Renal dialysis; Reporting; Rest; Role; Sleep; Sleep disturbances; Testing; Time; Trail Making Test; Transplantation; adverse outcome; base; cognitive function; cognitive testing; cognitive training; disability; effective intervention; executive function; exercise training; experience; falls; feasibility testing; feasibility trial; functional decline; improved; insight; interest; mental state; mortality; preservation; prevent; primary outcome; secondary outcome; sex; standard of care; tv watching

ABSTRACT Over 640,000 US adults suffer from ESRD, >95% of whom receive hemodialysis (HD) for the rest of their life or until transplantation. Kidney disease and HD significantly impact cognitive function, especially higher-order executive function. Only 13% of HD patients have normal cognition; HD patients experience executive function impairment at a rate 3-fold higher than the general population, leading to hospitalization, disability, and death. Studies of older adults suggest that the only effective interventions for preserving executive function are cognitive training (CT) and/or exercise training (ET). These modalities have not been tested for executive function preservation in HD patients; even younger HD patients suffer substantial executive function impairment and could benefit from these interventions. HD frequency (3 sessions a week) and duration (4-6 hours/session) makes HD patients a “captive audience” for intradialytic CT and/or ET to mitigate executive function decline. In preliminary studies, HD patients reported spending most of their time watching TV; intradialytic CT and/or ET could replace these passive activities. In preliminary studies, 87% of nephrology providers believed that their patients would be interested in intradialytic CT and 83% believed that their patients would be interested in intradialytic ET. Among HD patients, 67% wanted to improve their cognition through CT and 71% wanted to improve their strength and cognition through ET while undergoing HD. To test the feasibility of intradialytic interventions, we conducted a pilot RCT of 20 HD patients, comparing standard of care to CT or ET; even in this pilot, we found that intradialytic CT and ET preserved executive function. As expected, executive function in patients receiving standard of care declined substantially by 3 months (difference=47.4 seconds, P=0.006); however, this decline was not seen among those receiving CT or ET. Compared with standard of care, the difference in mean change was -46.72 seconds (95% CI: -91.12, - 2.31; P=0.04) for CT and -56.21 seconds (95% CI: -105.86, -6.56; P=0.03) for ET. In just 3 months, CT and ET preserved executive function compared to a striking decline with standard of care. To properly test the impact of intradialytic CT and/or ET, on the executive function decline associated with HD, we propose the following aims: 1) To conduct an RCT to evaluate executive function decline in the setting of intradialytic CT and/or ET, 2) To quantify the effects of intradialytic CT and/or ET on ESRD-specific clinical outcomes, 3) To quantify the effects of intradialytic CT and/or ET, on patient-centered outcomes. Through this RCT, we will learn the impact of two potential non-pharmacological interventions, cognitive and exercise training, in preserving executive function during HD. If successful, this will improve HD outcomes of >640,000 adults with ESRD. For the first time, we will have validated, beneficial activities replace the typical passive activities of HD patients. Our findings will be implementable in dialysis centers across the country to help reduce the decline in executive function.

抽象的 超过64万名美国成年人患有ESRD，> 95％的人一生都接受血液透析（HD）或 直到移植。肾脏疾病和HD显着影响认知功能，尤其是高阶 执行功能。只有13％的HD患者患有正常的认知；高清患者经历执行功能 损害比一般人群高3倍，导致住院，残疾和死亡。 对老年人的研究表明，保存执行功能的唯一有效干预措施是 认知训练（CT）和/或运动培训（ET）。这些方式尚未测试过高管 高清患者的功能保留；即使是年轻的高清患者，执行功能也很大 损害，可以从这些干预措施中受益。高清频率（每周3次）和持续时间（4-6 小时/会议）使高清患者成为乳中CT和/或ET的“圈养受众”，以减轻高管 功能下降。在初步研究中，高清患者报告大部分时间看电视。 子宫内CT和/或ET可以取代这些被动活动。在初步研究中，有87％的肾脏病 提供者认为他们的患者对同烯性CT和83％的患者有兴趣。 患者将对归酯内的ET感兴趣。在高清患者中，有67％的患者想改善其认知 通过CT和71％的人希望通过ET进行高清时通过ET提高其强度和认知。 为了测试酯内干预措施的可行性，我们进行了20个HD患者的试验RCT，进行了比较 CT或ET的护理标准；即使在这个飞行员中，我们也发现莱准内部的CT和ET保留了执行 功能。正如预期的那样，接受护理标准的患者的执行功能大大下降了3 月份（差异= 47.4秒，p = 0.006）;但是，在接收CT或 等。与护理标准相比，平均变化的差异为-46.72秒（95％CI：-91.12， - 2.31; CT和-56.21秒（95％CI：-105.86，-6.56; P = 0.03）的P = 0.04）。在短短三个月内，CT和ET 与护理标准的罢工下降相比，保留的执行功能相比。 为了正确测试同烯性CT和/或ET的影响，对与HD相关的执行功能下降， 我们提出以下目的：1）进行RCT，以评估执行功能的下降 鉴别内CT和/或ET，2）量化子宫内CT和/或ET对ESRD特异性临床的影响 结局，3）量化酯内CT和/或ET的影响对以患者为中心的结果。 通过此RCT，我们将学习两种潜在的非药理学干预措施的影响，即认知和 锻炼训练，在高清期间保存执行功能方面。如果成功，这将改善 ESRD> 640,000名成年人。我们将第一次验证，有益的活动取代典型的活动 高清患者的被动活动。我们的发现将在全国各地的透析中心实施 帮助减少执行功能的下降。