干预以保留认知功能试验（IMPCT）研究方案：一项多透析中心 2x2 析因随机对照试验，旨在通过透析中认知和运动训练来保留认知功能。
Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function.
机构信息
Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615, N. Wolfe St, W6033, Baltimore, MD, 21205, USA.
出版信息
BMC Nephrol. 2020 Sep 3;21(1):383. doi: 10.1186/s12882-020-02041-y.
BACKGROUND
Kidney disease and dialysis significantly impact cognitive function across the age spectrum. Cognitive training (CT) and/or exercise training (ET) are promising approaches to preserve cognitive function among community-dwelling older adults, but have not been tested for cognition preservation in hemodialysis patients of all ages. In this manuscript, we summarize the protocol for the Interventions Made to Preserve Cognitive Function Trial (IMPCT).
METHODS
We will perform a 2 × 2 factorial randomized controlled trial (RCT) of eligible adult (≥18 years) hemodialysis initiates (n = 200) to test whether intradialytic CT (brain games on a tablet PC), ET (foot peddlers) and combined CT + ET while undergoing hemodialysis preserves executive function compared to standard of care (SC). Participants will engage in the interventions to which they are randomized for 6 months. The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed. This primary outcome was selected based on findings from our pilot study. The secondary objectives are to compare the risk of secondary cognitive outcomes, ESKD-specific clinical outcomes, and patient-centered outcomes at 3-months and 6-months. All data collection and interventions are conducted in the dialysis center.
DISCUSSION
We hypothesize that receiving intradialytic CT or ET will better preserve executive function than SC but receiving combined CT + ET, will be the most effective intervention. The current trial will be an important step in understanding how intradialytic interventions might preserve cognitive health.
TRIAL REGISTRATION
Clinicaltrials.Gov (Date: 8/6/18): # NCT03616535 . Protocol Version: 10 (April 2020).
FUNDING
NIDDK R01DK114074.
背景
肾脏疾病和透析会严重影响整个年龄段的认知功能。认知训练 (CT) 和/或运动训练 (ET) 是保留社区居住的老年人认知功能的有前途的方法，但尚未在所有年龄段的血液透析患者中进行认知功能保留的测试。在本文中，我们总结了保留认知功能试验 (IMPCT) 的方案。
方法
我们将对符合条件的成年 (≥18 岁) 血液透析患者 (n=200) 进行 2×2 析因随机对照试验 (RCT)，以测试在血液透析过程中进行的透析内 CT(平板电脑上的脑游戏)、ET(脚踏车)和联合 CT+ET 是否比标准护理 (SC) 更能保留执行功能。参与者将参与他们随机分配的干预措施 6 个月。主要目的是比较干预措施之间使用 Trail Making Test A (TMTA) 和 B (TMTB) 衡量的执行功能在 3 个月时的变化；具体来说，执行功能是通过 TMTB-TMTA 计算得出的，以考虑心理运动速度。这一主要结果是基于我们的初步研究结果选择的。次要目标是在 3 个月和 6 个月时比较继发性认知结果、ESKD 特定临床结果和患者为中心的结果的风险。所有数据收集和干预措施都在透析中心进行。
讨论
我们假设接受透析内 CT 或 ET 将比 SC 更好地保留执行功能，但接受联合 CT+ET 将是最有效的干预措施。目前的试验将是了解透析内干预措施如何保持认知健康的重要一步。
试验注册
Clinicaltrials.Gov (日期：2018 年 8 月 6 日)：#NCT03616535。方案版本：10(2020 年 4 月)。
资金
NIDDK R01DK114074。
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