Intradialytic Protein Supplementation & Exercise Training in Dialysis Patients

描述(由申请人提供)： 慢性肾脏病(CKD)接受血液透析治疗(CKD期5期)的患者患有多种可能与机械相关的共病疾病。蛋白质营养不良、肌肉分解代谢和消瘦尤其常见，这会导致肌肉力量下降、身体机能下降和体力活动减少。缺乏运动会加剧这些功能衰退，还会导致心血管疾病(CVD)和骨骼疾病。这种疾病和残疾的循环极大地降低了透析患者的生活质量(QOL)并增加了死亡率。传统的蛋白质补充和耐力运动训练是相对低成本的治疗方法，有可能降低这些并存疾病的患病率或严重程度，但很少有研究直接评估它们的有效性。本研究的目的是评估在传统运动训练(自行车)的同时和不结合传统运动训练(自行车)的情况下，口服蛋白质补充剂对身体功能、生活质量、心血管疾病和骨骼健康的影响。为了解决这些问题，血液透析患者将被随机分为以下组，为期12个月：1)常规护理/对照组(CON)；2)透析中补充蛋白质(PRO)；或3)透析中补充蛋白质+运动训练(PRO+EX)。身体功能、肌肉力量和生活质量将通过各种客观和主观任务进行评估，DXA将用于测量瘦质量、骨密度和腹主动脉钙化，血管超声将用于测量动脉硬度和颈动脉内中膜厚度，超声心动图将用于评估心脏结构和功能。此外，影响心血管疾病风险和肌肉和骨骼合成代谢的炎性介质、矿物质调节蛋白和生长因子的循环水平将通过标准生化分析进行测量，以评估蛋白质补充和运动训练可能影响这些共病情况的潜在机制。我们假设，在PRO+EX和PRO组中，身体功能、功能性心血管疾病结局和危险因素、骨密度和生活质量指数将发生有益的变化，而CON组则不会。此外，除与骨密度相关的变量外，这些变化在PRO+EX中的变化幅度最大。 公共卫生相关性： 这项研究将提供有关口服蛋白质补充和运动训练对透析患者的临床结果和生活质量的影响的新信息。这项研究的结果将使肾科医生能够就这些低成本治疗策略应在多大程度上作为其临床标准护理的组成部分做出更明智的决定。最终，这可能导致更多地使用这些治疗策略，并显著改善这一危重患者群体的健康和生活质量。

DESCRIPTION (provided by applicant): Chronic kidney disease (CKD) patients receiving hemodialysis treatment (CKD stage 5) suffer from a variety of co-morbid diseases that may be mechanistically related. Protein malnutrition, muscle catabolism and wasting are especially common, and these lead to reduced muscle strength, declines in physical function, and low levels of physical activity. Physical inactivity exacerbates these functional declines, and also promotes cardiovascular disease (CVD) and bone disorders. This cycle of disease and disability greatly reduces the quality of life (QOL) and increases mortality rates in dialysis patients. Intradialytic protein supplementation and endurance exercise training are relatively low-cost therapies that have the potential to reduce the prevalence or severity of these co-morbid conditions, but few studies have directly assessed their efficacy. The objective of the proposed research is to evaluate the effects of intradialytic oral protein supplementation, with and without concomitant intradialytic exercise training (cycling), on measures related to physical function, QOL, CVD, and bone health. To address these questions, hemodialysis patients will be randomized to the following groups for 12 months: 1) usual care/control (CON); 2) intradialytic protein supplementation (PRO); or 3) intradialytic protein supplementation + exercise training (PRO+EX). Physical function, muscle strength, and QOL will be assessed by a variety of objective and subjective tasks, DXA will be used to measure lean mass, bone density, and abdominal aortic calcification, vascular ultrasound will be used to measure arterial stiffness and carotid intima-media thickness, and echocardiography will be used to assess cardiac structure and function. In addition, circulating levels of inflammatory mediators, mineral regulatory proteins, and growth factors that impact CVD risk and muscle and bone anabolism will be measured by standard biochemical assays to assess potential mechanisms by which protein supplementation and exercise training may influence these co-morbid conditions. We hypothesize that beneficial changes in physical function, functional CVD outcomes and risk factors, bone density, and QOL indices will occur in PRO+EX and PRO, but not in CON. Furthermore, the magnitude of these changes will be greatest in PRO+EX for all variables except those related to bone density. PUBLIC HEALTH RELEVANCE: This study will provide novel information regarding the effects of oral protein supplementation and exercise training on clinical outcomes and the QOL in dialysis patients. Results from this study will enable nephrologists to make more informed decisions regarding the extent to which these low-cost treatment strategies should be included as a component of the standard care in their clinics. Ultimately, this could lead to greater use of these treatment strategies and result in significant improvements in the health and QOL of this critically ill patient population.