Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients: Randomized Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Test of Attentional Performance (TAP) score
研究概览
简要总结
The aim of this study is to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance and frailty indicators in the hemodialysis population.
详细描述
The prevalence of cognitive impairment in hemodialysis (HD) patients is extremely high. Despite the well-documented benefits of interventions on cognitive function, there is a widespread call for effective strategies that will show the long-term consequences in patients undergoing dialysis. A randomized controlled intervention trial to examine the effects of a combined non-pharmacological intervention in the form of intradialytic physical exercise and intradialytic cognitive training on cognitive function, indicators of frailty, and physical performance measures in HD patients will be conducted. The group of patients receiving the study intervention will be compared to the control group receiving standard HD care. The duration of the intervention will be 12 weeks (3 days a week). We will use sensitive instruments (cognitive domain tests) to assess cognitive functions. The primary outcome of the study at 12 weeks will be performance on the Alertness subtest of the computerized Test of Attentional Performance. Secondary study outcomes will be: Performance in other domains of cognitive function (executive function, psychomotor speed, information processing efficiency, working memory, attention), physical fitness (10 repetition sit-to-stand test, timed up and go test, handgrip strength test, spontaneous gait speed, Stork balance test), and assessment of frailty (Edmonton Frail Scale). Study outcomes will be assessed at baseline and immediately after the 12-week intervention. This study will be among the first to test the synergistic effects of a uniquely designed physical exercise and cognitive training intervention on functional status in HD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dialysis patients on renal replacement therapy with chronic hemodialysis
- •duration of hemodialysis treatment for at least 3 months
- •capable of independent walking and independent feeding
排除标准
- •the presence of chronic malignant or infectious disease
- •uncontrolled arterial hypertension with an average of the last five pre-dialysis blood pressure values above 180/100 mm Hg,
- •unstable angina pectoris or Canadian Cardiovascular Society class 2-4,
- •heart failure New York Heart Association class 3 and 4,
- •the presence of a psychotic illness or a mental disability,
- •a condition with an amputated limb (more than 2 fingers on the lower limb and / or more than 2 fingers on the upper limb)
- •any other condition that causes the clinical unstability of the patient (i.e. repetitive gastrointestinal hemorrhagies, liver cirrhosis with frequent exacerbations)
结局指标
主要结局
Change in Test of Attentional Performance (TAP) score
时间窗: baseline, after 12 weeks
The Test of Attentional Performance (TAP) is a software package that can be used primarily to examine attention functions. The rationale for the selection of the main outcome: low learning effect, most probably affected by physical exercise, attention is one of the most affected cognitive domains in dialysis patients. From the TAP test battery, subtests Alertness, Selective attention, and Divided attention will be included.
次要结局
- Change in Symbol Digit Modalities Test (SDMT) score(baseline, after 12 weeks)
- Change in 10 repetition sit-to-stand test time(baseline, after 12 weeks)
- Change in Montreal Cognitive Assessment (MoCA) score(baseline, after 12 weeks)
- Change in Trail Making Test A and B score(baseline, after 12 weeks)
- Change in frailty score(baseline, after 12 weeks)
- Change in Interleukin-6 concentration(baseline, after 12 weeks)
- Change in albumin concentration(baseline, after 12 weeks)
- Change in lean tissue index(baseline, after 12 weeks)
- Change in spontaneous gait speed(baseline, after 12 weeks)
- Change in Stork balance test time(baseline, after 12 weeks)
- Change in timed-up-and go (TUG) test time(baseline, after 12 weeks)
- Change in C-reactive protein (CRP) concentration(baseline, after 12 weeks)
- Change in fat tissue index(baseline, after 12 weeks)
- Change in creatinine concentration(baseline, after 12 weeks)
- Change in sodium concentration(baseline, after 12 weeks)
- Change in potassium concentration(baseline, after 12 weeks)
- Change in handgrip strength (HGS) test(baseline, after 12 weeks)
- Change in Brain-derived neurotrophic factor (BDNF) concentration(baseline, after 12 weeks)
- Change in hemoglobin concentration(baseline, after 12 weeks)
- Change in phosphate concentration(baseline, after 12 weeks)
- Change in Kidney Disease Quality of Life Short Form (KDQoL-SF) score(baseline, after 12 weeks)
- Change in urea concentration(baseline, after 12 weeks)
- Change in mental fatigue(baseline, after 12 weeks)
- Change in hematocrit concentration(baseline, after 12 weeks)
研究者
Špela Bogataj
Postdoctoral Researcher
University Medical Centre Ljubljana