Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Test of Attentional Performance (TAP) score |
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. |
baseline, after 12 weeks |
|
Secondary |
Change in Montreal Cognitive Assessment (MoCA) score |
Montreal Cognitive Assessment (MoCA) is a global cognitive function assessment tool covering eight cognitive domains and is used to screen patients for cognitive impairment. |
baseline, after 12 weeks |
|
Secondary |
Change in Trail Making Test A and B score |
The psychomotor speed and executive function will be measured by Trail Making Test A and B. |
baseline, after 12 weeks |
|
Secondary |
Change in Symbol Digit Modalities Test (SDMT) score |
Symbol Digit Modalities Test (SDMT) will be used to assess the psychomotor speed, efficiency of information processing, ability to switch between mental sets of the information and to maintain and manipulate information in working memory. It is a reliable and valid test for assessing information processing speed and efficiency and executive functioning domains. |
baseline, after 12 weeks |
|
Secondary |
Change in 10 repetition sit-to-stand test time |
Performance of the sit-to-stand test involves activation of the lower limb muscles; the test measures lower limb strength. Participants are required to 10 times stand up from and sit down on an armless chair as quickly as possible. Their arms should be folded across their chest. |
baseline, after 12 weeks |
|
Secondary |
Change in Stork balance test time |
Stork balance test time as a measure of balance. |
baseline, after 12 weeks |
|
Secondary |
Change in frailty score |
Frailty indicator will be assessed by the Edmonton Frail Scale (EFS). The EFS score ranges from zero to 17 points. Severe Frailty is defined as a score of 12-17 possible points; apparent vulnerability is a score of 6-11 points; and non-frail is a score of 5 or less points. |
baseline, after 12 weeks |
|
Secondary |
Change in timed-up-and go (TUG) test time |
The Timed Up and Go (TUG) test is a simple evaluative test used to measure functional mobility. It will be used to estimate risk of falling and ability to maintain balance while walking and while walking and talking (TUG-dual). |
baseline, after 12 weeks |
|
Secondary |
Change in handgrip strength (HGS) test |
Handgrip strength test as a measure of upper body strength (in kilograms). |
baseline, after 12 weeks |
|
Secondary |
Change in Kidney Disease Quality of Life Short Form (KDQoL-SF) score |
Kidney Disease Quality of Life Short Form (KDQOL-SF) as a measure of quality of life. The scoring procedure first transforms the raw precoded numeric values of items to a 0-100 possible range, with higher transformed scores always reflecting better quality of life. Scores are evaluated according to summary scores: a mental component summary (MCS) and a physical component summary (PCS). |
baseline, after 12 weeks |
|
Secondary |
Change in spontaneous gait speed |
Spontaneous gait speed test (4 meters) as a measure of functional mobility (in m/s). |
baseline, after 12 weeks |
|
Secondary |
Change in Brain-derived neurotrophic factor (BDNF) concentration |
BDNF is a neurotrophic protein that promotes neurons' survival and differentiation. |
baseline, after 12 weeks |
|
Secondary |
Change in Interleukin-6 concentration |
Interleukin-6 serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in C-reactive protein (CRP) concentration |
C-reactive protein serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in hemoglobin concentration |
Hemoglobin blood concentration |
baseline, after 12 weeks |
|
Secondary |
Change in urea concentration |
Urea serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in phosphate concentration |
Phosphate serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in albumin concentration |
Albumin serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in fat tissue index |
Fat tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care) |
baseline, after 12 weeks |
|
Secondary |
Change in lean tissue index |
Lean tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care) |
baseline, after 12 weeks |
|
Secondary |
Change in mental fatigue |
Mental fatigue measured by Visual Analogue Scale (M-VAS) ranged 0-100, where higher score indicates higher mental fatigue. |
baseline, after 12 weeks |
|
Secondary |
Change in hematocrit concentration |
Hematocrit blood concentration |
baseline, after 12 weeks |
|
Secondary |
Change in creatinine concentration |
Creatinine serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in sodium concentration |
Sodium serum concentration |
baseline, after 12 weeks |
|
Secondary |
Change in potassium concentration |
Potassium serum concentration |
baseline, after 12 weeks |
|