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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive and physical exercise training | Experimental | This group will perform combined intradialytic cognitive and physical exercise training. First, they will exercise during dialysis (3 times a week; 12 weeks) for ~30 minutes on a customized ergometer. They will start with a 3-min warm-up, then the resistance will be implied to each individual according to the rate of perceived exertion of 4th to 5th grade on a 10-grade Borg scale. After a break, they will be given tablet computers in order to play "brain games" on a CogniFit platform (~30 - 45 min). |
|
| Standard care | No Intervention | This group will receive standard hemodialysis care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive and physical exercise training | Other | 12 weeks (3 times a week): patients will cycle on an adapted ergometer during their dialysis procedure. The exercise program will be run by kinesiologists. Participants will start with 15 minutes of cycling and then gradually increase the time and intensity. After the physical exercise session, they will continue with cognitive training. This training will be done on a tablet computer on a CogniFit platform (~30 minutes). The "brain games" on mentioned platform automatically adapt to individual cognitive abilities. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Trail Making Test A and B score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jadranka Buturović Ponikvar, PhD | University Medical Centre Ljubljana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre | Ljubljana | Osrednjeslovenska | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35145465 | Derived | Bogataj S, Trajkovic N, Pajek M, Pajek J. Effects of Intradialytic Cognitive and Physical Exercise Training on Cognitive and Physical Abilities in Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial. Front Psychol. 2022 Jan 25;13:835486. doi: 10.3389/fpsyg.2022.835486. eCollection 2022. |
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The psychomotor speed and executive function will be measured by Trail Making Test A and B. |
| baseline, after 12 weeks |
| 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 |
| 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 |
| Change in Stork balance test time | Stork balance test time as a measure of balance. | baseline, after 12 weeks |
| 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 |
| 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 |
| Change in handgrip strength (HGS) test | Handgrip strength test as a measure of upper body strength (in kilograms). | baseline, after 12 weeks |
| 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 |
| Change in spontaneous gait speed | Spontaneous gait speed test (4 meters) as a measure of functional mobility (in m/s). | baseline, after 12 weeks |
| Change in Brain-derived neurotrophic factor (BDNF) concentration | BDNF is a neurotrophic protein that promotes neurons' survival and differentiation. | baseline, after 12 weeks |
| Change in Interleukin-6 concentration | Interleukin-6 serum concentration | baseline, after 12 weeks |
| Change in C-reactive protein (CRP) concentration | C-reactive protein serum concentration | baseline, after 12 weeks |
| Change in hemoglobin concentration | Hemoglobin blood concentration | baseline, after 12 weeks |
| Change in urea concentration | Urea serum concentration | baseline, after 12 weeks |
| Change in phosphate concentration | Phosphate serum concentration | baseline, after 12 weeks |
| Change in albumin concentration | Albumin serum concentration | baseline, after 12 weeks |
| Change in fat tissue index | Fat tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care) | baseline, after 12 weeks |
| Change in lean tissue index | Lean tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care) | baseline, after 12 weeks |
| 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 |
| Change in hematocrit concentration | Hematocrit blood concentration | baseline, after 12 weeks |
| Change in creatinine concentration | Creatinine serum concentration | baseline, after 12 weeks |
| Change in sodium concentration | Sodium serum concentration | baseline, after 12 weeks |
| Change in potassium concentration | Potassium serum concentration | baseline, after 12 weeks |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D057185 | Sedentary Behavior |
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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