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Completed

NCT Number: NCT05150444

Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients

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.

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Key information

Conditions

Cognitive Dysfunction Behavior Chronic Disease Chronic Kidney Diseases Cognition Disorders Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Motor Activity Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Inactivity Renal Insufficiency Renal Insufficiency, Chronic Sedentary Behavior Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre

Ljubljana, Osrednjeslovenska, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Change in Test of Attentional Performance (TAP) score

    Time frame: 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.

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) score

    Time frame: baseline, after 12 weeks

    Montreal Cognitive Assessment (MoCA) is a global cognitive function assessment tool covering eight cognitive domains and is used to screen patients for cognitive impairment.

  2. Change in Trail Making Test A and B score

    Time frame: baseline, after 12 weeks

    The psychomotor speed and executive function will be measured by Trail Making Test A and B.

  3. Change in Symbol Digit Modalities Test (SDMT) score

    Time frame: baseline, after 12 weeks

    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.

  4. Change in 10 repetition sit-to-stand test time

    Time frame: baseline, after 12 weeks

    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.

  5. Change in Stork balance test time

    Time frame: baseline, after 12 weeks

    Stork balance test time as a measure of balance.

  6. Change in frailty score

    Time frame: baseline, after 12 weeks

    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.

  7. Change in timed-up-and go (TUG) test time

    Time frame: baseline, after 12 weeks

    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).

  8. Change in handgrip strength (HGS) test

    Time frame: baseline, after 12 weeks

    Handgrip strength test as a measure of upper body strength (in kilograms).

  9. Change in Kidney Disease Quality of Life Short Form (KDQoL-SF) score

    Time frame: baseline, after 12 weeks

    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).

  10. Change in spontaneous gait speed

    Time frame: baseline, after 12 weeks

    Spontaneous gait speed test (4 meters) as a measure of functional mobility (in m/s).

  11. Change in Brain-derived neurotrophic factor (BDNF) concentration

    Time frame: baseline, after 12 weeks

    BDNF is a neurotrophic protein that promotes neurons' survival and differentiation.

  12. Change in Interleukin-6 concentration

    Time frame: baseline, after 12 weeks

    Interleukin-6 serum concentration

  13. Change in C-reactive protein (CRP) concentration

    Time frame: baseline, after 12 weeks

    C-reactive protein serum concentration

  14. Change in hemoglobin concentration

    Time frame: baseline, after 12 weeks

    Hemoglobin blood concentration

  15. Change in urea concentration

    Time frame: baseline, after 12 weeks

    Urea serum concentration

  16. Change in phosphate concentration

    Time frame: baseline, after 12 weeks

    Phosphate serum concentration

  17. Change in albumin concentration

    Time frame: baseline, after 12 weeks

    Albumin serum concentration

  18. Change in fat tissue index

    Time frame: baseline, after 12 weeks

    Fat tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care)

  19. Change in lean tissue index

    Time frame: baseline, after 12 weeks

    Lean tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care)

  20. Change in mental fatigue

    Time frame: baseline, after 12 weeks

    Mental fatigue measured by Visual Analogue Scale (M-VAS) ranged 0-100, where higher score indicates higher mental fatigue.

  21. Change in hematocrit concentration

    Time frame: baseline, after 12 weeks

    Hematocrit blood concentration

  22. Change in creatinine concentration

    Time frame: baseline, after 12 weeks

    Creatinine serum concentration

  23. Change in sodium concentration

    Time frame: baseline, after 12 weeks

    Sodium serum concentration

  24. Change in potassium concentration

    Time frame: baseline, after 12 weeks

    Potassium serum concentration

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients: Randomized Interventional Trial

Acronym: DIAKOG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2021
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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