Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients
- Conditions
- Physical InactivityChronic Kidney DiseasesCognitive Dysfunction
- Interventions
- Other: Cognitive and physical exercise training
- Registration Number
- NCT05150444
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive and physical exercise training Cognitive and physical exercise training 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).
- Primary Outcome Measures
Name Time Method Change in Test of Attentional Performance (TAP) score 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 Outcome Measures
Name Time Method Change in Symbol Digit Modalities Test (SDMT) score 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.
Change in 10 repetition sit-to-stand test time 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.
Change in Montreal Cognitive Assessment (MoCA) score 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.
Change in Trail Making Test A and B score baseline, after 12 weeks The psychomotor speed and executive function will be measured by Trail Making Test A and B.
Change in frailty score 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.
Change in Interleukin-6 concentration baseline, after 12 weeks Interleukin-6 serum concentration
Change in albumin concentration baseline, after 12 weeks Albumin serum concentration
Change in lean tissue index baseline, after 12 weeks Lean tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care)
Change in spontaneous gait speed baseline, after 12 weeks Spontaneous gait speed test (4 meters) as a measure of functional mobility (in m/s).
Change in Stork balance test time baseline, after 12 weeks Stork balance test time as a measure of balance.
Change in timed-up-and go (TUG) test time 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).
Change in C-reactive protein (CRP) concentration baseline, after 12 weeks C-reactive protein serum concentration
Change in fat tissue index baseline, after 12 weeks Fat tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care)
Change in creatinine concentration baseline, after 12 weeks Creatinine serum concentration
Change in sodium concentration baseline, after 12 weeks Sodium serum concentration
Change in potassium concentration baseline, after 12 weeks Potassium serum concentration
Change in handgrip strength (HGS) test baseline, after 12 weeks Handgrip strength test as a measure of upper body strength (in kilograms).
Change in Brain-derived neurotrophic factor (BDNF) concentration baseline, after 12 weeks BDNF is a neurotrophic protein that promotes neurons' survival and differentiation.
Change in hemoglobin concentration baseline, after 12 weeks Hemoglobin blood concentration
Change in phosphate concentration baseline, after 12 weeks Phosphate serum concentration
Change in Kidney Disease Quality of Life Short Form (KDQoL-SF) score 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).
Change in urea concentration baseline, after 12 weeks Urea serum concentration
Change in mental fatigue baseline, after 12 weeks Mental fatigue measured by Visual Analogue Scale (M-VAS) ranged 0-100, where higher score indicates higher mental fatigue.
Change in hematocrit concentration baseline, after 12 weeks Hematocrit blood concentration
Trial Locations
- Locations (1)
University Medical Centre
🇸🇮Ljubljana, Osrednjeslovenska, Slovenia