Cognitive DysfunctionDIAKOGNCT05150444
Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients
A study testing Cognitive and physical exercise training in people with Cognitive Dysfunction and Physical Inactivity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Dysfunction, Physical Inactivity, Chronic Kidney Diseases
- What is being tested?
- Cognitive and physical exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Nov 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients: Randomized Interventional Trial
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.
Read the 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.
- Being tested
- Cognitive and physical exercise training
- Keywords
- cognitive functions, hemodialysis, physical activity, intradialytic training, non-pharmacological interventions
- Medical subject headings
- Cognitive Dysfunction, Sedentary Behavior, Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and physical exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cognitive and physical exercise training |
| Standard care | No intervention | This group will receive standard hemodialysis care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after 12 weeks
Secondary outcomes (24)
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.
Measured: baseline, after 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: baseline, after 12 weeks
Change in Stork balance test time
Stork balance test time as a measure of balance.
Measured: 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.
Measured: 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).
Measured: baseline, after 12 weeks
Change in handgrip strength (HGS) test
Handgrip strength test as a measure of upper body strength (in kilograms).
Measured: 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).
Measured: baseline, after 12 weeks
Change in spontaneous gait speed
Spontaneous gait speed test (4 meters) as a measure of functional mobility (in m/s).
Measured: baseline, after 12 weeks
Change in Brain-derived neurotrophic factor (BDNF) concentration
BDNF is a neurotrophic protein that promotes neurons' survival and differentiation.
Measured: baseline, after 12 weeks
Change in Interleukin-6 concentration
Interleukin-6 serum concentration
Measured: baseline, after 12 weeks
Change in C-reactive protein (CRP) concentration
C-reactive protein serum concentration
Measured: baseline, after 12 weeks
Change in hemoglobin concentration
Hemoglobin blood concentration
Measured: baseline, after 12 weeks
Change in urea concentration
Urea serum concentration
Measured: baseline, after 12 weeks
Change in phosphate concentration
Phosphate serum concentration
Measured: baseline, after 12 weeks
Change in albumin concentration
Albumin serum concentration
Measured: baseline, after 12 weeks
Change in fat tissue index
Fat tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care)
Measured: baseline, after 12 weeks
Change in lean tissue index
Lean tissue index measured by bioimpedance analysis (BCM Fresenius Medical Care)
Measured: 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.
Measured: baseline, after 12 weeks
Change in hematocrit concentration
Hematocrit blood concentration
Measured: baseline, after 12 weeks
Change in creatinine concentration
Creatinine serum concentration
Measured: baseline, after 12 weeks
Change in sodium concentration
Sodium serum concentration
Measured: baseline, after 12 weeks
Change in potassium concentration
Potassium serum concentration
Measured: baseline, after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start2 Nov 2022
- Primary completion25 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Špela Bogataj, University Medical Centre Ljubljana
- Investigators
- Jadranka Buturović Ponikvar, PhD, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150444
- Sponsor's protocol ID
- Z3-3212
- Acronym
- DIAKOG
- Status last verified
- Feb 2024
- First submitted
- 25 Nov 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35145465
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients: Randomized Interventional Trial
- ClinicalTrials.gov ID
- NCT05150444
- Acronym / sponsor ID
- DIAKOG / Z3-3212
- Keywords
- cognitive functions, hemodialysis, physical activity, intradialytic training, non-pharmacological interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive and physical exercise training | Experimental | Other: Cognitive and physical exercise trainingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and physical exercise training12 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. | Other | Cognitive and physical exercise training |
Primary outcome
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.
24 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: baseline, after 12 weeks
Change in Trail Making Test A and B score
Time frame: baseline, after 12 weeks
Change in Symbol Digit Modalities Test (SDMT) score
Time frame: baseline, after 12 weeks
Change in 10 repetition sit-to-stand test time
Time frame: baseline, after 12 weeks
Change in Stork balance test time
Time frame: baseline, after 12 weeks
Change in frailty score
Time frame: baseline, after 12 weeks
Change in timed-up-and go (TUG) test time
Time frame: baseline, after 12 weeks
Change in handgrip strength (HGS) test
Time frame: baseline, after 12 weeks
Change in Kidney Disease Quality of Life Short Form (KDQoL-SF) score
Time frame: baseline, after 12 weeks
Change in spontaneous gait speed
Time frame: baseline, after 12 weeks
Change in Brain-derived neurotrophic factor (BDNF) concentration
Time frame: baseline, after 12 weeks
Change in Interleukin-6 concentration
Time frame: baseline, after 12 weeks
Change in C-reactive protein (CRP) concentration
Time frame: baseline, after 12 weeks
Change in hemoglobin concentration
Time frame: baseline, after 12 weeks
Change in urea concentration
Time frame: baseline, after 12 weeks
Change in phosphate concentration
Time frame: baseline, after 12 weeks
Change in albumin concentration
Time frame: baseline, after 12 weeks
Change in fat tissue index
Time frame: baseline, after 12 weeks
Change in lean tissue index
Time frame: baseline, after 12 weeks
Change in mental fatigue
Time frame: baseline, after 12 weeks
Change in hematocrit concentration
Time frame: baseline, after 12 weeks
Change in creatinine concentration
Time frame: baseline, after 12 weeks
Change in sodium concentration
Time frame: baseline, after 12 weeks
Change in potassium concentration
Time frame: baseline, after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 35145465Bogataj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jadranka Buturović Ponikvar, PhD study chair
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and physical exercise training in people with Cognitive Dysfunction and Physical Inactivity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Test of Attentional Performance (TAP) score (time frame: baseline, after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.