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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Cognitive Dysfunction; Physical Inactivity
• Intervention / Treatment: Other: Cognitive and physical exercise training

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Osrednjeslovenska
    • Ljubljana, Osrednjeslovenska, Slovenia, 1000
      • University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Cognitive and physical exercise training; 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.
No Intervention: Standard care; This group will receive standard hemodialysis care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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 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 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
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 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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Chair: Jadranka Buturović Ponikvar, PhD, University Medical Centre Ljubljana

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; hemodialysis; cognitive functions; non-pharmacological interventions; intradialytic training
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Urologic Diseases; Neurocognitive Disorders; Disease Attributes; Renal Insufficiency; Cognition Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Cognitive Dysfunction
• Other Study ID Numbers: Z3-3212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No