Clinical trial NCT05150444: Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients
Official title: Effects of Intradialytic Cognitive and Physical Exercise Training on Functional Status of Hemodialysis Patients: Randomized Interventional Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Physical Inactivity
Chronic Kidney Diseases
Keywords: cognitive functions
hemodialysis
physical activity
intradialytic training
non-pharmacological interventions
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Test of Attentional Performance (TAP) score
timeFrame: baseline, after 12 weeks
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA) score
timeFrame: baseline, after 12 weeks
measure: Change in Trail Making Test A and B score
timeFrame: baseline, after 12 weeks
measure: Change in Symbol Digit Modalities Test (SDMT) score
timeFrame: baseline, after 12 weeks
measure: Change in 10 repetition sit-to-stand test time
timeFrame: baseline, after 12 weeks
measure: Change in Stork balance test time
timeFrame: baseline, after 12 weeks
measure: Change in frailty score
timeFrame: baseline, after 12 weeks
measure: Change in timed-up-and go (TUG) test time
timeFrame: baseline, after 12 weeks
measure: Change in handgrip strength (HGS) test
timeFrame: baseline, after 12 weeks
measure: Change in Kidney Disease Quality of Life Short Form (KDQoL-SF) score
timeFrame: baseline, after 12 weeks
measure: Change in spontaneous gait speed
timeFrame: baseline, after 12 weeks
measure: Change in Brain-derived neurotrophic factor (BDNF) concentration
timeFrame: baseline, after 12 weeks
measure: Change in Interleukin-6 concentration
timeFrame: baseline, after 12 weeks
measure: Change in C-reactive protein (CRP) concentration
timeFrame: baseline, after 12 weeks
measure: Change in hemoglobin concentration
timeFrame: baseline, after 12 weeks
measure: Change in urea concentration
timeFrame: baseline, after 12 weeks
measure: Change in phosphate concentration
timeFrame: baseline, after 12 weeks
measure: Change in albumin concentration
timeFrame: baseline, after 12 weeks
measure: Change in fat tissue index
timeFrame: baseline, after 12 weeks
measure: Change in lean tissue index
timeFrame: baseline, after 12 weeks
measure: Change in mental fatigue
timeFrame: baseline, after 12 weeks
measure: Change in hematocrit concentration
timeFrame: baseline, after 12 weeks
measure: Change in creatinine concentration
timeFrame: baseline, after 12 weeks
measure: Change in sodium concentration
timeFrame: baseline, after 12 weeks
measure: Change in potassium concentration
timeFrame: baseline, after 12 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre
state: Osrednjeslovenska
Study officials:
affiliation: University Medical Centre Ljubljana
name: Jadranka Buturović Ponikvar, PhD
role: STUDY_CHAIR
References:
citation: 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.