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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Medical Centre
Ljubljana, Osrednjeslovenska, Slovenia
Start Date
November 2, 2022
Primary Completion Date
January 25, 2023
Completion Date
June 30, 2023
Last Updated
February 14, 2024
44
ACTUAL participants
Cognitive and physical exercise training
OTHER
Lead Sponsor
University Medical Centre Ljubljana
NCT04592640
NCT07438808
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