Physical Exercise to Prevent Mild-cognitive Impairment in Patients With Kidney Disfunctions

The project aims to test the impact of exercise programs on cognitive function in stage G 4-5 CKD and dialysis patients with MCI in a randomised clinical trial. A structured physical exercise program (walking exercise) effectively improved physical performance and quality of life in dialysis patients in a previous trial by us (see reference 6 by the investigators of this proposal). We will combine resistance and walking exercise in the active arm of the trial. In parallel with this trial, the project aims to test the cross-sectional and longitudinal relationship between physical activity (PAA) and the genetic and circulatory biomarkers of cognitive function and brain MRI in CKD patients and individuals without CKD in the UK Biobank.

Randomised clinical trial This trial will test a structured combined physical exercise program based on home-based aerobic (walking) exercise and resistance exercise maintained for 26 weeks on cognitive function in predialysis patients with advanced CKD (stages 4-5) and dialysis patients with MCI compared to the usual care (control group). In the two study arms, nutritional guidelines by KDIGO will be implemented, and nutrient intake will be periodically assessed. For this purpose, an App for CKD patients, including dietary advice and registering nutrients, will be adapted to the languages of centres in participating countries. Furthermore, body composition will be assessed during the study visits using validated bio-impedance spectroscopy instruments. Two-thirds of enrolees will be predialysis CKD patients and one-third dialysis patients (haemodialysis or peritoneal dialysis patients). Partners or caregivers to assist patients in the trial's exercise arm are requested explicitly for inclusion.

• Magnetic Resonance Imaging (MRI) [Срок оценки: Baseline and 6 months]
• 6-minute walking test [Срок оценки: Baseline; End of program (6-month); Follow up (12-month; 24-month)]
• Quality of life assessment [Срок оценки: Baseline; end of the program (6-month); Follow up (12-month; 24-month)]
• Lower limbs strength assessment [Срок оценки: Baseline; end of the program (6-month); Follow up (12-month; 24-month)]
• Handgrip strength [Срок оценки: Baseline; End of program (6-month); Follow up (12-month; 24-month)]
• Body mass index assessment [Срок оценки: Baseline, end of the program (6-month); follow up (12-month; 24-month)]
• Safety and tolerability [Срок оценки: End of treatment (6-month)]
• Long-term survival rate assessment [Срок оценки: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); Follow up (36-month)]
• Long-term hospitalizations assessment [Срок оценки: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); Follow up (36-month)]