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ClinicalTrials.gov ID

NCT07160959

Lead Sponsor

Biogem s.c.ar.l.OTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

124Estimated

Last Update Posted

Sep 8, 2025Actual

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Apr 30, 2028Estimated

Completion Date

Apr 30, 2030Estimated

Official Title

Physical Exercise to Prevent Mild-cognitive Impairment Progression in Advanced Chronic Kidney Disease (CKD) and Dialysis Patients

Brief Summary

This research project focuses on improving memory and thinking (cognitive function) in people with advanced chronic kidney disease (CKD), a condition that affects about 10% of adults and is often linked to cognitive problems. The study includes a clinical trial where patients will either receive standard care or follow a home-based exercise program involving walking and strength training, to see if regular physical activity can improve brain function. It also includes a large-scale analysis of data from the UK Biobank to explore blood and genetic markers, brain imaging, and lifestyle factors linked to cognitive health. The ultimate aim is to find effective, easy-to-implement strategies and early warning signs that could lead to better treatment and quality of life for people living with CKD.

Detailed Description

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.

• Chronic Kidney Disease (Stages 4 and 5)
• Mild Cognitive Impairment (MCI)

• Exercise
• Control (Standard treatment)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• CKD at KDOQI stage 4-5
• concomitant MCI (MOCA - MMSE (17 < MoCA < 26) or (16 < MMSE < 24)

Exclusion Criteria:

• Absolute contraindication to exercise training (e.g. unstable angina, major amputation, severe heart failure, etc.)
• Known life expectancy < 6-month
• Uncorrected anemia (Hb <9 g/dl)
• Non-provision of informed consent

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Biogem s.c.ar.l.OTHER

carmine.zoccali@icloud.com+393407354062

ingabumblyte@gmail.com+37037326189

wagnerca@access.uzh.ch+41763770238