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

NCT07160959 | Not Yet Recruiting DMC

• 2 other identifiers: ERA4HEALTHNUTRIBRAIN-086ERA4HEALTH2024-NUTRIBRAIN
• Study Type: interventional
• Target: 124
• Locations: 6 countries
• Sites: 6

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.

Conditions

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

Keywords

Chronic Kidney Disease (CKD); stage G4-5 (CKD G4-5); dialysis; physical exercise; cognitive function

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  Cognitive function using the Alzheimer Disease Assessment Scale Cognitive 11 (ADAS-Cog-11)

  Baseline; End of program (6-month); Follow up (12-month; 24-month)

Secondary Outcomes (9)

• Magnetic Resonance Imaging (MRI)

  Baseline and 6 months

• 6-minute walking test

  Baseline; End of program (6-month); Follow up (12-month; 24-month)

• Quality of life assessment

  Baseline; end of the program (6-month); Follow up (12-month; 24-month)

• Lower limbs strength assessment

  Baseline; end of the program (6-month); Follow up (12-month; 24-month)

• Handgrip strength

  Baseline; End of program (6-month); Follow up (12-month; 24-month)

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Combined aerobic (walking) and resistance exercise group. Patients randomised to this group will receive a structured exercise program to be performed at least thrice a week for 26 weeks. The physical exercise intervention will be managed and supervised by the personnel of the centres participating in the trial. The training program will be personalised according to the patient's baseline functional capacity assessed by the 6-minute walking test (6MWT). The aerobic exercise will include seven bouts of 2-minute walking separated by 1-minute seated rest (up to 2-minute periods of resting in the Very Low category) at a slow to moderate speed. A smartphone application designed to guide the weekly increase in speed will also record the number of training sessions performed. An instructor will specifically instruct all patients to walk in rhythm with the metronome. The goal intensity for each session is 9-10 (light-fairly light) on the 20-point Borg RPE. The number of steps per session will

Behavioral: Exercise

Placebo comparator

PLACEBO COMPARATOR

The control group will undergo standard nephrology care that include optimization of medical therapy, nutritional advices, best dialysis practice.

Other: Control (Standard treatment)

Interventions

Exercise BEHAVIORAL

Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise

Experimental Arm

Control (Standard treatment) OTHER

Patients will be treated with standard therapy based on their CKD stage

Placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogem s.c.ar.l.: lead

Study Sites (6)

Assistance Publique - Hôpitaux de Paris (AP-HP), Division of Geriatry

Paris, France

Location

Biogem

Ariano Irpino, 83031, Italy

Location

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

University Medical Center Groningen, Department of Nephrology

Groningen, Netherlands

Location

Medical University of Warsaw, Department of Nephrology, Dialysis and Internal Medicine

Warsaw, Poland

Location

University of Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cognitive Dysfunction; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Crmine Zoccali

CONTACT

+393407354062; carmine.zoccali@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: after the publication of the main study results
• Access Criteria: Scientists will be able to access supporting in formation, they will access the study protocol and the results.

Locations

CH (1); NL (1); IT (1); FR (1); PL (1); LI (1)