Physical Exercise to Prevent Mild-cognitive Impairment in Patients With Kidney Disfunctions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Control (Standard treatment).
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease (Stages 4 and 5), Mild Cognitive Impairment (MCI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy, Lithuania, Netherlands, Poland +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Physical Exercise to Prevent Mild-cognitive Impairment Progression in Advanced Chronic Kidney Disease (CKD) and Dialysis Patients
Overview
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.
Interventions
- Behavioral Exercise
Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise - Other Control (Standard treatment)
Patients will be treated with standard therapy based on their CKD stage
Primary outcome measures
- Cognitive function [Time frame: Baseline; End of program (6-month); Follow up (12-month; 24-month)]
Secondary outcome measures (9)
- Magnetic Resonance Imaging (MRI) [Time frame: Baseline and 6 months]
- 6-minute walking test [Time frame: Baseline; End of program (6-month); Follow up (12-month; 24-month)]
- Quality of life assessment [Time frame: Baseline; end of the program (6-month); Follow up (12-month; 24-month)]
- Lower limbs strength assessment [Time frame: Baseline; end of the program (6-month); Follow up (12-month; 24-month)]
- Handgrip strength [Time frame: Baseline; End of program (6-month); Follow up (12-month; 24-month)]
- Body mass index assessment [Time frame: Baseline, end of the program (6-month); follow up (12-month; 24-month)]
- Safety and tolerability [Time frame: End of treatment (6-month)]
- Long-term survival rate assessment [Time frame: 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 [Time frame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); Follow up (36-month)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Assistance Publique - Hôpitaux de Paris (AP-HP), Division of Geriatry — Paris
Italy · 1 center
- Biogem — Ariano Irpino
Lithuania · 1 center
- Lithuanian University of Health Sciences — Kaunas
Netherlands · 1 center
- University Medical Center Groningen, Department of Nephrology — Groningen
Poland · 1 center
- Medical University of Warsaw, Department of Nephrology, Dialysis and Internal Medicine — Warsaw
Switzerland · 1 center
- University of Zurich — Zurich
Identifiers
NCT: NCT07160959 · ERA4HEALTHNUTRIBRAIN-086 · ERA4HEALTH2024-NUTRIBRAIN