Physical Exercise to Prevent Mild-cognitive Impairment in Patients With Kidney Disfunctions (Exprecoimp-CKD)

Biogem s.c.ar.l.

Status: Not yet enrolling

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

Treatments: Other: Control (Standard treatment); Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07160959

ERA4HEALTH2024-NUTRIBRAIN (Other Grant/Funding Number)

ERA4HEALTHNUTRIBRAIN-086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups, including a placebo group

Experimental Arm

Experimental group

Description:

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

Treatment:

Behavioral: Exercise

Placebo comparator

Placebo Comparator group

Description:

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

Treatment:

Other: Control (Standard treatment)