Physical Exercise to Prevent Mild-cognitive Impairment in Patients With Kidney Disfunctions
NCT ID: NCT07160959
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
124 participants
INTERVENTIONAL
2026-01-01
2030-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental Arm
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
Exercise
Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise
Placebo comparator
The control group will undergo standard nephrology care that include optimization of medical therapy, nutritional advices, best dialysis practice.
Control (Standard treatment)
Patients will be treated with standard therapy based on their CKD stage
Interventions
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Exercise
Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise
Control (Standard treatment)
Patients will be treated with standard therapy based on their CKD stage
Eligibility Criteria
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Inclusion Criteria
* concomitant MCI (MOCA - MMSE (17 \< MoCA \< 26) or (16 \< MMSE \< 24)
Exclusion Criteria
* Known life expectancy \< 6-month
* Uncorrected anemia (Hb \<9 g/dl)
* Non-provision of informed consent
18 Years
ALL
No
Sponsors
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Biogem s.c.ar.l.
OTHER
Responsible Party
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Locations
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Assistance Publique - Hôpitaux de Paris (AP-HP), Division of Geriatry
Paris, , France
Biogem
Ariano Irpino, , Italy
Lithuanian University of Health Sciences
Kaunas, , Lithuania
University Medical Center Groningen, Department of Nephrology
Groningen, , Netherlands
Medical University of Warsaw, Department of Nephrology, Dialysis and Internal Medicine
Warsaw, , Poland
University of Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ERA4HEALTH2024-NUTRIBRAIN
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ERA4HEALTHNUTRIBRAIN-086
Identifier Type: -
Identifier Source: org_study_id
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