Exercise to prevent mild cognitive problems from worsening in people with advanced chronic kidney disease and those undergoing dialysis.

Physical exercise to prevent mild-cognitive impairment progression in advanced chronic kidney disease (CKD) and dialysis patients. - Physical Exercise to prevent mild-cognitive impairment progression in advanced chronic kidney disease (CKD) and dialysis patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58390

Enrollment

Registered

2025-05-27

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease, Mild cognitive impairment Chronic kidney disease, Mild cognitive problems

Interventions

A 26-week personalized home-based physical exercise program based on aerobic exercise (walking) and resistance training. The control group will receive standard care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age =18 yearsCKD stage 4-5 or treated with either peritoneal dialysis or hemodialysisPatients with values below the threshold for the diagnosis of MCI but with values above the threshold for the diagnosis of dementia in the Mini Mental State Examination (MMSE) or the Montreal Cognitive Assessment (MoCA) [14,15]. The thresholds adjusted for age and education, as recommended by both instruments’ guidelines, will be >17 and < 26 for the MoCA, and >16 and <24 for the MMSE.

Exclusion criteria

Exclusion criteria: Absolute contraindication to exercise training (unstable angina, major amputation, severe heart failure).Life expectancy <6-months.Uncorrected anemia defined as hemoglobin <6 mmol/l (<9 g/dl).No caretaker that can assist with the intervention at home. Non-provision of informed consent.

Design outcomes

Primary

Measure	Time frame
The main outcome measure of the trial is change in cognitive function assessed by the Alzheimer Disease Assessment Scale Cognitive 11 (ADAS-Cog-11, tested at inclusion, 13, 26, 52 and 104 weeks). Significant improvements in either ADAS-Cog-11 at week 26 will be considered proof of efficacy.	—

Secondary

Measure	Time frame
Secondary outcome measures are changes in brain nuclear magnetic resonance (NMR) parameters potentially sensitive to an exercise-based intervention (tested at inclusion, 26 and 52 weeks). Other secondary outcomes are incidence of events (death, cardiovascular event, start of dialysis or transplantation), and changes in estimated Glomerular Filtration Rate (eGFR), quality of life, muscular capacity, body composition, nutritional assessment, physical activity, gut microbiome composition, and biomarkers of neuroplasticity, kidney function, cardiovascular capacity and inflammation (tested at inclusion, 13, 26, 52 and 104 weeks).	—

Measure

Time frame

Secondary outcome measures are changes in brain nuclear magnetic resonance (NMR) parameters potentially sensitive to an exercise-based intervention (tested at inclusion, 26 and 52 weeks). Other secondary outcomes are incidence of events (death, cardiovascular event, start of dialysis or transplantation), and changes in estimated Glomerular Filtration Rate (eGFR), quality of life, muscular capacity, body composition, nutritional assessment, physical activity, gut microbiome composition, and biomarkers of neuroplasticity, kidney function, cardiovascular capacity and inflammation (tested at inclusion, 13, 26, 52 and 104 weeks).

—

Countries

France, Italy, Lithuania, Netherlands, Poland, Switzerland

Contacts

Public ContactC.F.M. Franssen

Universitair Medisch Centrum Groningen

c.f.m.franssen@umcg.nl050-3615497

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026