Chronic Kidney Disease (Stages 4 and 5)Exprecoimp-CKDNCT07160959
Physical Exercise to Prevent Mild-cognitive Impairment in Patients With Kidney Disfunctions
A study testing Exercise in people with Chronic Kidney Disease (Stages 4 and 5) and Mild Cognitive Impairment (MCI), run by Biogem s.c.ar.l. at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5), Mild Cognitive Impairment (MCI)
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 1 Jan 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD at KDOQI stage 4-5
- concomitant MCI (MOCA - MMSE (17 < MoCA < 26) or (16 < MMSE < 24)
Who cannot join
- 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 locations and contacts
6 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 6 countries
France1 site
Assistance Publique - Hôpitaux de Paris (AP-HP), Division of Geriatry
Paris
Marion Pépin, +33699426061, marion.pepin@aphp.fr
Italy1 site
Biogem
Ariano Irpino, 83031
Carminre Zoccali, +393407354062, carmine.zoccali@icloud.com
Ilaria Guerriero
Lithuania1 site
Lithuanian University of Health Sciences
Kaunas
Inga Bumblyte, +37037326189, ingabumblyte@gmail.com
Justina Kurganaite
Netherlands1 site
University Medical Center Groningen, Department of Nephrology
Groningen
Casper F.M. Franssen, +31631673051, c.f.m.franssen@umcg.nl
Manuela Ypes Calderon
Poland1 site
Medical University of Warsaw, Department of Nephrology, Dialysis and Internal Medicine
Warsaw
Jolanta Malyszko, +48225992660, jolmal@poczta.onet.pl
Alexandra Golenia
Switzerland1 site
University of Zurich
Zurich
Carsten A. Wagner, +41763770238, wagnerca@access.uzh.ch
About this study
Official title: Physical Exercise to Prevent Mild-cognitive Impairment Progression in Advanced Chronic Kidney Disease (CKD) and Dialysis Patients
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.
Read the 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.
- Being tested
- Exercise, Control (Standard treatment)
- Keywords
- Chronic Kidney Disease (CKD), stage G4-5 (CKD G4-5), dialysis, physical exercise, cognitive function
- Medical subject headings
- Renal Insufficiency, Chronic, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise
Control (Standard treatment)Other
Patients will be treated with standard therapy based on their CKD stage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Cognitive function using the Alzheimer Disease Assessment Scale Cognitive 11 (ADAS-Cog-11)
Measured: Baseline; End of program (6-month); Follow up (12-month; 24-month)
Secondary outcomes (9)
Magnetic Resonance Imaging (MRI)
Blood Oxygenation Level-Dependent (BOLD) Signal will be collected through functional MRI executed according to the published standards
Measured: Baseline and 6 months
6-minute walking test
The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters
Measured: Baseline; End of program (6-month); Follow up (12-month; 24-month)
Quality of life assessment
Quality of life will be assessed by the short-form 36 (SF-36) questionnaire This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks
Measured: Baseline; end of the program (6-month); Follow up (12-month; 24-month)
Lower limbs strength assessment
Lower limbs strength assessed by the 5-time sit-to-stand test Patients will raise up from a standard height chair with their arms folded across the chest five times as quickly as possible. The total time elapsed for completing the five repetitions is recorded in seconds
Measured: Baseline; end of the program (6-month); Follow up (12-month; 24-month)
Handgrip strength
Handgrip strength will be measured by a standard dynamometer. Peak value in kg for both arms will be collected
Measured: Baseline; End of program (6-month); Follow up (12-month; 24-month)
Body mass index assessment
Body mass index Body composition will be assessed with direct measures of height and weight. Body mass index will be calculated as the ratio between weight (in kg) and the squared height (in meters)
Measured: Baseline, end of the program (6-month); follow up (12-month; 24-month)
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by the CTCAE version 4.0
Measured: End of treatment (6-month)
Long-term survival rate assessment
Long-term survival rate All-cause mortality of the enrolled patients will be checked from the regional's datasets. In case of positive findings, the days elapsed from enrollment to the event will be recorded for additional analyses, as well as the reasons and the diagnoses.
Measured: 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
Long-term hospitalizations All-cause hospitalization will be checked from the regional's datasets. In case of positive findings, the days elapsed from enrollment to the event will be recorded for additional analyses, as well as the reasons and the diagnoses.
Measured: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); Follow up (36-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogem s.c.ar.l.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160959
- Sponsor's protocol ID
- ERA4HEALTHNUTRIBRAIN-086
- Other IDs
- ERA4HEALTH2024-NUTRIBRAIN
- Acronym
- Exprecoimp-CKD
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data will be shared with investigators who will make a request to the Principal investigator immediately after the publication of the main study results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise to Prevent Mild-cognitive Impairment Progression in Advanced Chronic Kidney Disease (CKD) and Dialysis Patients
- ClinicalTrials.gov ID
- NCT07160959
- Acronym / sponsor ID
- Exprecoimp-CKD / ERA4HEALTHNUTRIBRAIN-086
- Keywords
- Chronic Kidney Disease (CKD), stage G4-5 (CKD G4-5), dialysis, physical exercise, cognitive function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Biogem s.c.ar.l.University, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: ExerciseCombined 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 |
| Placebo comparator | Placebo comparator | Other: Control (Standard treatment)The control group will undergo standard nephrology care that include optimization of medical therapy, nutritional advices, best dialysis practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD at KDOQI stage 4-5
- concomitant MCI (MOCA - MMSE (17 < MoCA < 26) or (16 < MMSE < 24)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePatients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise | Behavioural | Experimental Arm |
| Control (Standard treatment)Patients will be treated with standard therapy based on their CKD stage | Other | Placebo comparator |
Primary outcome
Cognitive function
Time frame: Baseline; End of program (6-month); Follow up (12-month; 24-month)
Cognitive function using the Alzheimer Disease Assessment Scale Cognitive 11 (ADAS-Cog-11)
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data will be shared with investigators who will make a request to the Principal investigator immediately after the publication of the main study results.
Related trials for Chronic Kidney Disease (Stages 4 and 5)
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
Not yet recruiting
Feasibility of the COMFORT (COmplex Symptom Management Intervention FOR adulTs With Advanced Kidney Disease) Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers
Chronic Kidney Disease (Stages 4 and 5)
Not yet recruiting
Inspiratory Muscle Training During Hemodialysis
Chronic Kidney Disease (Stages 4 and 5), Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Kidney Disease (Stages 4 and 5) and Mild Cognitive Impairment (MCI), run by Biogem s.c.ar.l. at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Italy, Lithuania, Netherlands, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crmine Zoccali (+393407354062, carmine.zoccali@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Baseline; End of program (6-month); Follow up (12-month; 24-month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.