Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ERA4HEALTH2024-NUTRIBRAIN | Other Grant/Funding Number | ERA4HEALTH Partnership |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo comparator | Placebo Comparator | The control group will undergo standard nephrology care that include optimization of medical therapy, nutritional advices, best dialysis practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Cognitive function using the Alzheimer Disease Assessment Scale Cognitive 11 (ADAS-Cog-11) | Baseline; End of program (6-month); Follow up (12-month; 24-month) |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Blood Oxygenation Level-Dependent (BOLD) Signal will be collected through functional MRI executed according to the published standards | Baseline and 6 months |
| 6-minute walking test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crmine Zoccali | Contact | +393407354062 | carmine.zoccali@icloud.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris (AP-HP), Division of Geriatry | Paris | France |
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.
Not provided
after the publication of the main study results
Scientists will be able to access supporting in formation, they will access the study protocol and the results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control (Standard treatment) | Other | Patients will be treated with standard therapy based on their CKD stage |
|
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
| 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 | 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 | 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 | 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) | 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 | 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. | 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. | Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); Follow up (36-month) |
| Biogem | Ariano Irpino | 83031 | 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 |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided