Health TrialsbyHealthPanel

Physical Exercise to Prevent Mild-cognitive Impairment in Patients With Kidney Disfunctions

ConditionsChronic Kidney Disease (Stages 4 and 5)Mild Cognitive Impairment (MCI)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiogem s.c.ar.l.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CKD at KDOQI stage 4-5

concomitant MCI (MOCA - MMSE (17 < MoCA < 26) or (16 < MMSE < 24)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Behavioral

    Patients will undergo a home-based low-intensity interval multi component exercise program including aerobic and strengthening exercise

  • Control (Standard treatment)

    Other intervention

    Patients will be treated with standard therapy based on their CKD stage

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Placebo comparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive function

Cognitive function using the Alzheimer Disease Assessment Scale Cognitive 11 (ADAS-Cog-11)

Time frame
Baseline; End of program (6-month); Follow up (12-month; 24-month)

Secondary outcomes

1

Magnetic Resonance Imaging (MRI)

Blood Oxygenation Level-Dependent (BOLD) Signal will be collected through functional MRI executed according to the published standards

Time frame
Baseline and 6 months
2

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

Time frame
Baseline; End of program (6-month); Follow up (12-month; 24-month)
3

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

Time frame
Baseline; end of the program (6-month); Follow up (12-month; 24-month)
4

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

Time frame
Baseline; end of the program (6-month); Follow up (12-month; 24-month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biogem s.c.ar.l.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: