Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease (NCT04330807) | Clinical Trial Compass
UnknownNot Applicable
Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
France220 participantsStarted 2020-06-22
Plain-language summary
Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. Muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue.
The present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced CKD, through a maximal voluntary contraction (MVC) handgrip test compared to control data available in the literature, matched in term of age and sex. It also aims to investigate the link between the reported fatigue (subjective) and the evolution of the MVC, called critical force (fcrit) during a fatiguing task (objective fatigability).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults, aged 60 and over
* Social security coverage
* Signed informed consent
* For patient with Chronic Kidney Disease, estimated glomerular filtration rate (eGFR) less than 45ml/min/1.73m2 (Stage 3b) for at least 3 months
* For patient with Chronic Kidney Disease, stable clinical condition (i.e., Creatinine increased by a maximum of 25% in the previous 3 months)
* For control group, 1:1 recruitment with case matching with CDK patients on gender (i.e., male and female) and the presence of diabètes (i.e., presence and absence)
* For control group, blood test with control of renal function available and dated less than 6 months: with eGFR \> 60ml/min/1.73m2 (and control of glucose or glycated hemoglobin for diabetic controls)
Exclusion Criteria:
* Pregnant women
* Under guardianship or minor
* Neuromuscular disease
* Dementia
* Upper limbs history of surgery or pathologies preventing from fitting EMG electrodes or measuring handgrip force
* Life expectancy of less than 3 months estimated by medical judgment
* Programed hospitalization in the previous 3 months
* Participation to another interventional clinical trial
* Acute kidney disease
* On dialysis or expected start of dialysis within next 3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.