Protein and Exercise Training in Chronic KIDNEY Disease (NCT05482243) | Clinical Trial Compass
CompletedNot Applicable
Protein and Exercise Training in Chronic KIDNEY Disease
Netherlands40 participantsStarted 2023-01-01
Plain-language summary
When patients progress to the final stage of chronic kidney disease (CKD) and require hemodialysis treatment, they typically have lost so much muscle function that they are no longer physically independent. However, due to disease- and hemodialysis-related muscle catabolism, dietary protein and exercise interventions are only capable to attenuate the decline in physical function of patients on hemodialysis treatment. Therefore, lifestyle interventions to increase muscle function should be implemented before hemodialysis is required. However, it is still a matter of debate whether muscle protein synthesis rates of patients with advanced CKD can be increased with a patient-tailored dietary protein and exercise intervention.Therefore, the current study will assess MPS rates during habitual lifestyle and during an interventional program including dietary protein and exercise in patients with advanced CKD. In addition, we will compare MPS rates during free-living conditions between patients with advanced CKD and healthy controls.
Who can participate
Age range
18 Years – 80 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.
1. In order to be eligible to participate in this study, a patient with CKD must meet all of the following criteria:
* (e)glomerular filtration rate (GFR) \<45 ml/min/1.73m2
* Age: 18 - 80 y
* Able to provide written informed consent
2. In order to be eligible to participate in this study, a healthy subject must meet all of the following criteria:
* (e)GFR \>60 ml/min/1.73m2 without albuminuria
* Age: 18 - 80 y
* Able to provide written informed consent
1\. A potential subject with CKD who meets any of the following criteria will be excluded from participation in this study:
* Insulin-dependent diabetes mellitus or two or more oral glucose lowering medications
* Active inflammatory disease / malignancies
* Uncontrolled hypertension (\>160/100mm Hg), unstable angina pectoris, or arrhythmia
* Pulmonary disease restricting exercise performance (e.g. COPD)
* A history of neuromuscular problems
* Cognitive Impairment
* Diagnosed GI tract diseases / dysphagia
* Allergies to milk proteins / Lactose intolerance
* Pregnancy
* Hospitalization \<1 months prior to study period
* Participation in any structured exercise program
* Any medications known to affect protein metabolism (i.e. corticosteroids or prescription strength acne medications).
* Use of DOAC, vitamin-K-antagonist, or multiple anticoagulants.
* Dialysis treatment or previous kidney transplantation
2\. A potential healthy subject who meets any of the following criteria will be excluded from particip…
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.