Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease (NCT05124756) | Clinical Trial Compass
UnknownNot Applicable
Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease
30 participantsStarted 2021-11-25
Plain-language summary
Chronic kidney disease (CKD) consists of kidney damage, with a consequent progressive and irreversible loss of kidney function. In the early stages of the disease, there is already a reduction in circulating levels of α-klotho protein, which is related to worsening renal function. Therapeutic strategies that increase serum α-klotho levels can be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the efficiency rate of dialysis, suggesting a systemic effect in patients with end-stage CKD. The aim of this study is to evaluate the effects of bioelectric stimulation on renal function and physical capacity in patients with CKD. For this, patients will be randomized into bioelectric stimulation or a control group. Bioelectric stimulation will be performed three times a week for eight weeks. The control group will only be evaluated and re-evaluated. The following pre-and post-intervention assessments will be performed: analysis of the plasma content of α-Klotho and soluble creatinine to assess renal function, six-minute walk test to assess functional capacity; dosage of interleukins and tumor necrosis factor to analyze the inflammatory profile; sit and stand test with 10 repetitions and load cell dynamometry to assess lower limb muscle strength and application of the EuroQoL-5D questionnaire for quality of life. Biochemical analyzes for renal function and inflammatory profile will also be performed after four weeks of follow-up.
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.
Inclusion Criteria:
* Age 18-80 years of age;
* CKD with glomerular filtration rate (GFR) between 15-59 ml/min (III and IV stage of CKD) for more than 3 months;
* To be able to ambulate \> 300 meters in 6 minutes walk test.
Exclusion Criteria:
* Cognitive dysfunction that prevents the performance of evaluations, as well as an inability to understand and sign the informed consent form;
* Intolerance to the electrostimulator and/or alteration of skin sensitivity;
* Skin lesions/burns at the electrode placement site;
* Patients with stroke in past 6 months with residual limitation to ambulation;
* Disabling musculoskeletal disease;
* Uncontrolled hypertension (systolic blood pressure \> 230 mmHg and diastolic blood pressure \> 120 mmHg);
* Grade III or IV heart failure (NYHA);
* Patient with a pacemaker;
* Uncontrolled diabetes (fasting blood glucose \> 250 mg/dL);
* Unstable angina;
* Coronary stent placement in past 3 months;
* Recent acute myocardial infarction (two months);
* Fever and/or infectious disease;
* Peripheral vascular disease in the lower limbs that limits ambulation or deep vein thrombosis;
* Chronic obstructive lung disease that limits ambulation or need for oxygen therapy;
* Obesity (Body Mass Index≥35);
* Patient with active cancer.
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.
What they're measuring
1
Change from kidney function
Timeframe: Baseline, after 4 weeks and after 8 weeks
2
Change from kidney function
Timeframe: Baseline, after 4 weeks and after 8 weeks
3
Change from kidney function
Timeframe: Baseline, after 4 weeks and after 8 weeks
Trial details
NCT IDNCT05124756
SponsorFederal University of Health Science of Porto Alegre