About this trial
Chronic kidney disease (CKD) consists of kidney damage, with consequent progressive and irreversible loss of kidney function. In the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, which is related to worsening renal function. Therapeutic strategies that increase serum levels of α-klotho may be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the effectiveness rate of dialysis, suggesting a systemic effect in patients with terminal CKD. The objective of this study is to evaluate the effects of whole body electrical stimulation on renal function and physical capacity in patients with CKD not dependent on dialysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with CKD (≥ 3 months) in stages 3-4 (GFR between 59 and 15 ml/min/1.73m2);
Age between 18 and 80 years old;
Functional capacity ≥ 300 meters in the six-minute walk test.
Disqualifiers
Cognitive dysfunction that prevents assessments from being carried out or inability to understand and sign the informed consent form;
Intolerance to electrical stimulator and/or changes in skin sensitivity;
Skin injuries or burns where the electrodes are positioned;
Patients with stroke sequelae;
Trial design
Parallel
Treatments tested in this trial
Whole-body electrical stimulation
Other interventionSymmetrical biphasic current, pulse width of 400 μs, frequency of 75 Hz, contraction time of five seconds and rest time of 10 seconds. The intensity will be individually adjusted to the patient's maximum tolerance limit to reach the motor threshold and the volunteer will be instructed to achieve a score of 7 on the modified BORG scale to ensure a moderate-intense effort. The session time will be 16 minutes, resulting in a total of 64 contractions per session. The progression of overload will only occur with an increase in the intensity of all muscle groups during the sessions. Concomitantly with the electrical stimuli, the volunteer will perform exercises for the upper, lower limbs and trunk. After performing neuromuscular electrical stimulation, the patient will remain in the supine position to receive sensory stimulation throughout the body. The parameters used will be: frequency of 20 Hz and pulse width of 400 μs for 44 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Change in kidney function
Change in kidney function will be assessed by alpha klotho protein dosage
Change in kidney function
Change in kidney function will be assessed by serum creatinine measurement
Secondary outcomes
Change in inflammatory profile
Change in inflammatory profile will be assessed by measurement of interleukin 6 (IL6)
Change in inflammatory profile
Change in inflammatory profile will be assessed by measurement of interleukin 10 (IL10)
Change in inflammatory profile
Change in inflammatory profile will be assessed by measurement of tumor necrosis factor alpha (TNF-a)
Change in well-being levels
Change in well-being levels will be assessed by serum beta-endorphin dosage
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Federal University of Health Science of Porto Alegre
Lead sponsor
Leonhardt Ventures LLC
Collaborator
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