Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease

Effects of Bioelectric Stimulation on Kidney Function and Sarcopenia in Patients With Non-Dialysis Dependent Chronic Kidney Disease (CKD): Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Insufficiency, Chronic; Electric Stimulation
• Intervention / Treatment: Device: Bioelectric stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo DM Plentz, PhD; Phone Number: +55 51 3303-8700; Email: roplentz@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bioelectric stimulation; Bioelectric stimulation on quadriceps muscle and kidneys: 45 minutes, 3 times/week, 8 weeks, 24 sessions.	Device: Bioelectric stimulation; The sessions will include 20 minutes for stimulation of the thigh muscles and 45 minutes for stimulation of the kidneys. The electrodes will be placed on the motor point of the quadriceps muscle in both lower limbs. The neuromuscular electric stimulation will be applied by symmetrical biphasic pulsed current, at an 80 Hz frequency, 400 ms pulse width, 10 s contraction time, rest time decreasing as the protocol advanced, at reciprocal mode. The intensity will be individually adjusted to produce visible muscle contraction. Concomitant, two electrodes will be placed in the abdominal corresponding to the kidney anatomical site and two electrodes on the dorsal region at the level of the 10th thoracic vertebra. The stimulation of the kidneys will include in addition to Klotho, precise signals for several pro-regenerative proteins. The intensity of the electric current will be individually adjusted to sensory stimulation.
NO_INTERVENTION: Control; No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from kidney function	The kidney function will be assessed through the blood collection and dosage of serum creatinine	Baseline, after 4 weeks and after 8 weeks
Change from kidney function	The kidney function will be assessed through the blood collection and dosage of α-klotho protein expression	Baseline, after 4 weeks and after 8 weeks
Change from kidney function	The kidney function will be assessed through the glomerular filtration rate	Baseline, after 4 weeks and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional capacity	Functional capacity will be assessed by change in distance covered in the six minute walk test	Baseline and after 8 weeks
Change in muscle strength	Muscle strength will be evaluated by dynamometry by a load cell	Baseline and after 8 weeks
Change in muscle strength of the lower limbs	Muscle strength of the lower limbs will be assessed by sit-and-stand test of 10 repetitions	Baseline and after 8 weeks
Change in quality of life evaluation	The quality of life will be assessed by questionnaire EuroQol-5D health questionnaire	Baseline and after 8 weeks
Adverse effects	Adverse effects will be recorded in number of cases and type of event	After 8 weeks
Change in inflammatory profile	The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 6	Baseline, after 4 weeks and after 8 weeks
Change in inflammatory profile	The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 10	Baseline, after 4 weeks and after 8 weeks
Change in inflammatory profile	The inflammatory profile will be assessed through the blood collection and analysis of immunological marker tumor necrosis factor	Baseline, after 4 weeks and after 8 weeks

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 25, 2021
• Primary Completion (ANTICIPATED): June 25, 2022
• Study Completion (ANTICIPATED): October 25, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (ACTUAL): November 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: CKD_EE_Klotho

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No