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

November 7, 2021 updated by: Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from kidney function
Time Frame: Baseline, after 4 weeks and after 8 weeks
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
Time Frame: Baseline, after 4 weeks and after 8 weeks
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
Time Frame: Baseline, after 4 weeks and after 8 weeks
The kidney function will be assessed through the glomerular filtration rate
Baseline, after 4 weeks and after 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in functional capacity
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
Muscle strength will be evaluated by dynamometry by a load cell
Baseline and after 8 weeks
Change in muscle strength of the lower limbs
Time Frame: Baseline and after 8 weeks
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
Time Frame: Baseline and after 8 weeks
The quality of life will be assessed by questionnaire EuroQol-5D health questionnaire
Baseline and after 8 weeks
Adverse effects
Time Frame: After 8 weeks
Adverse effects will be recorded in number of cases and type of event
After 8 weeks
Change in inflammatory profile
Time Frame: Baseline, after 4 weeks and after 8 weeks
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
Time Frame: Baseline, after 4 weeks and after 8 weeks
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
Time Frame: Baseline, after 4 weeks and after 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Irmandade Santa Casa de Misericórdia de Porto Alegre
Leonhardt Ventures LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings