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

NCT ID: NCT05124756

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2022-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Insufficiency, Chronic Electric Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bioelectric stimulation

Bioelectric stimulation on quadriceps muscle and kidneys: 45 minutes, 3 times/week, 8 weeks, 24 sessions.

Group Type EXPERIMENTAL

Bioelectric stimulation

Intervention Type DEVICE

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.

Control

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leonhardt Ventures LLC

INDUSTRY

Sponsor Role collaborator

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Della Méa Plentz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo DM Plentz, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Sciences of Porto Alegre

Central Contacts

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Rodrigo DM Plentz, PhD

Role: CONTACT

Phone: +55 51 3303-8700

Email: [email protected]

Other Identifiers

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CKD_EE_Klotho

Identifier Type: -

Identifier Source: org_study_id