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

NCT05124756 | Unknown DMC

• 1 other identifier: CKD_EE_Klotho
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Insufficiency, Chronic; Electric Stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change in functional capacity

  Baseline and after 8 weeks

• Change in muscle strength

  Baseline and after 8 weeks

• Change in muscle strength of the lower limbs

  Baseline and after 8 weeks

• Change in quality of life evaluation

  Baseline and after 8 weeks

• Adverse effects

  After 8 weeks

Study Arms (2)

Bioelectric stimulation

EXPERIMENTAL

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

Device: Bioelectric stimulation

Control

NO INTERVENTION

No intervention.

Interventions

Bioelectric stimulation 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.

Bioelectric stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Leonhardt Ventures LLC: collaborator
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo DM Plentz, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo DM Plentz, PhD

CONTACT

+55 51 3303-8700; roplentz@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 18, 2021
• Study Start: November 25, 2021
• Primary Completion: June 25, 2022
• Study Completion: October 25, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share