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

Primary Purpose

Renal Insufficiency, Chronic, Electric Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bioelectric stimulation
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Bioelectric stimulation

    Control

    Arm Description

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

    No intervention.

    Outcomes

    Primary Outcome Measures

    Change from kidney function
    The kidney function will be assessed through the blood collection and dosage of serum creatinine
    Change from kidney function
    The kidney function will be assessed through the blood collection and dosage of α-klotho protein expression
    Change from kidney function
    The kidney function will be assessed through the glomerular filtration rate

    Secondary Outcome Measures

    Change in functional capacity
    Functional capacity will be assessed by change in distance covered in the six minute walk test
    Change in muscle strength
    Muscle strength will be evaluated by dynamometry by a load cell
    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
    Change in quality of life evaluation
    The quality of life will be assessed by questionnaire EuroQol-5D health questionnaire
    Adverse effects
    Adverse effects will be recorded in number of cases and type of event
    Change in inflammatory profile
    The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 6
    Change in inflammatory profile
    The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 10
    Change in inflammatory profile
    The inflammatory profile will be assessed through the blood collection and analysis of immunological marker tumor necrosis factor

    Full Information

    First Posted
    October 15, 2021
    Last Updated
    November 7, 2021
    Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Leonhardt Ventures LLC, Irmandade Santa Casa de Misericórdia de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05124756
    Brief Title
    Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease
    Official Title
    Effects of Bioelectric Stimulation on Kidney Function and Sarcopenia in Patients With Non-Dialysis Dependent Chronic Kidney Disease (CKD): Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 25, 2021 (Anticipated)
    Primary Completion Date
    June 25, 2022 (Anticipated)
    Study Completion Date
    October 25, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre
    Collaborators
    Leonhardt Ventures LLC, Irmandade Santa Casa de Misericórdia de Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency, Chronic, Electric Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bioelectric stimulation
    Arm Type
    Experimental
    Arm Description
    Bioelectric stimulation on quadriceps muscle and kidneys: 45 minutes, 3 times/week, 8 weeks, 24 sessions.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No intervention.
    Intervention Type
    Device
    Intervention Name(s)
    Bioelectric stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from kidney function
    Description
    The kidney function will be assessed through the blood collection and dosage of serum creatinine
    Time Frame
    Baseline, after 4 weeks and after 8 weeks
    Title
    Change from kidney function
    Description
    The kidney function will be assessed through the blood collection and dosage of α-klotho protein expression
    Time Frame
    Baseline, after 4 weeks and after 8 weeks
    Title
    Change from kidney function
    Description
    The kidney function will be assessed through the glomerular filtration rate
    Time Frame
    Baseline, after 4 weeks and after 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in functional capacity
    Description
    Functional capacity will be assessed by change in distance covered in the six minute walk test
    Time Frame
    Baseline and after 8 weeks
    Title
    Change in muscle strength
    Description
    Muscle strength will be evaluated by dynamometry by a load cell
    Time Frame
    Baseline and after 8 weeks
    Title
    Change in muscle strength of the lower limbs
    Description
    Muscle strength of the lower limbs will be assessed by sit-and-stand test of 10 repetitions
    Time Frame
    Baseline and after 8 weeks
    Title
    Change in quality of life evaluation
    Description
    The quality of life will be assessed by questionnaire EuroQol-5D health questionnaire
    Time Frame
    Baseline and after 8 weeks
    Title
    Adverse effects
    Description
    Adverse effects will be recorded in number of cases and type of event
    Time Frame
    After 8 weeks
    Title
    Change in inflammatory profile
    Description
    The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 6
    Time Frame
    Baseline, after 4 weeks and after 8 weeks
    Title
    Change in inflammatory profile
    Description
    The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 10
    Time Frame
    Baseline, after 4 weeks and after 8 weeks
    Title
    Change in inflammatory profile
    Description
    The inflammatory profile will be assessed through the blood collection and analysis of immunological marker tumor necrosis factor
    Time Frame
    Baseline, after 4 weeks and after 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rodrigo DM Plentz, PhD
    Phone
    +55 51 3303-8700
    Email
    roplentz@yahoo.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodrigo DM Plentz, PhD
    Organizational Affiliation
    Federal University of Health Sciences of Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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