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
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
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.
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
NCT ID
NCT05124756
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
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
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Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease
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