Renal Insufficiency, ChronicNCT05124756
Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease
A study testing Bioelectric stimulation in people with Renal Insufficiency, Chronic and Electric Stimulation, run by Federal University of Health Science of Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Electric Stimulation
- What is being tested?
- Bioelectric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2021to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Renal Insufficiency, Chronic, Electric Stimulation
- Being tested
- Bioelectric stimulation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectric stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bioelectric stimulation | Experimental | Bioelectric stimulation on quadriceps muscle and kidneys: 45 minutes, 3 times/week, 8 weeks, 24 sessions. Receives: Device: Bioelectric stimulation |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from kidney function
The kidney function will be assessed through the blood collection and dosage of serum creatinine
Measured: 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
Measured: Baseline, after 4 weeks and after 8 weeks
Change from kidney function
The kidney function will be assessed through the glomerular filtration rate
Measured: Baseline, after 4 weeks and after 8 weeks
Secondary outcomes (8)
Change in functional capacity
Functional capacity will be assessed by change in distance covered in the six minute walk test
Measured: Baseline and after 8 weeks
Change in muscle strength
Muscle strength will be evaluated by dynamometry by a load cell
Measured: Baseline and after 8 weeks
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
Measured: Baseline and after 8 weeks
Change in quality of life evaluation
The quality of life will be assessed by questionnaire EuroQol-5D health questionnaire
Measured: Baseline and after 8 weeks
Adverse effects
Adverse effects will be recorded in number of cases and type of event
Measured: After 8 weeks
Change in inflammatory profile
The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 6
Measured: Baseline, after 4 weeks and after 8 weeks
Change in inflammatory profile
The inflammatory profile will be assessed through the blood collection and analysis of immunological marker interleukin 10
Measured: Baseline, after 4 weeks and after 8 weeks
Change in inflammatory profile
The inflammatory profile will be assessed through the blood collection and analysis of immunological marker tumor necrosis factor
Measured: Baseline, after 4 weeks and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start25 Nov 2021 (estimated)
- Primary completion25 Jun 2022 (estimated)
- Study completion25 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Leonhardt Ventures LLC, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Principal investigator, Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
- Investigators
- Rodrigo DM Plentz, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124756
- Sponsor's protocol ID
- CKD_EE_Klotho
- Status last verified
- Nov 2021
- First submitted
- 15 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bioelectric Stimulation on Kidney Function and Sarcopenia in Patients With Non-Dialysis Dependent Chronic Kidney Disease (CKD): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05124756
- Acronym / sponsor ID
- CKD_EE_Klotho
- Conditions
- Renal Insufficiency, Chronic, Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Leonhardt Ventures LLC, Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 25 Nov 2021 (estimated)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 25 Oct 2022 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioelectric stimulation | Experimental | Device: Bioelectric stimulationBioelectric stimulation on quadriceps muscle and kidneys: 45 minutes, 3 times/week, 8 weeks, 24 sessions. |
| Control | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectric stimulationThe 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. | Device | Bioelectric stimulation |
Primary outcome
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
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
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
8 secondary outcomes
Change in functional capacity
Time frame: Baseline and after 8 weeks
Change in muscle strength
Time frame: Baseline and after 8 weeks
Change in muscle strength of the lower limbs
Time frame: Baseline and after 8 weeks
Change in quality of life evaluation
Time frame: Baseline and after 8 weeks
Adverse effects
Time frame: After 8 weeks
Change in inflammatory profile
Time frame: Baseline, after 4 weeks and after 8 weeks
Change in inflammatory profile
Time frame: Baseline, after 4 weeks and after 8 weeks
Change in inflammatory profile
Time frame: Baseline, after 4 weeks and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo DM Plentz, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectric stimulation in people with Renal Insufficiency, Chronic and Electric Stimulation, run by Federal University of Health Science of Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo DM Plentz, PhD (+55 51 3303-8700, roplentz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from kidney function (time frame: Baseline, after 4 weeks and after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.