Chronic Kidney Disease Stage 5NCT04608422
Bioeletric Stimulation in Patients With Chronic Kidney Failure
A study testing Electrical stimulation in people with Chronic Kidney Disease Stage 5 and Electric Stimulation, run by Federal University of Health Science of Porto Alegre.
Trial summary
This study aims to evaluate the effects of electrical stimulation on renal function and physical capacity in patients with chronic kidney disease (CKD). This is a randomized controlled trial with patients from the HD outpatient of Santa Clara hospital at Irmandade Santa Casa de Misericórdia de Porto Alegre (ISCMPA)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5, Electric Stimulation
- What is being tested?
- Electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 30 Apr 2021
- 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
- Patients with CKF on HD for a period ≥ 3 months;
- Kt/V ≥ 1.2 or URR ≥ 65%
- Age between 18 and 80 years old;
- Functional capacity ≥ 300 meters in the 6MWT.
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;
- Patients with sequelae of stroke;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension (SBP> 230 mmHg and DBP> 120 mmHg);
- Grade IV heart failure according to the New York Heart Association or decompensated;
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- Unstable angina;
- Peripheral vascular changes in the lower limbs such as deep vein thrombosis;
- Disabling osteoarticular or musculoskeletal disease;
- Uncontrolled diabetes (blood glucose> 300mg/dL);
- Feverish state and/or active infectious disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bioelectric Stimulation to Improve Kidney Function and Sarcopenia in Patients on Hemodialysis: Randomized Controlled Trial
This study aims to evaluate the effects of electrical stimulation on renal function and physical capacity in patients with chronic kidney disease (CKD). This is a randomized controlled trial with patients from the HD outpatient of Santa Clara hospital at Irmandade Santa Casa de Misericórdia de Porto Alegre (ISCMPA), who will be allocated to a control group (it will be evaluated and reassessed) or intervention group (it will receive electrical stimulation). Interventions will occur during the HD session, twice a week, for eight weeks, totaling 16 sessions. The groups will be evaluated prior to physiotherapy intervention and at the end. The following outcomes will be measured: renal function, functional capacity, muscle strength of lower limbs and quality of life.
Read the detailed description
Chronic kidney disease consists of kidney damage, with consequent progressive and irreversible loss of kidney function. Lower circulating levels of α-klotho protein are related to worsening kidney function and as it is affected, systemic changes occur and lead to the involvement of other organs. Supplementation of soluble α-Klotho protein carried out in experimental studies has been shown to be effective in protecting renal function, in addition to slowing the progression of CKD. Endogenously, physical exercise seems to be a way to increase circulating levels of α klotho. In addition, it is suggested that the contractile activity of the skeletal muscle modulates the expression of circulating Klotho. The practice of physical exercise is considered fundamental in the treatment of patients with CKD, since they present loss of muscle mass and decline in muscle function, and consequently low rates of physical activity and physical inactivity, which is strongly associated with mortality in this population.
As an alternative to mitigate the deleterious effects of sarcopenia in this population, studies have shown beneficial effects of electrical stimulation, such as increased muscle strength, functional capacity and protection against muscle atrophy of the lower limbs. In addition to the clinical and functional effects, electrostimulation reduces DNA damage in patients on hemodialysis (HD), suggesting that electrical stimulation has a systemic effect. In this context, the aim of this study is to evaluate the effects of electrical stimulation on renal function and physical capacity in patients with CKD on HD.
The sample will consist of 20 patients of both sexes, with CKD in stage V of the DRC recruited from the HD outpatient of Santa Clara hospital at ISCMPA. Patients will be randomized into an control or electrical stimulation group. The control group will be evaluated and reassessed. Evaluations will be carried out before and after follow-up: analysis of the plasma content of soluble α-Klotho and creatinine to assess renal function, six-minute walk test (6MWT) to assess functional capacity, sit-and-stand test (STS) with 10 repetitions and dynamometry per load cell to assess muscle strength of lower limbs and application of the EuroQoL-5D questionnaire for quality of life.
Electrical stimulation will be performed during HD, twice a week, for eight weeks, totaling 16 sessions. In the same session, a protocol of neuromuscular electrical stimulation will be applied to quadriceps muscle for 20 min. After, a protocol of sensory electrical stimulation will be applied on kidney anatomical region for 45 min.
At the end of the study, is expected from patients who received electrical stimulation an increase in kidney function and improvement on physical capacity, muscle strength and quality of life.
- Being tested
- Electrical 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.
Electrical stimulationOther
A protocol of neuromuscular electrical stimulation will be applied on the quadriceps muscle (symmetric biphasic pulsed current, 80 Hz, 400 µs, 10 s contraction time, 50s/30s/20s rest time, the reciprocal mode, 20 min. After, a protocol of sensory stimulation will be applied on the anatomical region of the kidneys (First: 50 pps, 300 µs, continuous mode for 5 min; Second: 30 pps, 100 µs, continuous mode for 10 min; Third: 20 pps, 1000 µs for 30 min).
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | The patients will receive neuromuscular electrical stimulation on quadriceps muscle and sensory stimulation in the anatomical region of the kidneys. Receives: Other: Electrical stimulation |
| Control | No intervention | The patients only will be evaluated and reassessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in soluble α-Klotho protein expression.
It will be assessed by the analysis of the plasma content by immunoassay assay (ELISA).
Measured: Baseline, after 4 weeks and after 8 weeks.
Change in serum creatinine.
It will be assessed by the analysis of the plasma content by spectrophotometry.
Measured: Baseline, after 4 weeks and after 8 weeks.
Secondary outcomes (4)
Functional capacity.
It will be assessed by the six-minute walk test (6MWT).
Measured: Baseline and after 8 weeks.
Muscle strength of lower limbs.
It will be evaluated by the sit-and-stand test with 10 repetitions.
Measured: Baseline and after 8 weeks.
Muscle strength of quadriceps.
It will be evaluated by dynamometry per load cell.
Measured: Evaluated: baseline and after 8 weeks.
Quality of life evaluation.
It will be assessed by the application of the EuroQoL-5D questionnaire.
Measured: Baseline 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 posted29 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC
- 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
- NCT04608422
- Sponsor's protocol ID
- CKF_BES
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 2 Nov 2020
- 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 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioelectric Stimulation to Improve Kidney Function and Sarcopenia in Patients on Hemodialysis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04608422
- Acronym / sponsor ID
- CKF_BES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 29 Oct 2020 (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.
This study aims to evaluate the effects of electrical stimulation on renal function and physical capacity in patients with chronic kidney disease (CKD). This is a randomized controlled trial with patients from the HD outpatient of Santa Clara hospital at Irmandade Santa Casa de Misericórdia de Porto Alegre (ISCMPA), who will be allocated to a control group (it will be evaluated and reassessed) or intervention group (it will receive electrical stimulation). Interventions will occur during the HD session, twice a week, for eight weeks, totaling 16 sessions. The groups will be evaluated prior to physiotherapy intervention and at the end. The following outcomes will be measured: renal function, functional capacity, muscle strength of lower limbs and quality of life.
Detailed description
Chronic kidney disease consists of kidney damage, with consequent progressive and irreversible loss of kidney function. Lower circulating levels of α-klotho protein are related to worsening kidney function and as it is affected, systemic changes occur and lead to the involvement of other organs. Supplementation of soluble α-Klotho protein carried out in experimental studies has been shown to be effective in protecting renal function, in addition to slowing the progression of CKD. Endogenously, physical exercise seems to be a way to increase circulating levels of α klotho. In addition, it is suggested that the contractile activity of the skeletal muscle modulates the expression of circulating Klotho. The practice of physical exercise is considered fundamental in the treatment of patients with CKD, since they present loss of muscle mass and decline in muscle function, and consequently low rates of physical activity and physical inactivity, which is strongly associated with mortality in this population.
As an alternative to mitigate the deleterious effects of sarcopenia in this population, studies have shown beneficial effects of electrical stimulation, such as increased muscle strength, functional capacity and protection against muscle atrophy of the lower limbs. In addition to the clinical and functional effects, electrostimulation reduces DNA damage in patients on hemodialysis (HD), suggesting that electrical stimulation has a systemic effect. In this context, the aim of this study is to evaluate the effects of electrical stimulation on renal function and physical capacity in patients with CKD on HD.
The sample will consist of 20 patients of both sexes, with CKD in stage V of the DRC recruited from the HD outpatient of Santa Clara hospital at ISCMPA. Patients will be randomized into an control or electrical stimulation group. The control group will be evaluated and reassessed. Evaluations will be carried out before and after follow-up: analysis of the plasma content of soluble α-Klotho and creatinine to assess renal function, six-minute walk test (6MWT) to assess functional capacity, sit-and-stand test (STS) with 10 repetitions and dynamometry per load cell to assess muscle strength of lower limbs and application of the EuroQoL-5D questionnaire for quality of life.
Electrical stimulation will be performed during HD, twice a week, for eight weeks, totaling 16 sessions. In the same session, a protocol of neuromuscular electrical stimulation will be applied to quadriceps muscle for 20 min. After, a protocol of sensory electrical stimulation will be applied on kidney anatomical region for 45 min.
At the end of the study, is expected from patients who received electrical stimulation an increase in kidney function and improvement on physical capacity, muscle strength and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Other: Electrical stimulationThe patients will receive neuromuscular electrical stimulation on quadriceps muscle and sensory stimulation in the anatomical region of the kidneys. |
| Control | No intervention | –The patients only will be evaluated and reassessed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with CKF on HD for a period ≥ 3 months;
- Kt/V ≥ 1.2 or URR ≥ 65%
- Age between 18 and 80 years old;
- Functional capacity ≥ 300 meters in the 6MWT.
Key exclusion criteria (11 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;
- Patients with sequelae of stroke;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension (SBP> 230 mmHg and DBP> 120 mmHg);
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 |
|---|---|---|
| Electrical stimulationA protocol of neuromuscular electrical stimulation will be applied on the quadriceps muscle (symmetric biphasic pulsed current, 80 Hz, 400 µs, 10 s contraction time, 50s/30s/20s rest time, the reciprocal mode, 20 min. After, a protocol of sensory stimulation will be applied on the anatomical region of the kidneys (First: 50 pps, 300 µs, continuous mode for 5 min; Second: 30 pps, 100 µs, continuous mode for 10 min; Third: 20 pps, 1000 µs for 30 min). | Other | Electrical stimulation |
Primary outcome
Change in soluble α-Klotho protein expression.
Time frame: Baseline, after 4 weeks and after 8 weeks.
It will be assessed by the analysis of the plasma content by immunoassay assay (ELISA).
Change in serum creatinine.
Time frame: Baseline, after 4 weeks and after 8 weeks.
It will be assessed by the analysis of the plasma content by spectrophotometry.
4 secondary outcomes
Functional capacity.
Time frame: Baseline and after 8 weeks.
Muscle strength of lower limbs.
Time frame: Baseline and after 8 weeks.
Muscle strength of quadriceps.
Time frame: Evaluated: baseline and after 8 weeks.
Quality of life evaluation.
Time frame: Baseline 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 2 Nov 2020.
- 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 Electrical stimulation in people with Chronic Kidney Disease Stage 5 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 4 inclusion and 11 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 2 Nov 2020. 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 5191131651, 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 in soluble α-Klotho protein expression. (time frame: Baseline, after 4 weeks and after 8 weeks.). The study lists 2 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 2 Nov 2020.