Renal Insufficiency, ChronicNCT06502522
Effects of Whole-body Electrostimulation on Patients With Chronic Kidney Disease
A study testing Whole-body electrical stimulation in people with Renal Insufficiency, Chronic, run by Federal University of Health Science of Porto Alegre.
Trial summary
Chronic kidney disease (CKD) consists of kidney damage, with consequent progressive and irreversible loss of kidney function. In the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, 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
- What is being tested?
- Whole-body electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Mar 2025
- 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 diagnosed with CKD (≥ 3 months) in stages 3-4 (GFR between 59 and 15 ml/min/1.73m2);
- Age between 18 and 80 years old;
- Functional capacity ≥ 300 meters in the six-minute walk test.
Who cannot join
- Cognitive dysfunction that prevents assessments from being carried out or inability to understand and sign the informed consent form;
- Intolerance to electrical stimulator and/or changes in skin sensitivity;
- Skin injuries or burns where the electrodes are positioned;
- Patients with stroke sequelae;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension (SBP>230 mmHg and DBP>120 mmHg);
Show all 17Show fewer
- New York Heart Association grade IV heart failure or decompensated;
- Unstable angina or arrhythmia;
- Artificial cardiac pacemaker or implantable cardioverter defibrillator;
- Peripheral vascular changes in the lower limbs such as deep vein thrombosis;
- Disabling osteoarticular or musculoskeletal disease;
- Uncontrolled diabetes (glycemia > 300mg/dL);
- Patients with cancer and/or undergoing oncological treatment;
- Epilepsy;
- Hemophilia;
- Chronic obstructive pulmonary disease;
- Grade II obesity (BMI≥35).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Whole-body Electrostimulation on Kidney Function and Physical Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
Chronic kidney disease (CKD) consists of kidney damage, with consequent progressive and irreversible loss of kidney function. In the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, which is related to worsening renal function. Therapeutic strategies that increase serum levels of α-klotho may be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the effectiveness rate of dialysis, suggesting a systemic effect in patients with terminal CKD. The objective of this study is to evaluate the effects of whole body electrical stimulation on renal function and physical capacity in patients with CKD not dependent on dialysis.
Read the detailed description
Patients with stage III and IV chronic kidney disease will be randomized into two groups, one group will receive whole-body electrical stimulation and the other group will be a control group (it will only be evaluated and reevaluated at the same times as the intervention group). The intervention group will perform the protocol three times a week, for eight weeks. The following assessments will be conducted pre- and post-intervention: analysis of plasma content of soluble α-Klotho and creatinine to assess renal function; measurement of interleukins and tumor necrosis factor by ELISA to analyze the inflammatory profile; beta-endorphin measurement by ELISA to assess well-being; creatine kinase dosage to assess muscle damage; 10-repetition sit-to-stand test and quadriceps muscle dynamometry to assess lower limb muscle strength; handgrip test with a dynamometer to assess upper limb strength; six-minute walk test to assess functional capacity; application of the EuroQoL-5D questionnaire for quality of life and the Pittsburgh scale to assess sleep quality.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Whole-body 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.
Whole-body electrical stimulationOther
Also called Whole-body electrical muscle stimulation, Whole-body neuromuscular electrical stimulation, Whole-body electromyostimulation
Symmetrical biphasic current, pulse width of 400 μs, frequency of 75 Hz, contraction time of five seconds and rest time of 10 seconds. The intensity will be individually adjusted to the patient's maximum tolerance limit to reach the motor threshold and the volunteer will be instructed to achieve a score of 7 on the modified BORG scale to ensure a moderate-intense effort. The session time will be 16 minutes, resulting in a total of 64 contractions per session. The progression of overload will only occur with an increase in the intensity of all muscle groups during the sessions.
Concomitantly with the electrical stimuli, the volunteer will perform exercises for the upper, lower limbs and trunk. After performing neuromuscular electrical stimulation, the patient will remain in the supine position to receive sensory stimulation throughout the body. The parameters used will be: frequency of 20 Hz and pulse width of 400 μs for 44 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Whole-body neuromuscular electrical stimulation will be administered for three times week for eight weeks, totaling 24 sessions. Receives: Other: Whole-body electrical stimulation |
| Control group | No intervention | No intervention will be carried out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kidney function
Change in kidney function will be assessed by alpha klotho protein dosage
Measured: Baseline, after 4 and 8 weeks
Change in kidney function
Change in kidney function will be assessed by serum creatinine measurement
Measured: Baseline, after 4 and 8 weeks
Secondary outcomes (11)
Change in inflammatory profile
Change in inflammatory profile will be assessed by measurement of interleukin 6 (IL6)
Measured: Baseline, after 4 and 8 weeks
Change in inflammatory profile
Change in inflammatory profile will be assessed by measurement of interleukin 10 (IL10)
Measured: Baseline, after 4 and 8 weeks
Change in inflammatory profile
Change in inflammatory profile will be assessed by measurement of tumor necrosis factor alpha (TNF-a)
Measured: Baseline, after 4 and 8 weeks
Change in well-being levels
Change in well-being levels will be assessed by serum beta-endorphin dosage
Measured: Baseline, after 4 and 8 weeks
Change in muscle damage levels
Change in muscle damage levels will be assessed by serum creatine kinase (CK) measurement
Measured: Baseline, after 4 and 8 weeks
Change in isometric muscle strength of the quadriceps
Change in isometric muscle strength of the quadriceps will be assessed by dynamometry
Measured: Baseline and 8 weeks
Change in handgrip muscle strength
Change in handgrip muscle strength will be assessed by dynamometry
Measured: Baseline and 8 weeks
Change in lower limb muscle strength
Change in lower limb muscle strength will be assessed using the 10-repetition sit-and-stand test (10SST)
Measured: Baseline and 8 weeks
Change in functional capacity
Change in functional capacity will be assessed through the distance covered in the six-minute walk test (6MWT)
Measured: Baseline and 8 weeks
Change in sleep quality
Change in sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).The score ranges from 0 to 21. Lower scores reflect worse sleep quality.
Measured: Baseline and 8 weeks
Change in quality of life
Change in quality of life will be assessed using the EuroQoL-5D (EQ-5D) questionnaire
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (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
- None (open label)
- 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
- Responsible party
- Principal investigator, Jociane Schardong, Federal University of Health Science of Porto Alegre
- Investigators
- Jociane Schardong, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502522
- Sponsor's protocol ID
- WB-EMS-KIDNEY
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Electrostimulation on Kidney Function and Physical Capacity of Patients With Chronic Kidney Disease: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06502522
- Acronym / sponsor ID
- WB-EMS-KIDNEY
- Conditions
- Renal Insufficiency, Chronic
- 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
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 16 Jul 2024 (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 consequent progressive and irreversible loss of kidney function. In the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, which is related to worsening renal function. Therapeutic strategies that increase serum levels of α-klotho may be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the effectiveness rate of dialysis, suggesting a systemic effect in patients with terminal CKD. The objective of this study is to evaluate the effects of whole body electrical stimulation on renal function and physical capacity in patients with CKD not dependent on dialysis.
Detailed description
Patients with stage III and IV chronic kidney disease will be randomized into two groups, one group will receive whole-body electrical stimulation and the other group will be a control group (it will only be evaluated and reevaluated at the same times as the intervention group). The intervention group will perform the protocol three times a week, for eight weeks. The following assessments will be conducted pre- and post-intervention: analysis of plasma content of soluble α-Klotho and creatinine to assess renal function; measurement of interleukins and tumor necrosis factor by ELISA to analyze the inflammatory profile; beta-endorphin measurement by ELISA to assess well-being; creatine kinase dosage to assess muscle damage; 10-repetition sit-to-stand test and quadriceps muscle dynamometry to assess lower limb muscle strength; handgrip test with a dynamometer to assess upper limb strength; six-minute walk test to assess functional capacity; application of the EuroQoL-5D questionnaire for quality of life and the Pittsburgh scale to assess sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Whole-body electrical stimulationWhole-body neuromuscular electrical stimulation will be administered for three times week for eight weeks, totaling 24 sessions. |
| Control group | No intervention | –No intervention will be carried out. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CKD (≥ 3 months) in stages 3-4 (GFR between 59 and 15 ml/min/1.73m2);
- Age between 18 and 80 years old;
- Functional capacity ≥ 300 meters in the six-minute walk test.
Key exclusion criteria (17 listed)
- Cognitive dysfunction that prevents assessments from being carried out or inability to understand and sign the informed consent form;
- Intolerance to electrical stimulator and/or changes in skin sensitivity;
- Skin injuries or burns where the electrodes are positioned;
- Patients with stroke sequelae;
- Recent acute myocardial infarction (two months);
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 |
|---|---|---|
| Whole-body electrical stimulationAlso: Whole-body electrical muscle stimulation, Whole-body neuromuscular electrical stimulation, Whole-body electromyostimulationSymmetrical biphasic current, pulse width of 400 μs, frequency of 75 Hz, contraction time of five seconds and rest time of 10 seconds. The intensity will be individually adjusted to the patient's maximum tolerance limit to reach the motor threshold and the volunteer will be instructed to achieve a score of 7 on the modified BORG scale to ensure a moderate-intense effort. The session time will be 16 minutes, resulting in a total of 64 contractions per session. The progression of overload will only occur with an increase in the intensity of all muscle groups during the sessions. Concomitantly with the electrical stimuli, the volunteer will perform exercises for the upper, lower limbs and trunk. After performing neuromuscular electrical stimulation, the patient will remain in the supine position to receive sensory stimulation throughout the body. The parameters used will be: frequency of 20 Hz and pulse width of 400 μs for 44 minutes. | Other | Intervention group |
Primary outcome
Change in kidney function
Time frame: Baseline, after 4 and 8 weeks
Change in kidney function will be assessed by alpha klotho protein dosage
Change in kidney function
Time frame: Baseline, after 4 and 8 weeks
Change in kidney function will be assessed by serum creatinine measurement
11 secondary outcomes
Change in inflammatory profile
Time frame: Baseline, after 4 and 8 weeks
Change in inflammatory profile
Time frame: Baseline, after 4 and 8 weeks
Change in inflammatory profile
Time frame: Baseline, after 4 and 8 weeks
Change in well-being levels
Time frame: Baseline, after 4 and 8 weeks
Change in muscle damage levels
Time frame: Baseline, after 4 and 8 weeks
Change in isometric muscle strength of the quadriceps
Time frame: Baseline and 8 weeks
Change in handgrip muscle strength
Time frame: Baseline and 8 weeks
Change in lower limb muscle strength
Time frame: Baseline and 8 weeks
Change in functional capacity
Time frame: Baseline and 8 weeks
Change in sleep quality
Time frame: Baseline and 8 weeks
Change in quality of life
Time frame: Baseline and 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 Jul 2024.
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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.
Jociane Schardong, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body electrical stimulation in people with Renal Insufficiency, Chronic, 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 Jul 2024. 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 Jociane Schardong, PhD (55981348114, joci_fisioufsm@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 kidney function (time frame: Baseline, after 4 and 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 18 Jul 2024.