Bioeletric Stimulation in Patients With Chronic Kidney Failure
Primary Purpose
Chronic Kidney Disease Stage 5, Electric Stimulation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Stage 5
Eligibility Criteria
Inclusion Criteria:
- 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.
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;
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Electrical stimulation
Control
Arm Description
The patients will receive neuromuscular electrical stimulation on quadriceps muscle and sensory stimulation in the anatomical region of the kidneys.
The patients only will be evaluated and reassessed.
Outcomes
Primary Outcome Measures
Change in soluble α-Klotho protein expression.
It will be assessed by the analysis of the plasma content by immunoassay assay (ELISA).
Change in serum creatinine.
It will be assessed by the analysis of the plasma content by spectrophotometry.
Secondary Outcome Measures
Functional capacity.
It will be assessed by the six-minute walk test (6MWT).
Muscle strength of lower limbs.
It will be evaluated by the sit-and-stand test with 10 repetitions.
Muscle strength of quadriceps.
It will be evaluated by dynamometry per load cell.
Quality of life evaluation.
It will be assessed by the application of the EuroQoL-5D questionnaire.
Full Information
NCT ID
NCT04608422
First Posted
October 23, 2020
Last Updated
October 29, 2020
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC
1. Study Identification
Unique Protocol Identification Number
NCT04608422
Brief Title
Bioeletric Stimulation in Patients With Chronic Kidney Failure
Official Title
Bioelectric Stimulation to Improve Kidney Function and Sarcopenia in Patients on Hemodialysis: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre, Leonhardt Ventures LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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), 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5, Electric Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electrical stimulation
Arm Type
Experimental
Arm Description
The patients will receive neuromuscular electrical stimulation on quadriceps muscle and sensory stimulation in the anatomical region of the kidneys.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients only will be evaluated and reassessed.
Intervention Type
Other
Intervention Name(s)
Electrical stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in soluble α-Klotho protein expression.
Description
It will be assessed by the analysis of the plasma content by immunoassay assay (ELISA).
Time Frame
Baseline, after 4 weeks and after 8 weeks.
Title
Change in serum creatinine.
Description
It will be assessed by the analysis of the plasma content by spectrophotometry.
Time Frame
Baseline, after 4 weeks and after 8 weeks.
Secondary Outcome Measure Information:
Title
Functional capacity.
Description
It will be assessed by the six-minute walk test (6MWT).
Time Frame
Baseline and after 8 weeks.
Title
Muscle strength of lower limbs.
Description
It will be evaluated by the sit-and-stand test with 10 repetitions.
Time Frame
Baseline and after 8 weeks.
Title
Muscle strength of quadriceps.
Description
It will be evaluated by dynamometry per load cell.
Time Frame
Evaluated: baseline and after 8 weeks.
Title
Quality of life evaluation.
Description
It will be assessed by the application of the EuroQoL-5D questionnaire.
Time Frame
Baseline 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:
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.
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;
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo DM Plentz, PhD
Phone
+55 5191131651
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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Bioeletric Stimulation in Patients With Chronic Kidney Failure
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