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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
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 5

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

    Learn more about this trial

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