Functional Electrical Stimulation in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Electrical Stimulation
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic kidney disease on hemodialysis for more than 3 months;
- Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
Exclusion Criteria:
- Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
- Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change;
- Patients with recent sequel of stroke;
- Disabling musculoskeletal disease;
- Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
- Grade IV heart failure (NYHA) or decompensated;
- Uncontrolled diabetes (blood glucose > 300 mg/dL);
- Unstable angina;
- Fever and/or infectious disease;
- Recent acute myocardial infarction (two months);
- Active smokers; Peripheral vascular disease in the lower limbs as deep vein thrombosis or obliterates thromboangiitis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Functional electrical stimulation group
Control group
Arm Description
Functional electrical stimulation: 80 Hz frequency, 0.4 ms pulse, 10 s time on, 50-20s time off, intensity as patient tolerance, total session time ranged from 20 to 34 minutes.
The patients in this group were evaluated at baseline and reassessed after eight weeks of follow-up.
Outcomes
Primary Outcome Measures
Functional capacity
Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT).
Secondary Outcome Measures
Muscle architecture
Assessment of muscle architecture will take place with the acquisition of ultrasound images of the medialis and lateralis vastus and rectus femorals through an ultrasound device (Vivid-i, GE, USA). After, the thickness of the muscles will be undertaken in the software ImageJ.
Muscle strength of the lower limbs
Muscle strength will be evaluated by dynamometry by a load cell.
Endurance of the lower limbs
The endurance of the lower limbs will be assessed by the number of repetitions performed in sit-and-stand test (STST).
Endothelial function
Will be used a high-resolution ultrasound machine (Vivid-i, GE, USA) for evaluation of non-invasive blood endothelial function. Endothelial function will be assessed by flow mediated dilation technique.
Inflammatory profile
The inflammatory profile will be assessed through blood collection and analysis of biochemical and immunological markers such as interleukin 6, tumor necrosis factor, creatine kinase, lactate and C-reactive protein.
DNA damage
The damage to DNA is analyzed by electrophoresis single (comet technique), where cells are counted by microscopy.
Quality of Life
The quality of life will be assessed by questionnaire Kidney Disease and Quality-of-Life Short-Form (KDQOL-SFTM).
Full Information
NCT ID
NCT02336776
First Posted
January 7, 2015
Last Updated
January 8, 2015
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT02336776
Brief Title
Functional Electrical Stimulation in Chronic Kidney Disease
Official Title
Effects of Functional Electrical Stimulation on Muscle Architecture of Patients With Chronic Kidney Disease: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (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, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney function and in its most advanced stage is called chronic renal failure.
Although hemodialysis replace some kidney function, patients suffer some alterations characterized by "uremic syndrome" typically expressed by: motor neuropathy and/or autonomic neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thereby, the the adoption of physical exercise should be encouraged. However, it is known that the ability to exercise the subject in hemodialysis is low and keeping in mind the weakness of the muscular system in these individuals, the aim of this study is to assess the effects of functional electrical stimulation (FES) on muscle architecture of patients with chronic kidney disease hemodialysis.
For this the following assessments will be performed before and after stimulation: ultrasonography to assess muscle architecture; six-minute walk test to functional capacity; Kidney Disease and Quality of Life - Short Form questionnaire for quality of life; sit and stand test for resistance of the lower limbs; dynamometric by load cell for muscle strength of the lower limbs; flow-mediated dilatation to endothelial function; blood collection for analysis of inflammatory markers and DNA damage.
The subjects will be randomized into two groups, FESG (functional electrical stimulation group) and CG (control group). The first will receive the FES in the quadriceps muscle of both thighs, for eight weeks, three times a week during hemodialysis session. While the control group only will be evaluated and re-evaluated.
Expected results at the end of the protocol with FES are: increased quadriceps muscle thickness; longest distance covered on the six-minute walk test; improved quality of life; increase in resistance of the lower limbs; increased muscle strength of the lower limbs; improved endothelial function; improved inflammatory status and DNA damage.
Detailed Description
The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa Casa de Misericordia de Porto Alegre.
After the selection of patients for eligibility criteria they will be randomized into functional electrical stimulation group or control group. First all patients will be evaluated, and subsequently the patients in the functional electrical stimulation group will be trained three times per week for eight weeks using an electric current called functional electrical stimulation through the stimulator device NEURODYN II, IBRAMED mark, Amparo, Sao Paulo, Brazil.
The sessions took place in the first hour of dialysis and will last at least 20 and maximum of 34 minutes. The parameters selected in the stimulator will be: 80 Hz frequency, 0.4 ms pulse, 10 s time on, 50-20s time off, intensity as patient tolerance. The patient will be positioned supine, the knees will be at 60° flexion through a foam wedge and ankles restrained by a band to make isometric exercise.
Furthermore, the electrodes used to perform the electrical stimulation will adhesive, disposable and hypoallergenic. These will be placed over the motor points of the quadriceps muscle of both legs in order to make the most effective contraction.
At the end of follow-up, both groups will be further evaluated in order to compare.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Electrical Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional electrical stimulation group
Arm Type
Experimental
Arm Description
Functional electrical stimulation: 80 Hz frequency, 0.4 ms pulse, 10 s time on, 50-20s time off, intensity as patient tolerance, total session time ranged from 20 to 34 minutes.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in this group were evaluated at baseline and reassessed after eight weeks of follow-up.
Intervention Type
Other
Intervention Name(s)
Functional electrical stimulation
Other Intervention Name(s)
FES
Intervention Description
Functional electrical stimulation will be applied through self adhesive electrodes on the quadriceps muscle of both thighs, and these will be positioned at 60° of flexion and contained by a band for that exercise happen isometric form.
Parameter settings in the electrical stimulator are as follows: 80 Hz frequency, 0.4 ms pulse, 10 s time on, 50-20 s time off, intensity according to the patient's tolerance but enough to cause visible muscle contraction. The total time of each session starts at twenty minutes and is increased every week a total thirty-four minutes at the end of the eighth week. Intervention will be held three times a week for eight weeks and during hemodialysis session.
Primary Outcome Measure Information:
Title
Functional capacity
Description
Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT).
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Muscle architecture
Description
Assessment of muscle architecture will take place with the acquisition of ultrasound images of the medialis and lateralis vastus and rectus femorals through an ultrasound device (Vivid-i, GE, USA). After, the thickness of the muscles will be undertaken in the software ImageJ.
Time Frame
Eight weeks
Title
Muscle strength of the lower limbs
Description
Muscle strength will be evaluated by dynamometry by a load cell.
Time Frame
Four and eight weeks
Title
Endurance of the lower limbs
Description
The endurance of the lower limbs will be assessed by the number of repetitions performed in sit-and-stand test (STST).
Time Frame
Four and eight weeks
Title
Endothelial function
Description
Will be used a high-resolution ultrasound machine (Vivid-i, GE, USA) for evaluation of non-invasive blood endothelial function. Endothelial function will be assessed by flow mediated dilation technique.
Time Frame
Eight weeks
Title
Inflammatory profile
Description
The inflammatory profile will be assessed through blood collection and analysis of biochemical and immunological markers such as interleukin 6, tumor necrosis factor, creatine kinase, lactate and C-reactive protein.
Time Frame
Four and eight weeks
Title
DNA damage
Description
The damage to DNA is analyzed by electrophoresis single (comet technique), where cells are counted by microscopy.
Time Frame
Four and eight weeks
Title
Quality of Life
Description
The quality of life will be assessed by questionnaire Kidney Disease and Quality-of-Life Short-Form (KDQOL-SFTM).
Time Frame
Eight 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 chronic kidney disease on hemodialysis for more than 3 months;
Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
Exclusion Criteria:
Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change;
Patients with recent sequel of stroke;
Disabling musculoskeletal disease;
Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
Grade IV heart failure (NYHA) or decompensated;
Uncontrolled diabetes (blood glucose > 300 mg/dL);
Unstable angina;
Fever and/or infectious disease;
Recent acute myocardial infarction (two months);
Active smokers; Peripheral vascular disease in the lower limbs as deep vein thrombosis or obliterates thromboangiitis.
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
Learn more about this trial
Functional Electrical Stimulation in Chronic Kidney Disease
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