Clinical trial NCT02336776: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Electrical Stimulation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2015-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional capacity
timeFrame: Eight weeks
Secondary outcomes:
measure: Muscle architecture
timeFrame: Eight weeks
measure: Muscle strength of the lower limbs
timeFrame: Four and eight weeks
measure: Endurance of the lower limbs
timeFrame: Four and eight weeks
measure: Endothelial function
timeFrame: Eight weeks
measure: Inflammatory profile
timeFrame: Four and eight weeks
measure: DNA damage
timeFrame: Four and eight weeks
measure: Quality of Life
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Rodrigo DM Plentz, PhD
role: PRINCIPAL_INVESTIGATOR
References: