Functional Electrical Stimulation in Chronic Kidney Disease

NCT02336776 | Unknown DMC

• 1 other identifier: FESCKD
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT).

  Eight weeks

Secondary Outcomes (7)

• Muscle architecture

  Eight weeks

• Muscle strength of the lower limbs

  Four and eight weeks

• Endurance of the lower limbs

  Four and eight weeks

• Endothelial function

  Eight weeks

• Inflammatory profile

  Four and eight weeks

Study Arms (2)

Functional electrical stimulation group

EXPERIMENTAL

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.

Other: Functional electrical stimulation

Control group

NO INTERVENTION

The patients in this group were evaluated at baseline and reassessed after eight weeks of follow-up.

Interventions

Functional electrical stimulation OTHER

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.

Also known as: FES

Functional electrical stimulation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic kidney disease on hemodialysis for more than 3 months;
• Clearance of urea during hemodialysis (Kt/V ≥ 1.2).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo DM Plentz, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 13, 2015
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2015
• Last Updated: January 13, 2015

Record last verified: 2015-01