Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF

Study Overview
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Brief Summary
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The purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.

Detailed Description
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The aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70mA. The session will last 60 minuts. It will be held every weekday for a period of 10 days. The effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.

Official Title
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Effects of Low-frequency Electrical Stimulation in Sympathetic Nerve Activity and Peripheral Vasoconstriction in Patients With Advanced HF

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Functional electrical stimulation
* Other: Placebo electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced heart failure, Class Functional IV, according to the criteria of New York Heart Association (NYHA), Aged over 18 years, Etiology hypertensive, ischemic, idiopathic or chagas disease, Left ventricular ejection fraction ≤ 30%. Exclusion Criteria: Patients with hypertension lung disease and oxygen-dependent, Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs, Insulin-dependent diabetes mellitus (type I), Peripheral arterial occlusive disease, Peripheral neuropathy, Use of pacemaker or implantable cardiodefibrillator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Electrical Stimulation<br>Functional Electrical Stimulation for 10 days | Other: Functional electrical stimulation<br>* Functional electrical stimulation for 10 days<br>|
| Placebo Comparator: Control Electrical Stimulation<br>Control Electrical Stimulation for 10 days | Other: Placebo electrical stimulation<br>* Placebo electrical stimulation for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional assessment | To assess the effects of the functional electrical stimulation in patients with advanced heart failure. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral function | To assess the effects of the functional electrical stimulation in patients with advanced heart failure. | 10 days | 
| Peripheral muscle strength | To assess the effects of the functional electrical stimulation in patients with advanced heart failure. | 10 days |