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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Heart Failure

Treatments: Other: Functional electrical stimulation; Other: Placebo electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01886430

FES

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Functional Electrical Stimulation

Experimental group

Description:

Functional Electrical Stimulation for 10 days

Treatment:

Other: Functional electrical stimulation

Control Electrical Stimulation

Placebo Comparator group

Description:

Control Electrical Stimulation for 10 days

Treatment:

Other: Placebo electrical stimulation