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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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