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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Placebo electrical stimulation; Other: Functional electrical stimulation

• Registration Number: NCT01886430
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-05
• Status Verified: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Electrical Stimulation	Placebo electrical stimulation	Control Electrical Stimulation for 10 days
Functional Electrical Stimulation	Functional electrical stimulation	Functional Electrical Stimulation for 10 days

Primary Outcome Measures

Name	Time	Method
Functional assessment	10 days	To assess the effects of the functional electrical stimulation in patients with advanced heart failure.

Secondary Outcome Measures

Name	Time	Method
Peripheral muscle strength	10 days	To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
Peripheral function	10 days	To assess the effects of the functional electrical stimulation in patients with advanced heart failure.

Trial Locations

Locations (1)

Instituto do Coração - HC/FMUSP; 🇧🇷 Sao Paulo, Brazil