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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01886430

Enrollment

Registered

2013-06-25

Start date

2009-05-31

Completion date

2014-12-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHERFunctional electrical stimulation

Functional electrical stimulation for 10 days

OTHERPlacebo electrical stimulation

Placebo electrical stimulation for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026