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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886430
• Other study ID #: FES
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: December 2, 2015
• Start date: May 2009
• Est. completion date: December 2014

Study information

• Verified date: April 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Functional electrical stimulation
Functional electrical stimulation for 10 days
• Placebo electrical stimulation
Placebo electrical stimulation for 10 days

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HC/FMUSP	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional assessment	To assess the effects of the functional electrical stimulation in patients with advanced heart failure.	10 days	No
Secondary	Peripheral function	To assess the effects of the functional electrical stimulation in patients with advanced heart failure.	10 days	No
Secondary	Peripheral muscle strength	To assess the effects of the functional electrical stimulation in patients with advanced heart failure.	10 days	No