Diaphragmatic Functional Electrical Stimulation in Heart Failure

Diaphragmatic Functional Electrical Stimulation in Heart Failure Patients: Uncontrolled Clinical Trial

Heart failure is an incapacity to provide adequate blood flow to the others organs, such as brain, liver and kidney. The patients presents weakness and fatigue of inspiratory muscles, mainly diaphragm muscle, that contributes to dyspnoea and limited physical capacity in this patients.

Some methods are being studied to decrease the diaphragm weakness. The diaphragm functional eletrical stimulation is a new technique, which has been studied to improve the respiratory muscle strength. Then, the aim of this study is to assess the effects of diaphragm functional electrical stimulation (FES) on respiratory muscle strength and muscle architecture of patients with heart failure.

For this the following assessments will be performed before and after stimulation: manovacuometry to verify the maximum inspiratory pressure and maximum expiratory pressure; and ultrasonography to assess muscle architecture.

The subjects will be selected by the decompensation in heart failure, with the adequate elegibility criteria. This study have no control group, because this technique has been little researched and could be unethical with the patient who won't receive this treatment.

The subjetcs of this research will receive the diaphragm functional electrical stimulation twice of day for consecutive five days or until the hospital discharge.

Expected results at the end of the protocol with Diaphragm Functional Electrical Stimulation are: to improve respiratory muscle strength; to correlate with diaphragm muscle arquiteture.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Other: Diaphragm functional electrical stimulation

Detailed Description

The research will be developed in the São Francisco Hospital, of Santa Casa de Misericordia de Porto Alegre. After the selection of patients for eligibility criteria they will be evaluated, and subsequently the patients in will be trained twice of day for five days or until hospital discharge. Will be use an electric current called functional electrical stimulation through the stimulator device NEURODYN II, IBRAMED mark, Amparo, São Paulo, Brazil.

Each session will last 30 minutes. The parameters selected in the stimulator will be: 80 Hz frequency, 0.4 ms pulse, rise 1s, 1s time on, decay 2s, 1s time off, intensity as patient tolerance.

The patient will be positioned supine, headboard 30º, knees extended. Furthermore, the electrodes used to perform the electrical stimulation will be adhesive, disposable and hypoallergenic. These will be placed at sixth, seventh and eighth intercostal spaces, axiliar medium line and paraxiphoid both chest sides.

At the end of follow-up, will be compared the data of before and after interventions.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Recruiting
      • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Contact: Rodrigo DM Plentz, PhD; Phone Number: 555133038835
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Recruiting
      • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Contact: Rodrigo DM Plentz, PhD; Phone Number: 555133038835; Email: roplentz@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with heart failure, being admited at the hospital for decompensation of the disease

Exclusion Criteria:

• Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
• Epidermal lesions at the site of application and/or intolerance stimulator and/or skin sensitivity change;
• Use pacemaker, cardiac resynchronization and/or implantable cardioverter defibrillator;
• Body mass index >40Kg/m²

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DFES group; Diaphragm Functional Electrical Stimulation: Each session will last 30 minutes. The parameters selected in the stimulator will be: 80 Hz frequency, 0.4 ms pulse, rise 1s, 1s time on, decay 2s, 1s time off, intensity as patient tolerance. The patient will be positioned supine, headboard 30º, knees extended. Furthermore, the electrodes used to perform the electrical stimulation will be adhesive, disposable and hypoallergenic. These will be placed at sixth, seventh and eighth intercostal spaces, axiliar medium line and paraxiphoid both chest sides.

Other: Diaphragm functional electrical stimulation; Functional electrical stimulation: 80 Hz frequency, 0.4 ms pulse, rise 1s, 1s time on, decay 2s, 1s time off, intensity as patient tolerance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength assessed by manovacuometry	Respiratory muscle strength assessed by manovacuometry	Five days or until hospital discharge

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Heart Failure; Diaphragm; Electrical Stimulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DFESHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes