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Diaphragmatic Functional Electrical Stimulation in Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Diaphragm functional electrical stimulation
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Diaphragm, Electrical Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irmandade Santa Casa de Misericórdia de Porto AlegreRecruiting
  • Irmandade Santa Casa de Misericórdia de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DFES group

Arm Description

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.

Outcomes

Primary Outcome Measures

Respiratory muscle strength assessed by manovacuometry
Respiratory muscle strength assessed by manovacuometry

Secondary Outcome Measures

Full Information

First Posted
September 1, 2016
Last Updated
October 11, 2016
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02931708
Brief Title
Diaphragmatic Functional Electrical Stimulation in Heart Failure
Official Title
Diaphragmatic Functional Electrical Stimulation in Heart Failure Patients: Uncontrolled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Diaphragm, Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DFES group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragm functional electrical stimulation
Intervention Description
Functional electrical stimulation: 80 Hz frequency, 0.4 ms pulse, rise 1s, 1s time on, decay 2s, 1s time off, intensity as patient tolerance
Primary Outcome Measure Information:
Title
Respiratory muscle strength assessed by manovacuometry
Description
Respiratory muscle strength assessed by manovacuometry
Time Frame
Five days or until hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo DM Plentz, PhD
Phone
555133038835
Email
roplentz@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Phone
555133038835
Facility Name
Irmandade Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Phone
555133038835
Email
roplentz@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Diaphragmatic Functional Electrical Stimulation in Heart Failure

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