NCT02931708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

September 1, 2016

Last Update Submit

October 11, 2016

Conditions

Heart Failure

Keywords

Heart FailureDiaphragmElectrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength assessed by manovacuometry

    Respiratory muscle strength assessed by manovacuometry

    Five days or until hospital discharge

Study Arms (1)

DFES group

EXPERIMENTAL

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

Interventions

Diaphragm functional electrical stimulationOTHER

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

DFES group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Rodrigo DM Plentz, PhD

    Federal University of Health Sciences of Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo DM Plentz, PhD

CONTACT

555133038835roplentz@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 1, 2016

First Posted

October 13, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

BR(2)