Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients

March 10, 2015 updated by: Graciele Sbruzzi, Instituto de Cardiologia do Rio Grande do Sul

Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial

The purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity and quality of life in patients with heart failure (HF). A randomized clinical trial with 60 HF patients (functional class II-IV) will be randomly assigned to the FES, IMT, IMT associated with FES or control group. FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. Acute and chronic effects of interventions on functional capacity, quality of life, peripheral muscle strength, pulmonary function, respiratory muscle strength and endurance, endothelial function, autonomic control and oxidative stress will be analyzed in these patients.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90.620-000
        • Recruiting
        • Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with stable heart failure and New York Heart Association (NYHA) class II-IV
  • Aged 30-70 years
  • Left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study)

Exclusion Criteria:

  • Patients with unstable heart failure
  • NYHA class I
  • Unstable angina pectoris and ventricular arrhythmia
  • Implanted cardiac pacemaker
  • Acute pulmonary diseases
  • Chronic renal failure or dialysis
  • Acute myocardial infarction 3 months before the inclusion in the study
  • Acute inflammatory diseases
  • Peripheral vascular disease
  • Neurologic disease
  • Musculoskeletal pathologies
  • Malignancies or being an active smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention.
Experimental: Combined training
Training with functional electrical stimulation added by inspiratory muscle training.
Other: Control group
No intervention
Other: Electrical stimulation
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Other Names:
  • Electric stimulation
  • Eletric stimulation therapy
Other: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Other Names:
  • Breathing exercises
  • Respiratory muscle training
Experimental: Electrical stimulation
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Other: Control group
No intervention
Other: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Other Names:
  • Breathing exercises
  • Respiratory muscle training
Other: Combined training
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
Other Names:
  • Electrical stimulation
  • Inspiratory muscle training
  • Electric stimulation
  • Breathing exercises
Experimental: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Other: Control group
No intervention
Other: Electrical stimulation
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
Other Names:
  • Electric stimulation
  • Eletric stimulation therapy
Other: Combined training
FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
Other Names:
  • Electrical stimulation
  • Inspiratory muscle training
  • Electric stimulation
  • Breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life.
12 weeks
Peripheral muscle strength
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.
12 weeks
Pulmonary function
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.
12 weeks
Respiratory muscle strength
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength.
12 weeks
Endothelial function
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.
12 weeks
Autonomic control
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.
12 weeks
Oxidative stress
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Rodrigo DM Plentz, PhD, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP 4546/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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