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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01325597
First received: March 14, 2011
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Other: Combined training
Other: Electrical stimulation
Other: Inspiratory muscle training
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • Functional capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life.

  • Peripheral muscle strength [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.

  • Pulmonary function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.

  • Respiratory muscle strength [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength.

  • Endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.

  • Autonomic control [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.

  • Oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined training
Training with functional electrical stimulation added by inspiratory muscle training.
 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
  • Electrical 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:
  • Inspiratory muscle training
  • Respiratory muscle training
  • Breathing exercises
Other: Control group
No intervention
Other Name: Control group
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: 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:
  • Electric stimulation
  • Electrical stimulation
  • Inspiratory muscle training
  • Breathing exercises
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:
  • Inspiratory muscle training
  • Respiratory muscle training
  • Breathing exercises
Other: Control group
No intervention
Other Name: Control group
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: 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:
  • Electric stimulation
  • Electrical stimulation
  • Inspiratory muscle training
  • Breathing exercises
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
  • Electrical stimulation
  • Eletric stimulation therapy
Other: Control group
No intervention
Other Name: Control group
No Intervention: Control group
No intervention.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325597

Contacts
Contact: Rodrigo DM Plentz, PhD + 55 51 91794399 roplentz@yahoo.com.br
Contact: Graciele Sbruzzi, MSc + 55 51 98899705 graci_sbruzzi@hotmail.com

Locations
Brazil
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90.620-000
Contact: Rodrigo DM Plentz, PhD     + 55 51 32192802     roplentz@yahoo.com.br    
Contact: Graciele Sbruzzi, MSc     + 55 51 32232746     graci_sbruzzi@hotmail.com    
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
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
  More Information

No publications provided

Responsible Party: Rodrigo Della Méa Plentz, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
ClinicalTrials.gov Identifier: NCT01325597     History of Changes
Other Study ID Numbers: UP 4546/10
Study First Received: March 14, 2011
Last Updated: March 29, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Heart failure
Electric stimulation
Breathing exercises

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013