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

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ClinicalTrials.gov Identifier: NCT01325597
Recruitment Status : Unknown
Verified March 2015 by Graciele Sbruzzi, Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was:  Recruiting
First Posted : March 30, 2011
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Graciele Sbruzzi, Instituto de Cardiologia do Rio Grande do Sul

Brief Summary:
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 or disease Intervention/treatment
Heart Failure Other: Combined training Other: Electrical stimulation Other: Inspiratory muscle training Other: Control group

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial
Study Start Date : March 2010
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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
  • 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:
  • Respiratory muscle training
  • Breathing exercises
Other: Control group
No intervention
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:
  • Respiratory muscle training
  • Breathing exercises
Other: Control group
No intervention
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
  • Eletric stimulation therapy
Other: Control group
No intervention
No Intervention: Control group
No intervention.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Graciele Sbruzzi, Doutora, Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01325597     History of Changes
Other Study ID Numbers: UP 4546/10
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases