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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Combined training
Electrical stimulation
Inspiratory muscle training
Control group
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Electric stimulation, Breathing exercises

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Combined training

Electrical stimulation

Inspiratory muscle training

Control group

Arm Description

Training with functional electrical stimulation added by inspiratory muscle 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

IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure

No intervention.

Outcomes

Primary Outcome Measures

Functional capacity
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
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life.
Peripheral muscle strength
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.
Pulmonary function
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.
Respiratory muscle strength
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength.
Endothelial function
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.
Autonomic control
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.
Oxidative stress
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.

Full Information

First Posted
March 14, 2011
Last Updated
March 10, 2015
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01325597
Brief Title
Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients
Official Title
Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Electric stimulation, Breathing exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined training
Arm Type
Experimental
Arm Description
Training with functional electrical stimulation added by inspiratory muscle training.
Arm Title
Electrical stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Other
Intervention Name(s)
Combined training
Other Intervention Name(s)
Electric stimulation, Electrical stimulation, Inspiratory muscle training, Breathing exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical stimulation
Other Intervention Name(s)
Electric stimulation, Eletric stimulation therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
Respiratory muscle training, Breathing exercises
Intervention Description
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Functional capacity
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life.
Time Frame
12 weeks
Title
Peripheral muscle strength
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.
Time Frame
12 weeks
Title
Pulmonary function
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.
Time Frame
12 weeks
Title
Respiratory muscle strength
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength.
Time Frame
12 weeks
Title
Endothelial function
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.
Time Frame
12 weeks
Title
Autonomic control
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.
Time Frame
12 weeks
Title
Oxidative stress
Description
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo DM Plentz, PhD
Phone
+ 55 51 91794399
Email
roplentz@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Graciele Sbruzzi, MSc
Phone
+ 55 51 98899705
Email
graci_sbruzzi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Organizational Affiliation
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90.620-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Phone
+ 55 51 32192802
Email
roplentz@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Graciele Sbruzzi, MSc
Phone
+ 55 51 32232746
Email
graci_sbruzzi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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