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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Combined training
* Other: Electrical stimulation
* Other: Inspiratory muscle training
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined training<br>Training with functional electrical stimulation added by inspiratory muscle training. | Other: Electrical stimulation<br>* 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<br>* Other names: Eletric stimulation therapy;Other: Inspiratory muscle training<br>* IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure<br>* Other names: Breathing exercises;Other: Control group<br>* No intervention<br>|
| Experimental: Electrical stimulation<br>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<br>* 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.<br>* Other names: Breathing exercises;Other: Inspiratory muscle training<br>* IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure<br>* Other names: Breathing exercises;Other: Control group<br>* No intervention<br>|
| Experimental: Inspiratory muscle training<br>IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure | Other: Combined training<br>* 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.<br>* Other names: Breathing exercises;Other: Electrical stimulation<br>* 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<br>* Other names: Eletric stimulation therapy;Other: Control group<br>* No intervention<br>|
| No Intervention: Control group<br>No intervention. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Electric stimulation, Breathing exercises