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

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT01325597
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11
• Primary Completion: 2016-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional capacity	12 weeks	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil