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

Instituto de Cardiologia do Rio Grande do Sul

Status: Unknown

Conditions: Heart Failure

Treatments: Other: Control group; Other: Inspiratory muscle training; Other: Electrical stimulation; Other: Combined training

Study type: Interventional

Funder types: Other

Identifiers

NCT01325597

UP 4546/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Combined training

Experimental group

Description:

Training with functional electrical stimulation added by inspiratory muscle training.

Treatment:

Other: Control group

Other: Electrical stimulation

Other: Inspiratory muscle training

Electrical stimulation

Experimental group

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

Treatment:

Other: Control group

Other: Combined training

Other: Inspiratory muscle training

Inspiratory muscle training

Experimental group

Description:

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

Treatment:

Other: Control group

Other: Electrical stimulation

Other: Combined training

Control group

No Intervention group

Description:

No intervention.