Clinical trial NCT01325597: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Electric stimulation
Breathing exercises
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 12 weeks
measure: Peripheral muscle strength
timeFrame: 12 weeks
measure: Pulmonary function
timeFrame: 12 weeks
measure: Respiratory muscle strength
timeFrame: 12 weeks
measure: Endothelial function
timeFrame: 12 weeks
measure: Autonomic control
timeFrame: 12 weeks
measure: Oxidative stress
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
state: Rio Grande do Sul
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
name: Rodrigo DM Plentz, PhD
role: PRINCIPAL_INVESTIGATOR
References: