Heart Failure
Conditions
Keywords
Heart failure, Electric stimulation, Breathing exercises
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.
Interventions
OTHERCombined 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. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
OTHERElectrical stimulation
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
OTHERInspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
OTHERControl group
No intervention
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Instituto de Cardiologia do Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity | 12 weeks | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic control | 12 weeks | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control. |
| 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. |
| 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. |
| Endothelial function | 12 weeks | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function. |
| 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. |
| Oxidative stress | 12 weeks | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress. |
| Pulmonary function | 12 weeks | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function. |
Countries
Brazil
Contacts
Primary ContactRodrigo DM Plentz, PhD
Backup ContactGraciele Sbruzzi, MSc
Outcome results
None listed