Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combined training Training with functional electrical stimulation added by inspiratory muscle training. |
Other: Electrical 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
Other Names:
Other: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Other Names:
Other: Control group
No intervention
|
| Experimental: Electrical 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 |
Other: Combined 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.
Other Names:
Other: Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
Other Names:
Other: Control group
No intervention
|
| Experimental: Inspiratory muscle training IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure |
Other: Combined 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.
Other Names:
Other: Electrical 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
Other Names:
Other: Control group
No intervention
|
| No Intervention: Control group No intervention. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Pulmonary function [12 weeks]
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary 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.
- 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.
- Oxidative stress [12 weeks]
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia | Porto Alegre | Rio Grande do Sul | Brazil | 90.620-000 |
Sponsors and Collaborators
- Instituto de Cardiologia do Rio Grande do Sul
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
- Principal Investigator: Rodrigo DM Plentz, PhD, Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UP 4546/10