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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined training | Experimental | Training with functional electrical stimulation added by inspiratory muscle training. |
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| Electrical stimulation | Experimental | 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 |
|
| Inspiratory muscle training | Experimental | IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure |
|
| Control group | No Intervention | No intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on quality of life. | 12 weeks |
| Peripheral muscle strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo DM Plentz, PhD | Contact | + 55 51 91794399 | roplentz@yahoo.com.br | |
| Graciele Sbruzzi, MSc | Contact | + 55 51 98899705 | graci_sbruzzi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo DM Plentz, PhD | Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia | Recruiting | Porto Alegre | Rio Grande do Sul | 90.620-000 | Brazil |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D001945 | Breathing Exercises |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
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|
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| Electrical stimulation | Other | 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 |
|
|
| Inspiratory muscle training | Other | IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure |
|
|
| Control group | Other | No intervention |
|
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.
| 12 weeks |
| Pulmonary function | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function. | 12 weeks |
| Respiratory muscle strength | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on respiratory muscle strength. | 12 weeks |
| Endothelial function | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function. | 12 weeks |
| Autonomic control | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control. | 12 weeks |
| Oxidative stress | To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress. | 12 weeks |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D012107 | Research Design |
| D008722 | Methods |