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

Heart Failure Clinical Trial

Official title:

Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01325597
• Other study ID #: UP 4546/10
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2011
• Last updated: March 10, 2015
• Start date: March 2010
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Rodrigo DM Plentz, PhD
• Phone: + 55 51 91794399
• Email: roplentz[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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
• Inspiratory muscle training
IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
• Control group
No intervention

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.	12 weeks	Yes
Secondary	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	Yes
Secondary	Peripheral muscle strength	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on peripheral muscle strength.	12 weeks	Yes
Secondary	Pulmonary function	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on pulmonary function.	12 weeks	Yes
Secondary	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	Yes
Secondary	Endothelial function	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on endothelial function.	12 weeks	Yes
Secondary	Autonomic control	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on autonomic control.	12 weeks	Yes
Secondary	Oxidative stress	To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on oxidative stress.	12 weeks	Yes