Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Functional capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Functional capacity
Time Frame: 12 weeks
To assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity.
Secondary Outcomes
- Peripheral muscle strength(12 weeks)
- Pulmonary function(12 weeks)
- Oxidative stress(12 weeks)
- Quality of life(12 weeks)
- Respiratory muscle strength(12 weeks)
- Endothelial function(12 weeks)
- Autonomic control(12 weeks)
Investigators
Graciele Sbruzzi
Doutora
Instituto de Cardiologia do Rio Grande do Sul