Interval Versus Continuous Training in Heart Failure

Study Overview
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Brief Summary
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BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle disability and exercise intolerance. The interval exercise training has been proposed as one efficient method to heart failure patients. It seems that the main mechanism involved in the benefit of the interval exercise training is shear stress. AIM: To study the interval exercise training versus the continuous exercise training in the sympathetic activity and in the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation, quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and female) with age between 30 and 60 years, left ventricular ejection fraction less than 40% and functional class I, II and III. These patients will be randomized into three groups: Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer, cardiopulmonary exercise test and quality of life before and after end of the period of 03 (three) months.

Official Title
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Interval Training Versus Continuous Training on Peripheral Perfusion and Sympathetic Activity in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Interval training
* Behavioral: Continuous training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable chronic heart failure without changing in treatment for at least 6 weeks ejection fraction less then 40%, as measured by transthoracic echocardiography optimal clinical treatment for chronic heart failure according to current guidelines. Exclusion Criteria: asthma or chronic obstructive pulmonary disease using inhaled corticosteroids functional class IV (New York Heart Association - NYHA) atrial fibrillation complex ventricular arrhythmia pacemaker or implantable cardioversor/defibrillators chronic renal insufficiency, defined as serum creatinine above 2,5 mg/dL intermittent claudication morbid obesity cirrhosis alcoholism using illicit drugs performing regular physical activity participating in another study invasive procedure planned persistent nonadherence to therapeutic regimen peak respiratory exchange ratio (RER) lower than 1.00

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interval training<br> | Behavioral: Interval training<br>* Patients will be submitted to three months aerobic exercise training, three times per week. Each session will have two levels of intensity: one minute at respiratory compensation point heart rate intercalating with two minutes at anaerobic threshold heart rate during thirty minutes.<br>* Other names: Interval exercise;|
| Active Comparator: Continuous training<br> | Behavioral: Continuous training<br>* Patients will be submitted to three months aerobic exercise training, three times per week. Each session will have only one level of intensity during stimulus phase of exercise, lasting thirty minutes: heart rate (HR) target is defined as 1/3x(HR at respiratory compensation point) + 2/3x(HR anaerobic threshold)<br>* Other names: Continuous exercise;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular sympathetic nervous activity | Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography. | 12 weeks | 
| Peripheral muscular perfusion | Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise. | 12 weeks | 
| Biomarkers | Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily life physical activity | Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs. | 12 weeks | 
| MicroRNA | Blood levels of selected microRNAs | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sympathetic Nervous System, MicroRNA, Heart failure, Exercise, Biomarkers