Interval Versus Continuous Training in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Continuous training; Behavioral: Interval training

• Registration Number: NCT02448147
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-05
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-14
• Last Update Submitted: 2015-05-14
• Study First Posted: 2015-05-19
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous training	Continuous training	-
Interval training	Interval training	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Daily life physical activity	12 weeks	Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs.
MicroRNA	12 weeks	Blood levels of selected microRNAs

Trial Locations

Locations (1)

Heart Institute - São Paulo University School of Medicine; 🇧🇷 São Paulo, SP, Brazil