Interval Versus Continuous Training in Heart Failure

University of Sao Paulo

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Interval training; Behavioral: Continuous training

Study type: Interventional

Funder types: Other

Identifiers

NCT02448147

10/08990-1

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Interval training

Active Comparator group

Treatment:

Behavioral: Interval training

Continuous training

Active Comparator group

Treatment:

Behavioral: Continuous training

Control

No Intervention group