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Clinical Trials/NCT02448147
NCT02448147
Completed
Not Applicable

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

University of Sao Paulo1 site in 1 country40 target enrollmentMay 2011
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Sao Paulo
Enrollment
40
Locations
1
Primary Endpoint
Muscular sympathetic nervous activity
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
April 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guilherme Veiga Guimarães,

Principal Investigator

University of Sao Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Muscular sympathetic nervous activity

Time Frame: 12 weeks

Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.

Peripheral muscular perfusion

Time Frame: 12 weeks

Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.

Biomarkers

Time Frame: 12 weeks

Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).

Secondary Outcomes

  • Daily life physical activity(12 weeks)
  • MicroRNA(12 weeks)

Study Sites (1)

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