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Completed

NCT Number: NCT02448147

Interval Versus Continuous Training in Heart Failure

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Motor Activity

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute - São Paulo University School of Medicine

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval Training

Behavioral

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.

Other names: Interval exercise training, Interval exercise

Continuous training

Behavioral

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)

Other names: Continuous exercise training, Continuous exercise

Primary outcomes

  1. Muscular sympathetic nervous activity

    Time frame: 12 weeks

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

  2. Peripheral muscular perfusion

    Time frame: 12 weeks

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

  3. 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

  1. Daily life physical activity

    Time frame: 12 weeks

    Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs.

  2. MicroRNA

    Time frame: 12 weeks

    Blood levels of selected microRNAs

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 19, 2015
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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