Interval Versus Continuous Training in Heart Failure

NCT02448147 | Completed DMC

• 1 other identifier: 10/08990-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Exercise; Biomarkers; Sympathetic Nervous System; MicroRNA

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Daily life physical activity

  12 weeks

• MicroRNA

  12 weeks

Study Arms (3)

Interval training

ACTIVE COMPARATOR

Behavioral: Interval training

Continuous training

ACTIVE COMPARATOR

Behavioral: Continuous training

Control

NO INTERVENTION

Interventions

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.

Also known as: Interval exercise training, Interval exercise

Interval training

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)

Also known as: Continuous exercise training, Continuous exercise

Continuous training

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Institute - São Paulo University School of Medicine

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• Fernandes-Silva MM, Guimaraes GV, Rigaud VO, Lofrano-Alves MS, Castro RE, de Barros Cruz LG, Bocchi EA, Bacal F. Inflammatory biomarkers and effect of exercise on functional capacity in patients with heart failure: Insights from a randomized clinical trial. Eur J Prev Cardiol. 2017 May;24(8):808-817. doi: 10.1177/2047487317690458. Epub 2017 Jan 30.

  PMID: 28134562 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Miguel MF Silva, MD

  Heart Institute (InCor) HC FMUSP

  STUDY CHAIR

• Guilherme V Guimaraes, PhD

  Heart Institute (InCor) HC FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 19, 2015
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

BR (1)