Interval Versus Continuous Training in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448147
• Other study ID #: 10/08990-1
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: May 14, 2015
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Interval training
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.
• Continuous training
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)

Locations

Country	Name	City	State
Brazil	Heart Institute - São Paulo University School of Medicine	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular sympathetic nervous activity	Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.	12 weeks	No
Primary	Peripheral muscular perfusion	Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.	12 weeks	No
Primary	Biomarkers	Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).	12 weeks	No
Secondary	Daily life physical activity	Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs.	12 weeks	No
Secondary	MicroRNA	Blood levels of selected microRNAs	12 weeks	No