Clinical trial NCT02448147: Interval Versus Continuous Training in Heart Failure
Official title: Interval Training Versus Continuous Training on Peripheral Perfusion and Sympathetic Activity in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Exercise
Biomarkers
Sympathetic Nervous System
MicroRNA
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Muscular sympathetic nervous activity
timeFrame: 12 weeks
measure: Peripheral muscular perfusion
timeFrame: 12 weeks
measure: Biomarkers
timeFrame: 12 weeks
Secondary outcomes:
measure: Daily life physical activity
timeFrame: 12 weeks
measure: MicroRNA
timeFrame: 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute - São Paulo University School of Medicine
state: SP
Study officials:
affiliation: Heart Institute (InCor) HC FMUSP
name: Miguel MF Silva, MD
role: STUDY_CHAIR
affiliation: Heart Institute (InCor) HC FMUSP
name: Guilherme V Guimaraes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.