Interval Versus Continuous Training in Heart Failure

NCT ID: NCT02448147

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interval training

Group Type: ACTIVE_COMPARATOR

Interval training

Intervention Type: 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.

Continuous training

Group Type: ACTIVE_COMPARATOR

Continuous training

Intervention Type: 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)

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

Other Intervention Names

Interval exercise training; Interval exercise; Continuous exercise training; Continuous exercise

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Veiga Guimarães,

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel MF Silva, MD

Role: STUDY_CHAIR

Heart Institute (InCor) HC FMUSP

Guilherme V Guimaraes, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor) HC FMUSP

Locations

Heart Institute - São Paulo University School of Medicine

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28134562 (View on PubMed)

Other Identifiers

10/08990-1

Identifier Type: -

Identifier Source: org_study_id