Interval Versus Continuous Training in Heart Failure

May 14, 2015 updated by: Guilherme Veiga Guimarães,, University of Sao Paulo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Heart Institute - São Paulo University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Interval training
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.
Other Names:
  • Interval exercise training
  • Interval exercise
Active Comparator: Continuous training
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)
Other Names:
  • Continuous exercise training
  • Continuous exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular sympathetic nervous activity
Time Frame: 12 weeks
Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.
12 weeks
Peripheral muscular perfusion
Time Frame: 12 weeks
Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.
12 weeks
Biomarkers
Time Frame: 12 weeks
Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
MicroRNA
Time Frame: 12 weeks
Blood levels of selected microRNAs
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Guilherme V Guimaraes, PhD, Heart Institute (InCor) HC FMUSP
  • Study Chair: Miguel MF Silva, MD, Heart Institute (InCor) HC FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/08990-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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