Interval Versus Continuous Training in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Interval training
Continuous training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Exercise, Biomarkers, Sympathetic Nervous System, MicroRNA
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
Sites / Locations
- Heart Institute - São Paulo University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Interval training
Continuous training
Control
Arm Description
Outcomes
Primary Outcome Measures
Muscular sympathetic nervous activity
Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.
Peripheral muscular perfusion
Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.
Biomarkers
Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).
Secondary Outcome Measures
Daily life physical activity
Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs.
MicroRNA
Blood levels of selected microRNAs
Full Information
NCT ID
NCT02448147
First Posted
May 11, 2015
Last Updated
May 14, 2015
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02448147
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Exercise, Biomarkers, Sympathetic Nervous System, MicroRNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interval training
Arm Type
Active Comparator
Arm Title
Continuous training
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Interval training
Other Intervention Name(s)
Interval exercise training, Interval exercise
Intervention Description
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
Intervention Name(s)
Continuous training
Other Intervention Name(s)
Continuous exercise training, Continuous exercise
Intervention Description
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)
Primary Outcome Measure Information:
Title
Muscular sympathetic nervous activity
Description
Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.
Time Frame
12 weeks
Title
Peripheral muscular perfusion
Description
Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.
Time Frame
12 weeks
Title
Biomarkers
Description
Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Daily life physical activity
Description
Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs.
Time Frame
12 weeks
Title
MicroRNA
Description
Blood levels of selected microRNAs
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel MF Silva, MD
Organizational Affiliation
Heart Institute (InCor) HC FMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guilherme V Guimaraes, PhD
Organizational Affiliation
Heart Institute (InCor) HC FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute - São Paulo University School of Medicine
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
28134562
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.
Results Reference
derived
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Interval Versus Continuous Training in Heart Failure
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