Heart FailureNCT02448147
Interval Versus Continuous Training in Heart Failure
A study testing Interval training and Continuous training in people with Heart Failure, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Interval training and Continuous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute - São Paulo University School of Medicine
São Paulo, São Paulo
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Interval training, Continuous training
- Keywords
- Heart failure, Exercise, Biomarkers, Sympathetic Nervous System, MicroRNA
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval trainingBehavioural
Also called Interval exercise training, Interval exercise
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 trainingBehavioural
Also called Continuous exercise training, Continuous exercise
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)
| Study group | Role | What they receive |
|---|---|---|
| Interval training | Active comparator | Not described Receives: Behavioral: Interval training |
| Continuous training | Active comparator | Not described Receives: Behavioral: Continuous training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular sympathetic nervous activity
Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.
Measured: 12 weeks
Peripheral muscular perfusion
Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.
Measured: 12 weeks
Biomarkers
Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).
Measured: 12 weeks
Secondary outcomes (2)
Daily life physical activity
Daily life physical activity determined by Baecke physical activity questionnaire and by a triaxial digital accelerometer during 24 hs.
Measured: 12 weeks
MicroRNA
Blood levels of selected microRNAs
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Guilherme Veiga Guimarães,, University of Sao Paulo
- Investigators
- Miguel MF Silva, MD, Study chair, Heart Institute (InCor) HC FMUSPGuilherme V Guimaraes, PhD, Principal investigator, Heart Institute (InCor) HC FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448147
- Sponsor's protocol ID
- 10/08990-1
- Status last verified
- May 2015
- First submitted
- 11 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28134562
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Training Versus Continuous Training on Peripheral Perfusion and Sympathetic Activity in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02448147
- Acronym / sponsor ID
- 10/08990-1
- Conditions
- Heart Failure
- Keywords
- Heart failure, Exercise, Biomarkers, Sympathetic Nervous System, MicroRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interval training | Active comparator | Behavioral: Interval training |
| Continuous training | Active comparator | Behavioral: Continuous training |
| Control | No intervention | – |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval trainingAlso: Interval exercise training, Interval exercisePatients 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. | Behavioural | Interval training |
| Continuous trainingAlso: Continuous exercise training, Continuous exercisePatients 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) | Behavioural | Continuous training |
Primary outcome
Muscular sympathetic nervous activity
Time frame: 12 weeks
Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.
Peripheral muscular perfusion
Time frame: 12 weeks
Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.
Biomarkers
Time frame: 12 weeks
Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).
2 secondary outcomes
Daily life physical activity
Time frame: 12 weeks
MicroRNA
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Derived from this study: PubMed 28134562Fernandes-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel MF Silva, MD study chair
Heart Institute (InCor) HC FMUSP
Guilherme V Guimaraes, PhD principal investigator
Heart Institute (InCor) HC FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval training and Continuous training in people with Heart Failure, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular sympathetic nervous activity (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.