Coronary Artery DiseaseNCT02313831
Optimization of Interval Exercise Based-intensity on Ventilatory Anaerobic Threshold in Coronary Artery Disease
A study testing Interval training in people with Coronary Artery Disease and Cardiovascular Risk Factors, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Risk Factors
- What is being tested?
- Interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Dec 2015
- 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients will be undergone a medical investigation for coronary artery disease, by coronary angiography, at the Hemodynamics Center of local Hospital.
- After this procedure, the CAD+ group will include 34 patients, who will have clinical evidence significant stenosis (<50% of stenosis in one or more major coronary vessels), or previous coronary artery intervention (such as percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery).
- The CAD- group will be comprised 32 patients without stenosis in coronary vessels (angiographically documented) and without history of previous myocardial infarction (MI), PCI or CABG.
- All the patients will have three or more cardiovascular risk factors such as obesity (body mass index >30 kg/m2), smoking, sedentary lifestyle according to the International Physical Activity Questionnaire (IPAQ) version 6, hypertension, diabetes mellitus (type 2 - nonusers of insulin), and dyslipidemia.
Who cannot join
- The exclusion criteria consisted of MI <6 months, PCI and CABG <3 months
- Severe cardiac arrhythmias
- Chronic obstructive pulmonary disease
- Unstable angina
- Osteomuscular disorders
- Diabetes mellitus (users of insulin)
- Renal failure
- Sequelae associated with stroke.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Nayara Yamada Tamburús
São Carlos, São Paulo, 13.566-620
Nayara Y Tamburus, M.D., +5519998821224, nayaratamburus@hotmail.com
Ester Silva, PhD, +551633066705
About this study
Official title: Influence of Interval Aerobic Exercise Training on Cardiorespiratory and Metabolic Variables and Inflammatory Markers in Patients With Different Level of Coronary Artery Lesions
The purpose of this study is to investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.
Read the detailed description
Background: Exercise training has been essential component of the cardiac rehabilitation. However, it is not known if interval training based on ventilatory anaerobic threshold could be effective for improving aerobic functional capacity and metabolic profile.
Objective:To investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.
Design: Prospective randomized controlled trial. Subjects: 68 men between 40 and 65 years old.
All subjects will be submitted:
- - Clinical assessment: personal data, lifestyle and food, family history, current and previous history of disease.
- - Physical examination: cardiac and lung auscultation,measurement of heart rate, blood pressure, body weight and height.
- - Heart rate will be recorded at rest, in the supine position for 15 min, standing position for 10 min and respiratory sinus arrhythmia maneuver.
- - Submaximal or symptom-limited cardiopulmonary exercise test on cycle ergometer will be performed to determined the ventilatory anaerobic threshold.
- - Two cardiopulmonary exercise testing on treadmill at constant workload (moderate and high intensity). Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload.
- - Blood samples will be collected to analyze glycemic and lipid profiles.
- - After these procedures, the subjects will be randomly assigned to one of two groups, trained group or control group.
- - Interval training program will consist 30-40 minutes each exercise session, three times a week for 16 weeks, with a workload determined on the basis of ventilatory anaerobic threshold.
- - At 48 hours after the last day of training, the subjects will repeat all experimental procedures as in baseline testing. Controls will be retested 16 weeks after the completion of baseline testing.
- - All subjects will be instructed to maintain their habitual diet without a standardized caloric restriction.
Thus, it is expected that interval training will promote beneficial physiological adaptations in patients with and without coronary artery disease.
- Being tested
- Interval training
- Keywords
- autonomic nervous system, ventilatory anaerobic threshold, oxygen consumption, metabolic profile, exercise training, expiratory flow limitation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval trainingOther
Also called Cardiac rehabilitation
Patients of this group will be submitted to an interval training program
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Patients of this group will be submitted to an interval training Receives: Other: Interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of interval training
The IT intensity levels will be prescribed based on workload (W) attained at ventilatory anaerobic threshold, i. e., at 70%, 80%, 100% and 110%
Measured: 40 min
Secondary outcomes (4)
Aerobic functional capacity
Change in oxygen consumption at ventilatory anaerobic threshold will be assessed to compare changes on oxygen uptake at baseline and after a 16 weeks of interval training.
Measured: baseline and after interval training period (16 weeks)
Autonomic modulation of heart rate
Change in heart rate variability indices will be assessed to compare changes on cardiac parasympathetic and sympathetic modulations at baseline and after a 16 weeks of interval training.
Measured: baseline and after interval training period (16 weeks)
Metabolic profile
Change in glycemic and lipid profiles will be assessed to compare changes in metabolic profile at baseline and after a 16 weeks of interval training.
Measured: baseline and after interval training period (16 weeks)
Expiratory flow limitation
Investigate the mechanisms that limit expiratory airflow
Measured: Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayara Yamada Tamburús, Universidade Federal de Sao Carlos
- Investigators
- Ester d Silva, PhD, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313831
- Sponsor's protocol ID
- 34/2012
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tamburus NY, Verlengia R, Kunz VC, Cesar MC, Silva E. Apolipoprotein B and angiotensin-converting enzyme polymorphisms and aerobic interval training: randomized controlled trial in coronary artery disease patients. Braz J Med Biol Res. 2018;51(8):e6944. doi: 10.1590/1414-431x20186944. Epub 2018 May 28.
PubMed 29846435Tamburus NY, Kunz VC, Salviati MR, Castello Simoes V, Catai AM, Da Silva E. Interval training based on ventilatory anaerobic threshold improves aerobic functional capacity and metabolic profile: a randomized controlled trial in coronary artery disease patients. Eur J Phys Rehabil Med. 2016 Feb;52(1):1-11. Epub 2015 Jun 18.
PubMed 26086326
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Interval Aerobic Exercise Training on Cardiorespiratory and Metabolic Variables and Inflammatory Markers in Patients With Different Level of Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT02313831
- Acronym / sponsor ID
- 34/2012
- Keywords
- autonomic nervous system, ventilatory anaerobic threshold, oxygen consumption, metabolic profile, exercise training, expiratory flow limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Dec 2014 (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.
The purpose of this study is to investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.
Detailed description
Background: Exercise training has been essential component of the cardiac rehabilitation. However, it is not known if interval training based on ventilatory anaerobic threshold could be effective for improving aerobic functional capacity and metabolic profile.
Objective:To investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.
Design: Prospective randomized controlled trial. Subjects: 68 men between 40 and 65 years old.
All subjects will be submitted:
- - Clinical assessment: personal data, lifestyle and food, family history, current and previous history of disease.
- - Physical examination: cardiac and lung auscultation,measurement of heart rate, blood pressure, body weight and height.
- - Heart rate will be recorded at rest, in the supine position for 15 min, standing position for 10 min and respiratory sinus arrhythmia maneuver.
- - Submaximal or symptom-limited cardiopulmonary exercise test on cycle ergometer will be performed to determined the ventilatory anaerobic threshold.
- - Two cardiopulmonary exercise testing on treadmill at constant workload (moderate and high intensity). Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload.
- - Blood samples will be collected to analyze glycemic and lipid profiles.
- - After these procedures, the subjects will be randomly assigned to one of two groups, trained group or control group.
- - Interval training program will consist 30-40 minutes each exercise session, three times a week for 16 weeks, with a workload determined on the basis of ventilatory anaerobic threshold.
- - At 48 hours after the last day of training, the subjects will repeat all experimental procedures as in baseline testing. Controls will be retested 16 weeks after the completion of baseline testing.
- - All subjects will be instructed to maintain their habitual diet without a standardized caloric restriction.
Thus, it is expected that interval training will promote beneficial physiological adaptations in patients with and without coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Interval trainingPatients of this group will be submitted to an interval training |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients will be undergone a medical investigation for coronary artery disease, by coronary angiography, at the Hemodynamics Center of local Hospital.
- After this procedure, the CAD+ group will include 34 patients, who will have clinical evidence significant stenosis (<50% of stenosis in one or more major coronary vessels), or previous coronary artery intervention (such as percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery).
- The CAD- group will be comprised 32 patients without stenosis in coronary vessels (angiographically documented) and without history of previous myocardial infarction (MI), PCI or CABG.
- All the patients will have three or more cardiovascular risk factors such as obesity (body mass index >30 kg/m2), smoking, sedentary lifestyle according to the International Physical Activity Questionnaire (IPAQ) version 6, hypertension, diabetes mellitus (type 2 - nonusers of insulin), and dyslipidemia.
Key exclusion criteria (8 listed)
- The exclusion criteria consisted of MI <6 months, PCI and CABG <3 months
- Severe cardiac arrhythmias
- Chronic obstructive pulmonary disease
- Unstable angina
- Osteomuscular disorders
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: Cardiac rehabilitationPatients of this group will be submitted to an interval training program | Other | Exercise training |
Primary outcome
Intensity of interval training
Time frame: 40 min
The IT intensity levels will be prescribed based on workload (W) attained at ventilatory anaerobic threshold, i. e., at 70%, 80%, 100% and 110%
4 secondary outcomes
Aerobic functional capacity
Time frame: baseline and after interval training period (16 weeks)
Autonomic modulation of heart rate
Time frame: baseline and after interval training period (16 weeks)
Metabolic profile
Time frame: baseline and after interval training period (16 weeks)
Expiratory flow limitation
Time frame: Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Derived from this study: PubMed 29846435Tamburus NY, Verlengia R, Kunz VC, Cesar MC, Silva E. Apolipoprotein B and angiotensin-converting enzyme polymorphisms and aerobic interval training: randomized controlled trial in coronary artery disease patients. Braz J Med Biol Res. 2018;51(8):e6944. doi: 10.1590/1414-431x20186944. Epub 2018 May 28.
- Derived from this study: PubMed 26086326Tamburus NY, Kunz VC, Salviati MR, Castello Simoes V, Catai AM, Da Silva E. Interval training based on ventilatory anaerobic threshold improves aerobic functional capacity and metabolic profile: a randomized controlled trial in coronary artery disease patients. Eur J Phys Rehabil Med. 2016 Feb;52(1):1-11. Epub 2015 Jun 18.
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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.
Ester d Silva, PhD principal investigator
Universidade Federal de Sao Carlos
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 in people with Coronary Artery Disease and Cardiovascular Risk Factors, run by Universidade Federal de Sao Carlos 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nayara Y Tamburus, M.D. (+5519998821224, nayaratamburus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of interval training (time frame: 40 min). 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 NCT02313831, which also lists 2 linked publications.
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 16 Dec 2014.