- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02313831
Optimization of Interval Exercise Based-intensity on Ventilatory Anaerobic Threshold in Coronary Artery Disease
Influence of Interval Aerobic Exercise Training on Cardiorespiratory and Metabolic Variables and Inflammatory Markers in Patients With Different Level of Coronary Artery Lesions
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nayara Y Tamburus, M.D.
- Phone Number: +5519998821224
- Email: nayaratamburus@hotmail.com
Study Locations
-
-
São Paulo
-
São Carlos, São Paulo, Brazil, 13.566-620
- Recruiting
- Nayara Yamada Tamburús
-
Contact:
- Nayara Y Tamburus, M.D.
- Phone Number: +5519998821224
- Email: nayaratamburus@hotmail.com
-
Contact:
- Ester Silva, PhD
- Phone Number: +551633066705
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise training
Patients of this group will be submitted to an interval training
|
Patients of this group will be submitted to an interval training program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%
|
40 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic functional capacity
Time Frame: baseline and after interval training period (16 weeks)
|
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.
|
baseline and after interval training period (16 weeks)
|
Autonomic modulation of heart rate
Time Frame: baseline and after interval training period (16 weeks)
|
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.
|
baseline and after interval training period (16 weeks)
|
Metabolic profile
Time Frame: baseline and after interval training period (16 weeks)
|
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.
|
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
|
Investigate the mechanisms that limit expiratory airflow
|
Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ester d Silva, PhD, Universidade Federal de Sao Carlos
Publications and helpful links
General 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.
- Tamburus 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34/2012
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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