Clinical trial NCT02313831: Optimization of Interval Exercise Based-intensity on Ventilatory Anaerobic Threshold in Coronary Artery Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Risk Factors
Keywords: autonomic nervous system
ventilatory anaerobic threshold
oxygen consumption
metabolic profile
exercise training
expiratory flow limitation
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 68
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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:

1. - Clinical assessment: personal data, lifestyle and food, family history, current and previous history of disease.
2. - Physical examination: cardiac and lung auscultation,measurement of heart rate, blood pressure, body weight and height.
3. - Heart rate will be recorded at rest, in the supine position for 15 min, standing position for 10 min and respiratory sinus arrhythmia maneuver.
4. - Submaximal or symptom-limited cardiopulmonary exercise test on cycle ergometer will be performed to determined the ventilatory anaerobic threshold.
5. - 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.
6. - Blood samples will be collected to analyze glycemic and lipid profiles.
7. - After these procedures, the subjects will be randomly assigned to one of two groups, trained group or control group.
8. - 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.
9. - 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.
10. - 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of interval training
timeFrame: 40 min
Secondary outcomes:
measure: Aerobic functional capacity
timeFrame: baseline and after interval training period (16 weeks)
measure: Autonomic modulation of heart rate
timeFrame: baseline and after interval training period (16 weeks)
measure: Metabolic profile
timeFrame: baseline and after interval training period (16 weeks)
measure: Expiratory flow limitation
timeFrame: Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Nayara Yamada Tamburús
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Ester d Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.