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Clinical Trials/NCT02313831
NCT02313831
Unknown
Not Applicable

Influence of Interval Aerobic Exercise Training on Cardiorespiratory and Metabolic Variables and Inflammatory Markers in Patients With Different Level of Coronary Artery Lesions

Universidade Federal de Sao Carlos1 site in 1 country68 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Universidade Federal de Sao Carlos
Enrollment
68
Locations
1
Primary Endpoint
Intensity of interval training
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Universidade Federal de Sao Carlos
Responsible Party
Principal Investigator
Principal Investigator

Nayara Yamada Tamburús

M.D.

Universidade Federal de Sao Carlos

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.

Outcomes

Primary Outcomes

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%

Secondary Outcomes

  • Aerobic functional capacity(baseline and after interval training period (16 weeks))
  • Metabolic profile(baseline and after interval training period (16 weeks))
  • Expiratory flow limitation(Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload)
  • Autonomic modulation of heart rate(baseline and after interval training period (16 weeks))

Study Sites (1)

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