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Optimization of Interval Exercise Based-intensity on Ventilatory Anaerobic Threshold in Coronary Artery Disease

Primary Purpose

Coronary Artery Disease, Cardiovascular Risk Factors

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Interval training
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring autonomic nervous system, ventilatory anaerobic threshold, oxygen consumption, metabolic profile, exercise training, expiratory flow limitation

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Nayara Yamada TamburúsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise training

Arm Description

Patients of this group will be submitted to an interval training

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

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.
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.
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.
Expiratory flow limitation
Investigate the mechanisms that limit expiratory airflow

Full Information

First Posted
December 8, 2014
Last Updated
December 13, 2014
Sponsor
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02313831
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cardiovascular Risk Factors
Keywords
autonomic nervous system, ventilatory anaerobic threshold, oxygen consumption, metabolic profile, exercise training, expiratory flow limitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Patients of this group will be submitted to an interval training
Intervention Type
Other
Intervention Name(s)
Interval training
Other Intervention Name(s)
Cardiac rehabilitation
Intervention Description
Patients of this group will be submitted to an interval training program
Primary Outcome Measure Information:
Title
Intensity of interval training
Description
The IT intensity levels will be prescribed based on workload (W) attained at ventilatory anaerobic threshold, i. e., at 70%, 80%, 100% and 110%
Time Frame
40 min
Secondary Outcome Measure Information:
Title
Aerobic functional capacity
Description
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.
Time Frame
baseline and after interval training period (16 weeks)
Title
Autonomic modulation of heart rate
Description
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.
Time Frame
baseline and after interval training period (16 weeks)
Title
Metabolic profile
Description
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.
Time Frame
baseline and after interval training period (16 weeks)
Title
Expiratory flow limitation
Description
Investigate the mechanisms that limit expiratory airflow
Time Frame
Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nayara Y Tamburus, M.D.
Phone
+5519998821224
Email
nayaratamburus@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester d Silva, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nayara Yamada Tamburús
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13.566-620
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayara Y Tamburus, M.D.
Phone
+5519998821224
Email
nayaratamburus@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ester Silva, PhD
Phone
+551633066705

12. IPD Sharing Statement

Citations:
PubMed Identifier
29846435
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.
Results Reference
derived
PubMed Identifier
26086326
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.
Results Reference
derived

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Optimization of Interval Exercise Based-intensity on Ventilatory Anaerobic Threshold in Coronary Artery Disease

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