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

December 13, 2014 updated by: Nayara Yamada Tamburús, Universidade Federal de Sao Carlos

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.

Study Overview

Status

Unknown

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • São Paulo
      • São Carlos, São Paulo, Brazil, 13.566-620
        • Recruiting
        • Nayara Yamada Tamburús
        • Contact:
        • Contact:
          • Ester Silva, PhD
          • Phone Number: +551633066705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Cardiac rehabilitation

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ester d Silva, PhD, Universidade Federal de Sao Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 13, 2014

Last Verified

December 1, 2014

More Information

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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