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Aerobic Exercise on Ventilatory Efficiency in CAD Patients

Primary Purpose

Coronary Artery Disease, Exercise Addiction, Complication, Cardio-respiratory

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aerobic exercise training
Sponsored by
Hospital TotalCor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Exercise, Ventilatory efficiency

Eligibility Criteria

48 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • was stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

  • unstable angina pectoris,
  • complex ventricular arrhythmias,
  • pulmonary congestion and
  • orthopaedic or neurological limitations to exercise

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1 peak VO2 <17.5 ml/kg/min

    Group 2 peak VO2 > 17.5 < 24.5 ml/kg/min

    Group 3 peak VO2 > 24.5 ml/kg/min

    Arm Description

    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP.

    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.

    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill . Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.

    Outcomes

    Primary Outcome Measures

    Ventilatory efficiency in patients with coronary artery disease
    Measurements of ventilatory efficiency during cardiopulmonary exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2014
    Last Updated
    April 7, 2014
    Sponsor
    Hospital TotalCor
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02106533
    Brief Title
    Aerobic Exercise on Ventilatory Efficiency in CAD Patients
    Official Title
    Effect of Aerobic Exercise Training on Ventilatory Efficiency in Patients With Coronary Artery Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital TotalCor

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the present study was to test the hypothesis that patients with coronary artery disease with lower aerobic fitness exhibit greater responsiveness on improving ventilatory efficiency after aerobic exercise training.
    Detailed Description
    Measurements of ventilatory efficiency during cardiorespiratory exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs. In addition, a growing body of studies has demonstrated that lower ventilatory efficiency during exercise is considered an important predictor of risk mortality, hospitalization, and other outcomes than peak VO2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Exercise Addiction, Complication, Cardio-respiratory
    Keywords
    Coronary artery disease, Exercise, Ventilatory efficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    123 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 peak VO2 <17.5 ml/kg/min
    Arm Type
    Experimental
    Arm Description
    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP.
    Arm Title
    Group 2 peak VO2 > 17.5 < 24.5 ml/kg/min
    Arm Type
    Experimental
    Arm Description
    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.
    Arm Title
    Group 3 peak VO2 > 24.5 ml/kg/min
    Arm Type
    Experimental
    Arm Description
    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill . Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic exercise training
    Intervention Description
    The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.
    Primary Outcome Measure Information:
    Title
    Ventilatory efficiency in patients with coronary artery disease
    Description
    Measurements of ventilatory efficiency during cardiopulmonary exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs.
    Time Frame
    up to 3 months of the interventions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    48 Years
    Maximum Age & Unit of Time
    77 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: was stable coronary artery disease diagnosed by coronary angiography Exclusion Criteria: unstable angina pectoris, complex ventricular arrhythmias, pulmonary congestion and orthopaedic or neurological limitations to exercise
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danilo ML Prado, PHD
    Organizational Affiliation
    Hospital TotalCor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25672429
    Citation
    Prado DM, Rocco EA, Silva AG, Silva PF, Lazzari JM, Assumpcao GL, Thies SB, Suzaki CY, Puig RS, Furlan V. The influence of aerobic fitness status on ventilatory efficiency in patients with coronary artery disease. Clinics (Sao Paulo). 2015 Jan;70(1):46-51. doi: 10.6061/clinics/2015(01)09.
    Results Reference
    derived

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    Aerobic Exercise on Ventilatory Efficiency in CAD Patients

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