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CompletedNCT02106533Updated Apr 8, 2014

Aerobic Exercise on Ventilatory Efficiency in CAD Patients

A Phase 2 interventional study of Aerobic exercise training in Coronary Artery Disease, Exercise Addiction and Complication, Cardio-respiratory, sponsored by Hospital TotalCor. Completed. Open to participants aged 48 Years to 77 Years. Per ClinicalTrials.gov, last updated 2014-04-08.

Sponsored by Hospital TotalCor · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
123
Allocation
Non-randomized
Ages
48 Years to 77 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Coronary artery disease
  • Exercise
  • Ventilatory efficiency
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 123 is close to the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Hospital TotalCor is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • was stable coronary artery disease diagnosed by coronary angiography

Exclusion criteria

Exclusion Criteria:

  • unstable angina pectoris,
  • complex ventricular arrhythmias,
  • pulmonary congestion and
  • orthopaedic or neurological limitations to exercise
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Group 1 peak VO2 <17.5 ml/kg/min

    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.

    Other: Aerobic exercise training

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

    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.

    Other: Aerobic exercise training

  • Experimental
    Group 3 peak VO2 > 24.5 ml/kg/min

    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.

    Other: Aerobic exercise training

Interventions

  • OtherAerobic exercise training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 3 months of the interventions

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25672429 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2011, a primary completion of Jun 2012 and a completion of May 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2014
First posted
Apr 8, 2014
Start
Aug 2011
Primary completionActual
Jun 2012
CompletionActual
May 2013
Last update
Apr 8, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02106533
Lead sponsor
Hospital TotalCor
Responsible party
Danilo Marcelo Leite do Prado (PHD, Hospital TotalCor) — Principal investigator
First posted
Apr 8, 2014
Start date
Aug 2011
Primary completion
Jun 2012
Completion
May 2013
Last update
Apr 8, 2014

Study contacts

Danilo ML Prado, PHD
principal investigator · Hospital TotalCor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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