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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02106533
Other study ID # 53/2010
Secondary ID
Status Completed
Phase Phase 2
First received March 27, 2014
Last updated April 7, 2014
Start date August 2011
Est. completion date May 2013

Study information

Verified date April 2014
Source Hospital TotalCor
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date May 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 48 Years to 77 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Aerobic 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital TotalCor

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 3 months of the interventions Yes
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