- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02106533
Aerobic Exercise on Ventilatory Efficiency in CAD Patients
April 7, 2014 updated by: Danilo Marcelo Leite do Prado, Hospital TotalCor
Effect of Aerobic Exercise Training on Ventilatory Efficiency in Patients With Coronary Artery Disease
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Phase 2
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
48 years to 77 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventilatory efficiency in patients with coronary artery disease
Time Frame: up to 3 months of the interventions
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danilo ML Prado, PHD, Hospital TotalCor
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, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 27, 2014
First Submitted That Met QC Criteria
April 7, 2014
First Posted (Estimate)
April 8, 2014
Study Record Updates
Last Update Posted (Estimate)
April 8, 2014
Last Update Submitted That Met QC Criteria
April 7, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 53/2010
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.