Coronary Artery DiseasePhase 2NCT01515033
Aerobic Exercise on PETCO2 Response in Coronary Artery Disease Patients
A Phase 2 study testing aerobic exercise training in people with Coronary Artery Disease and Exercise Addiction, run by Hospital TotalCor.
Trial summary
The purpose of the present study was to evaluate: 1) the effects of continuous exercise training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2) response during graded exercise test in patients with coronary artery disease; and 2) examine the effects of exercise training modalities on the… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Coronary Artery Disease, Exercise Addiction, Complication, Cardio-respiratory
- What is being tested?
- aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- was stable coronary artery disease diagnosed by coronary angiography
Who cannot join
- unstable angina pectoris,
- complex ventricular arrhythmias,
- pulmonary congestion and
- orthopaedic or neurological limitations to exercise
About this study
Official title: Effect of Continuous and Interval Exercise Training on PETCO2 Response During Graded Exercise Test in Patients With Coronary Artery Disease
The purpose of the present study was to evaluate: 1) the effects of continuous exercise training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2) response during graded exercise test in patients with coronary artery disease; and 2) examine the effects of exercise training modalities on the association among PETCO2 at ventilatory anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory fitness in patients with coronary artery disease.
Read the detailed description
End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good indicator in evaluating the ventilation/perfusion relationship in patients over a wide range conditions. Variations in PETCO2 have been shown to reflect changes in both cardiac output and pulmonary blood flow in animals and humans under constant ventilation. In this regard, it has been shown that patients with cardiac disease have an abnormally low PETCO2 during exercise, especially those with an impaired response of cardiac output during exercise
- Being tested
- aerobic exercise training
- Keywords
- Coronary artery disease, Exercise, Ventilatory efficiency
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise trainingOther
Also called continuous training, interval training
The continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold.
The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes
| Study group | Role | What they receive |
|---|---|---|
| Continuous exercise training | Experimental | The continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold. Receives: Other: aerobic exercise training |
| interval exercise training | Experimental | The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes Receives: Other: aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PetCO2 response during graded exercise test
End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good indicator in evaluating the ventilation/perfusion relationship in patients over a wide range conditions (1,2). Variations in PETCO2 have been shown to reflect changes in both cardiac output and pulmonary blood flow in animals and humans under constant ventilation
Measured: before and after 3 months of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital TotalCor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danilo Marcelo Leite do Prado, Hospital TotalCor
- Investigators
- Danilo ML Prado, Prof.MS, Principal investigator, Hospital TotalCor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515033
- Sponsor's protocol ID
- 117/11
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous and Interval Exercise Training on PETCO2 Response During Graded Exercise Test in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01515033
- Acronym / sponsor ID
- 117/11
- Keywords
- Coronary artery disease, Exercise, Ventilatory efficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital TotalCorUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study was to evaluate: 1) the effects of continuous exercise training and interval exercise training on end-tidal carbon dioxide pressure (PETCO2) response during graded exercise test in patients with coronary artery disease; and 2) examine the effects of exercise training modalities on the association among PETCO2 at ventilatory anaerobic threshold (VAT) and indicators of ventilatory efficiency and cardiorespiratory fitness in patients with coronary artery disease.
Detailed description
End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good indicator in evaluating the ventilation/perfusion relationship in patients over a wide range conditions. Variations in PETCO2 have been shown to reflect changes in both cardiac output and pulmonary blood flow in animals and humans under constant ventilation. In this regard, it has been shown that patients with cardiac disease have an abnormally low PETCO2 during exercise, especially those with an impaired response of cardiac output during exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous exercise training | Experimental | Other: aerobic exercise trainingThe continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold. |
| interval exercise training | Experimental | Other: aerobic exercise trainingThe interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- was stable coronary artery disease diagnosed by coronary angiography
Key exclusion criteria (4 listed)
- unstable angina pectoris,
- complex ventricular arrhythmias,
- pulmonary congestion and
- orthopaedic or neurological limitations to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise trainingAlso: continuous training, interval trainingThe continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold. The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes | Other | Continuous exercise training, interval exercise training |
Primary outcome
PetCO2 response during graded exercise test
Time frame: before and after 3 months of the interventions
End-tidal carbon dioxide pressure (PETCO2) is a noninvasive index considered to be a good indicator in evaluating the ventilation/perfusion relationship in patients over a wide range conditions (1,2). Variations in PETCO2 have been shown to reflect changes in both cardiac output and pulmonary blood flow in animals and humans under constant ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danilo ML Prado, Prof.MS principal investigator
Hospital TotalCor
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aerobic exercise training in people with Coronary Artery Disease and Exercise Addiction, run by Hospital TotalCor.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PetCO2 response during graded exercise test (time frame: before and after 3 months of the interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.