Acute Coronary SyndromeFRAXIONCT00754533
Continuous Versus Interval Training in Patients With Coronary Artery Disease: FRAXIO Study
A study testing Continuous versus interval training in people with Acute Coronary Syndrome, run by University Hospital, Limoges at 2 sites in France.
Trial summary
The benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise training is recognized to be part of modern management after coronary artery disease. However methods of prescribing exercise-training programs and the exercise intensity are difficult to determine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Continuous versus interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2008to Sep 2010
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patient hospitalized at Limoges University Hospital, cardiology department, for acute coronary syndrome:
- with or without ST segment elevation
- with or without elevated troponin
- with or without revascularization
- Patients stabilized with medication without rest myocardial ischemia
Show all 9Show fewer
- Left ventricular ejection fraction >= 35% measured on echocardiography
- Patient who have signed and dated informed consent
- Patient who can do a maximal metabolic exercise test
Who cannot join
- Contraindication for exercise testing:
- acute myocardial infraction < 5 days
- unstable angina
- left main coronary stenosis
- uncontrolled cardiac arrhythmia
- uncontrolled symptomatic heart failure
Show all 21Show fewer
- acute pulmonary embolism or phlebitis
- acute myocarditis, pericarditis or endocarditis
- patient's physical inability or refusal
- left ventricular thrombus after acute myocardial infarction
- pulmonary hypertension > 60 mmHg
- uncontrolled arterial hypertension
- Age < 18 years
- Patient revascularized by coronary artery bypass grafting after acute coronary syndrome
- Chronic supraventricular arrhythmias
- Impossible physical exercise
- Patient who can't understand the protocol or who refused to give his consent
- Patient who already attended a training program over the last 6 months
- Patient with difficult follow-up
- Current participation in another study
- Patient under guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cardiology
Limoges, 87
Explorations Fonctionnelles Physiologiques
Limoges, 87
About this study
Official title: Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters
The benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise training is recognized to be part of modern management after coronary artery disease. However methods of prescribing exercise-training programs and the exercise intensity are difficult to determine. The objective of this randomised clinical trial is to determine whether appropriate endurance exercise training improves the ventilatory threshold, the exercise tolerance and the quality of life in patients with coronary artery disease. Patients are randomized to continuous training or aerobic interval training respectively: 80%-versus maximal-workload at the ventilatory threshold. For each patient, the intensity of exercise training is determined by a first exercise test with gas analysis using parameters of sub maximal exercise capacity such as ventilatory threshold. Others parameters of functional capacity are also considered. Duration of the rehabilitation stage is between 7 to 10 weeks. Dyspnoea assessment at maximal intensity, quality of life measurement by SF36, drugs and events are reported. Maximal exercise tests with gas exchange measurements are performed after training program and at 6 months follow-up to compare the different cardio respiratory parameters in the two groups before and after exercise training and to evaluate the more effective endurance training program.
Read the detailed description
- Outline of the training program: Duration of the rehabilitation course is 7 or 10 weeks, 2 or 3 training sessions a week, 21 sessions altogether. Each training session consist in cycling on an ergometer. In the interval training group, the training session alternates one minute at 100% workload at the ventilatory threshold and one minute active pause at 50% workload at the ventilatory threshold; total exercise time is 20 minutes. In continuous training, the training session lasts 20 minutes at 80% workload at the ventilatory threshold.
- Exercise testing: Exercise capacity is measured before and at the end of the exercise training program and at 6 month follow-up. A first exercise test with respiratory gas exchange is performed 2 weeks after hospitalization: this is the baseline exercise test. The protocol consists of 3-min warm up at a workload of 30 watts. At each stage, the workload is increased by 10 or 15 watts per min. Patients are instructed to maintain a speed of 55 to 65 rotations per min. Four exercise tests with gas analysis are programmed during cardiac rehabilitation: three maximal tests (before exercise training program to precise exercise intensity during the sessions, after training program to evaluate the primary end point and at 6 months) and one sub maximal exercise test during the tenth session to adjust the intensity of training exercises (this test is stopped when the ventilatory threshold is obtained).
- Conditions
- Acute Coronary Syndrome
- Being tested
- Continuous versus interval training
- Keywords
- cardiac rehabilitation, coronary heart disease, interval training, continuous training, ventilatory threshold
- Medical subject headings
- Acute Coronary Syndrome, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous versus interval trainingOther
Influence of different exercise training programs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Continuous training Receives: Other: Continuous versus interval training |
| 2 | Other | Interval training Receives: Other: Continuous versus interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to compare the effect on ventilatory threshold before and after cardiac rehabilitation in the continuous training group versus interval training group
Measured: 6 month
Secondary outcomes (1)
The secondary endpoint is to compare the effect on ventilatory threshold before and at 6 month after cardiac rehabilitation in the two groups
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Prisca DEMAISON, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754533
- Sponsor's protocol ID
- I08005
- Acronym
- FRAXIO
- Status last verified
- Oct 2008
- First submitted
- 17 Sep 2008
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters
- ClinicalTrials.gov ID
- NCT00754533
- Acronym / sponsor ID
- FRAXIO / I08005
- Conditions
- Acute Coronary Syndrome
- Keywords
- cardiac rehabilitation, coronary heart disease, interval training, continuous training, ventilatory threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Sep 2008 (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 benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise training is recognized to be part of modern management after coronary artery disease. However methods of prescribing exercise-training programs and the exercise intensity are difficult to determine. The objective of this randomised clinical trial is to determine whether appropriate endurance exercise training improves the ventilatory threshold, the exercise tolerance and the quality of life in patients with coronary artery disease. Patients are randomized to continuous training or aerobic interval training respectively: 80%-versus maximal-workload at the ventilatory threshold. For each patient, the intensity of exercise training is determined by a first exercise test with gas analysis using parameters of sub maximal exercise capacity such as ventilatory threshold. Others parameters of functional capacity are also considered. Duration of the rehabilitation stage is between 7 to 10 weeks. Dyspnoea assessment at maximal intensity, quality of life measurement by SF36, drugs and events are reported. Maximal exercise tests with gas exchange measurements are performed after training program and at 6 months follow-up to compare the different cardio respiratory parameters in the two groups before and after exercise training and to evaluate the more effective endurance training program.
Detailed description
- Outline of the training program: Duration of the rehabilitation course is 7 or 10 weeks, 2 or 3 training sessions a week, 21 sessions altogether. Each training session consist in cycling on an ergometer. In the interval training group, the training session alternates one minute at 100% workload at the ventilatory threshold and one minute active pause at 50% workload at the ventilatory threshold; total exercise time is 20 minutes. In continuous training, the training session lasts 20 minutes at 80% workload at the ventilatory threshold.
- Exercise testing: Exercise capacity is measured before and at the end of the exercise training program and at 6 month follow-up. A first exercise test with respiratory gas exchange is performed 2 weeks after hospitalization: this is the baseline exercise test. The protocol consists of 3-min warm up at a workload of 30 watts. At each stage, the workload is increased by 10 or 15 watts per min. Patients are instructed to maintain a speed of 55 to 65 rotations per min. Four exercise tests with gas analysis are programmed during cardiac rehabilitation: three maximal tests (before exercise training program to precise exercise intensity during the sessions, after training program to evaluate the primary end point and at 6 months) and one sub maximal exercise test during the tenth session to adjust the intensity of training exercises (this test is stopped when the ventilatory threshold is obtained).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Continuous versus interval trainingContinuous training |
| 2 | Other | Other: Continuous versus interval trainingInterval training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years
- Patient hospitalized at Limoges University Hospital, cardiology department, for acute coronary syndrome:
- Patients stabilized with medication without rest myocardial ischemia
- Left ventricular ejection fraction >= 35% measured on echocardiography
- Patient who have signed and dated informed consent
Key exclusion criteria (21 listed)
- Contraindication for exercise testing:
- Age < 18 years
- Patient revascularized by coronary artery bypass grafting after acute coronary syndrome
- Chronic supraventricular arrhythmias
- Impossible physical 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 |
|---|---|---|
| Continuous versus interval trainingInfluence of different exercise training programs | Other | 1, 2 |
Primary outcome
The primary endpoint is to compare the effect on ventilatory threshold before and after cardiac rehabilitation in the continuous training group versus interval training group
Time frame: 6 month
1 secondary outcome
The secondary endpoint is to compare the effect on ventilatory threshold before and at 6 month after cardiac rehabilitation in the two groups
Time frame: 6 month
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 8 Sep 2011.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Prisca DEMAISON, MD principal investigator
University Hospital, Limoges
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous versus interval training in people with Acute Coronary Syndrome, run by University Hospital, Limoges at 2 sites in France.
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 9 inclusion and 21 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 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The primary endpoint is to compare the effect on ventilatory threshold before and after cardiac rehabilitation in the continuous training group versus interval training group (time frame: 6 month). 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 8 Sep 2011.