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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00754533 |
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Date of registration:
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17/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Continuous Versus Interval Training in Patients With Coronary Artery Disease: FRAXIO Study
FRAXIO |
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Scientific title:
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Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00754533 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Prisca DEMAISON, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Limoges |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Contraindication for exercise testing:
- acute myocardial infraction < 5 days
- unstable angina
- left main coronary stenosis
- uncontrolled cardiac arrhythmia
- uncontrolled symptomatic heart failure
- 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Coronary Syndrome
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Intervention(s)
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Other: Continuous versus interval training
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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