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CompletedNCT00754533FRAXIOUpdated Sep 8, 2011

Continuous Versus Interval Training in Patients With Coronary Artery Disease: FRAXIO Study

An interventional study of Continuous versus interval training in Acute Coronary Syndrome, sponsored by University Hospital, Limoges. Completed at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-08.

Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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).
02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • cardiac rehabilitation
  • coronary heart disease
  • interval training
  • continuous training
  • ventilatory threshold
03

In context

Acute Coronary Syndrome

1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.

This study's planned enrollment of 64 is below the median of 200 across 880 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 262 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Other
    1

    Continuous training

    Other: Continuous versus interval training

  • Other
    2

    Interval training

    Other: Continuous versus interval training

Interventions

  • OtherContinuous versus interval training

    Influence of different exercise training programs

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 6 month

07

Study locations

2 sites
  • Cardiology
    Limoges, 87, France
  • Explorations Fonctionnelles Physiologiques
    Limoges, 87, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00754533
First posted
Sep 18, 2008
Start date
Sep 2008
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 8, 2011

Study contacts

Prisca DEMAISON, MD
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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