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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous versus interval training
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring cardiac rehabilitation, coronary heart disease, interval training, continuous training, ventilatory threshold

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology
  • Explorations Fonctionnelles Physiologiques

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Continuous training

Interval training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The secondary endpoint is to compare the effect on ventilatory threshold before and at 6 month after cardiac rehabilitation in the two groups

Full Information

First Posted
September 17, 2008
Last Updated
September 7, 2011
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00754533
Brief Title
Continuous Versus Interval Training in Patients With Coronary Artery Disease: FRAXIO Study
Acronym
FRAXIO
Official Title
Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
cardiac rehabilitation, coronary heart disease, interval training, continuous training, ventilatory threshold

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Continuous training
Arm Title
2
Arm Type
Other
Arm Description
Interval training
Intervention Type
Other
Intervention Name(s)
Continuous versus interval training
Intervention Description
Influence of different exercise training programs
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prisca DEMAISON, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology
City
Limoges
ZIP/Postal Code
87
Country
France
Facility Name
Explorations Fonctionnelles Physiologiques
City
Limoges
ZIP/Postal Code
87
Country
France

12. IPD Sharing Statement

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

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