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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00754533
First received: September 17, 2008
Last updated: September 7, 2011
Last verified: October 2008
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Other: Continuous versus interval training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Continuous training
Other: Continuous versus interval training
Influence of different exercise training programs
2
Interval training
Other: Continuous versus interval training
Influence of different exercise training programs

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).
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754533

Locations
France
Cardiology
Limoges, France, 87
Explorations Fonctionnelles Physiologiques
Limoges, France, 87
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Prisca DEMAISON, MD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: SENGELEN Marie / Directrice des Affaires Médicales et de la Recherche Clinique, University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00754533     History of Changes
Other Study ID Numbers: I08005
Study First Received: September 17, 2008
Last Updated: September 7, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
cardiac rehabilitation
coronary heart disease
interval training
continuous training
ventilatory threshold

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014