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

NCT00754533 | Completed

• 1 other identifier: I08005
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome

Keywords

cardiac rehabilitation; coronary heart disease; interval training; continuous training; ventilatory threshold

Outcome Measures

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

  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

  6 month

Study Arms (2)

1

OTHER

Continuous training

Other: Continuous versus interval training

2

OTHER

Interval training

Other: Continuous versus interval training

Interventions

Continuous versus interval training OTHER

Influence of different exercise training programs

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

Cardiology

Limoges, 87, France

Location

Explorations Fonctionnelles Physiologiques

Limoges, 87, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Prisca DEMAISON, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 8, 2011

Record last verified: 2008-10

Locations

FR (2)