A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training. (SAINTEX-CAD)

Antwerp University Hospital (UZA)

Status and phase

Unknown

Phase 3

Conditions

Coronary Artery Bypass Grafting (CABG)

Myocardial Infarction (MI)

Percutaneous Coronary Intervention (PCI)

Coronary Artery Disease (CAD);

Treatments

Behavioral: Moderate endurance training

Behavioral: Aerobic interval training

Study type

Interventional

Funder types

Other

Identifiers

NCT01226225

IWT-090870

Details and patient eligibility

About

Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. The ability to be able to perform at a higher maximal level is a strong predictor for outcome (new cardiovascular events and mortality). The main purpose of this study is to evaluate whether aerobic interval training outweighs more classical moderate endurance training in improving exercise capacity. During interval training, patients perform exercise at high intensity, but for only a couple of minutes and then recover at a lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests that this type of training leads to a larger increase in exercise capacity, compared to the more traditional endurance training at moderate intensity.

In addition, mechanisms that might explain how this improvement is achieved, as well as safety and impact on quality of life will be studied.

Enrollment

200 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejection fraction (LVEF) > 40%
the presence of CAD is defined as prior angiographically documented stenotic lesion(s) of > 75%, or documented myocardial infarction (biochemical, ECG, echocardiographic documentation).
patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of PCI, MI or CABG

Exclusion criteria

significant intercurrent illness last 6 weeks
known severe ventricular arrhythmia with functional or prognostic significance
significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
recent CABG (< 30 days)
other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
co-morbidity that may significantly influence one-year prognosis
functional or mental disability that may limit exercise
a habit of regular vigorous exercise or participation in a programme of exercise training less than 3 months before inclusion
acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
glomerular filtration rate (GFR) <25ml/min/1.73m2
hemoglobin < 10g/dl
severe chronic obstructive pulmonary disease
participation in another clinical trial