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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Unknown status

CT.gov ID

NCT01226225

Collaborator

KU Leuven (Other), Universitaire Ziekenhuizen Leuven (Other)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease (CAD); Myocardial Infarction (MI) Percutaneous Coronary Intervention (PCI) Coronary Artery Bypass Grafting (CABG)	Behavioral: Aerobic interval training Behavioral: Moderate endurance training	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2013

Anticipated Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic interval training	Behavioral: Aerobic interval training Patients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.
Active Comparator: Moderate endurance training	Behavioral: Moderate endurance training Patients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Arm

Intervention/Treatment

Experimental: Aerobic interval training

Behavioral: Aerobic interval training

Patients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Active Comparator: Moderate endurance training

Behavioral: Moderate endurance training

Patients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.

Outcome Measures

Primary Outcome Measures

Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing [6 weeks]
Comparison of evolution of maximal aerobic capacity from baseline to 6 weeks
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing [12 weeks]
Comparison of evolution of maximal aerobic capacity from baseline to 12 weeks
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing [12 months]
Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen	Edegem		Belgium	2650
2	Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49	Leuven		Belgium	3000