A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training. (SAINTEX-CAD)
|ClinicalTrials.gov Identifier: NCT01226225|
Recruitment Status : Unknown
Verified August 2010 by University Hospital, Antwerp.
Recruitment status was: Recruiting
First Posted : October 22, 2010
Last Update Posted : November 10, 2010
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
|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.
- Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226225
|Contact: Viviane M Conraads, MD, PhD||38214672 ext 0032||Viviane.Conraads@uza.be|
|Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen||Recruiting|
|Edegem, Belgium, 2650|
|Contact: Viviane M Conraads, MD,PhD 38214672 ext 0032 Viviane.Conraad@uza.be|
|Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49||Not yet recruiting|
|Leuven, Belgium, 3000|
|Contact: Luc VanHees, MSc, PhD 16-329158 ext 0032 Luc.Vanhees@faber.kuleuven.be|