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

Percutaneous Coronary Intervention (PCI) Clinical Trial

— SAINTEX-CAD  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01226225
• Other study ID #: IWT-090870
• Status: Recruiting
• Phase: Phase 3
• First received: August 19, 2010
• Last updated: November 9, 2010
• Start date: November 2010
• Est. completion date: September 2013

Study information

• Verified date: August 2010
• Source: University Hospital, Antwerp
• Contact: Viviane M Conraads, MD, PhD
• Phone: 38214672
• Email: Viviane.Conraads[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting (CABG)
• Coronary Artery Disease
• Coronary Artery Disease (CAD);
• Coronary Disease
• Myocardial Infarction
• Myocardial Infarction (MI)
• Myocardial Ischemia
• Percutaneous Coronary Intervention (PCI)

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Katholieke Universiteit Leuven, Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing	Comparison of evolution of maximal aerobic capacity from baseline to 6 weeks	6 weeks	No
Primary	Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing	Comparison of evolution of maximal aerobic capacity from baseline to 12 weeks	12 weeks	No
Primary	Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing	Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing	12 months	No