A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training. (SAINTEX-CAD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Edegem, Belgium, 2650
- Recruiting
- Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
-
Contact:
- Viviane M Conraads, MD,PhD
- Phone Number: 0032 38214672
- Email: Viviane.Conraad@uza.be
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Leuven, Belgium, 3000
- Not yet recruiting
- Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49
-
Contact:
- Luc VanHees, MSc, PhD
- Phone Number: 0032 16-329158
- Email: Luc.Vanhees@faber.kuleuven.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IWT-090870
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