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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01226225
Acronym
SAINTEX-CAD
Enrollment
200
Registered
2010-10-22
Start date
2010-11-30
Completion date
2013-09-30
Last updated
2010-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Patients with recent coronary event

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.

Interventions

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.

BEHAVIORALModerate 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.

Sponsors

KU Leuven
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing6 weeksComparison of evolution of maximal aerobic capacity from baseline to 6 weeks

Countries

Belgium

Contacts

Primary ContactViviane M Conraads, MD, PhD
Viviane.Conraads@uza.be38214672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026