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

Last updated: November 9, 2010
Sponsor: University Hospital, Antwerp
Overall Status: Trial Status Unknown

Phase

3

Condition

Chest Pain

Heart Disease

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT01226225
IWT-090870
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejectionfraction (LVEF) > 40%

  • the presence of CAD is defined as prior angiographically documented stenotic lesion(s)of > 75%, or documented myocardial infarction (biochemical, ECG, echocardiographicdocumentation).

  • patients are on optimal medical treatment and stable with regard to symptoms andpharmacotherapy for at least 4 weeks

  • in practice, patients will have been hospitalized at least 4 weeks prior toparticipation in the training programme because of PCI, MI or CABG

Exclusion

Exclusion Criteria:

  • significant intercurrent illness last 6 weeks

  • known severe ventricular arrhythmia with functional or prognostic significance

  • significant myocardial ischemia, hemodynamic deterioration or exercise-inducedarrhythmia at baseline testing

  • recent CABG (< 30 days)

  • other heart disease that limits exercise tolerance (valve disease with significanthemodynamic 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 exercisetraining less than 3 months before inclusion

  • acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatorydrugs 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

Total Participants: 200
Study Start date:
November 01, 2010
Estimated Completion Date:
September 30, 2013

Connect with a study center

  • Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49

    Leuven, 3000
    Belgium

    Site Not Available

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