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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. (SAINTEX-CAD)

This study is currently recruiting participants.
Verified August 2010 by University Hospital, Antwerp
Sponsor:
Collaborators:
Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01226225
First received: August 19, 2010
Last updated: November 9, 2010
Last verified: August 2010
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing


Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226225

Contacts
Contact: Viviane M Conraads, MD, PhD 38214672 ext 0032 Viviane.Conraads@uza.be

Locations
Belgium
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    
Sponsors and Collaborators
University Hospital, Antwerp
Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Antwerp University Hospital, Belgium
ClinicalTrials.gov Identifier: NCT01226225     History of Changes
Other Study ID Numbers: IWT-090870
Study First Received: August 19, 2010
Last Updated: November 9, 2010
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
Patients with recent coronary event

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 23, 2013