title: Rationale and design of a randomized trial on the effectiveness of aerobic interval training in patients with coronary artery disease: the SAINTEX-CAD study.
abstract: BACKGROUND
  Exercise-based cardiac rehabilitation is considered an important adjunct treatment and secondary prevention measure in patients with coronary artery disease (CAD). However, the issues of training modality and exercise intensity for CAD patients remain controversial.
  
  
  OBJECTIVE
  Main aim of the present study is to test the hypothesis that aerobic interval training (AIT) yields a larger gain in peak aerobic capacity (peakVO2) compared to a similar training programme of moderate continuous training (MCT) in CAD patients.
  
  
  METHODS
  In this multicentre study stable CAD patients with left ventricular ejection fraction>40% will be randomized after recent myocardial infarction or revascularization (PCI or CABG) to a supervised 12-week programme of three weekly sessions of either AIT (85-90% of peak oxygen uptake [peakVO2], 90-95% of peak heart rate) or MCT (60-70% of peakVO2, 65-75% of peak heart rate). The primary endpoint of the study is the change of peakVO2 after 12 weeks training. Secondary endpoints include safety, changes in peripheral endothelial vascular function, the evolution of traditional cardiovascular risk factors, quality of life and the number and function of circulating endothelial progenitor cells as well as endothelial microparticles. Possible differences in terms of long-term adherence to prescribed exercise regimens will be assessed by regular physical activity questionnaires, accelerometry and reassessment of peakVO2 12 months after randomization. A total number of 200 patients will be randomized in a 1:1 manner (significance level of 0.05 and statistical power of 0.90). Enrolment started December 2010; last enrolment is expected for February 2013.
authors.affiliation: Department of Cardiology, Antwerp University Hospital, Edegem, Belgium; University of Antwerp, Antwerp, Belgium. Electronic address: Viviane.Conraads@ua.ac.be.
authors.forename: Viviane M
authors.initials: VM
authors.lastname: Conraads
authors.forename: Emeline M
authors.initials: EM
authors.lastname: Van Craenenbroeck
authors.forename: Nele
authors.initials: N
authors.lastname: Pattyn
authors.forename: Véronique A
authors.initials: VA
authors.lastname: Cornelissen
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Beckers
authors.forename: Ellen
authors.initials: E
authors.lastname: Coeckelberghs
authors.forename: Catherine
authors.initials: C
authors.lastname: De Maeyer
authors.forename: Johan
authors.initials: J
authors.lastname: Denollet
authors.forename: Geert
authors.initials: G
authors.lastname: Frederix
authors.forename: Kaatje
authors.initials: K
authors.lastname: Goetschalckx
authors.forename: Vicky Y
authors.initials: VY
authors.lastname: Hoymans
authors.forename: Nadine
authors.initials: N
authors.lastname: Possemiers
authors.forename: Dirk
authors.initials: D
authors.lastname: Schepers
authors.forename: Bharati
authors.initials: B
authors.lastname: Shivalkar
authors.forename: Luc
authors.initials: L
authors.lastname: Vanhees
mesh_terms: D003324:Coronary Artery Disease / Q000175:diagnosis / Q000503:physiopathology* / Q000628:therapy*; D015444:Exercise / Q000502:physiology*; D017079:Exercise Tolerance / Q000502:physiology*; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D011446:Prospective Studies; D055502:Secondary Prevention / Q000379:methods*; D013318:Stroke Volume / Q000502:physiology*; D016896:Treatment Outcome
keywords: Cardiac rehabilitation; Coronary artery disease; Exercise intensity; Exercise training; Secondary prevention