title: Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial.
abstract: BACKGROUND
  Heart failure with preserved left ventricular ejection fraction (HFpEF) currently affects more than seven million Europeans and is the only cardiovascular disease increasing in prevalence and incidence. No pharmacological agent has yet been shown to improve symptoms or prognosis. The most promising way to improve pathophysiology and deprived exercise-tolerance in HFpEF patients seems to be exercise training, but the optimal approach and dose of exercise is still unknown.
  
  
  OBJECTIVE
  The major objective of the optimising exercise training in prevention and treatment of diastolic heart failure study (OptimEx-CLIN) is to define the optimal dose of exercise training in patients with HFpEF. In order to optimise adherence, supervision and economic aspects of exercise training a novel telemedical approach will be introduced and investigated.
  
  
  METHODS
  In a prospective randomised multi-centre study, 180 patients with stable symptomatic HFpEF will be randomised (1:1:1) to moderate intensity continuous training, high intensity interval training, or a control group. The training intervention includes three months supervised followed by nine months of telemedically monitored home-based training. The primary endpoint is change in exercise capacity, defined as change in peak oxygen uptake (VO2peak) after three months, assessed by cardiopulmonary exercise testing. Secondary endpoints include diastolic filling pressure (E/e') and further echocardiographic and cardiopulmonary exercise testing (CPX) parameters, biomarkers, quality of life and endothelial function. Training sessions and physical activity will be monitored and documented throughout the study with accelerometers and heart rate monitors developed on a telemedical platform for the OptimEx-CLIN study. Inclusion of patients started in July 2014, first results are expected in 2017.
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Germany suchy@sport.med.tum.de.
authors.forename: Christiane
authors.initials: C
authors.lastname: Suchy
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Germany.
authors.forename: Lilian
authors.initials: L
authors.lastname: Massen
authors.affiliation: KG Jebsen Center of Exercise in Medicine at Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Norway.
authors.forename: Oivind
authors.initials: O
authors.lastname: Rognmo
authors.affiliation: Department of Cardiology, Antwerp University Hospital, Belgium.
authors.forename: Emeline M
authors.initials: EM
authors.lastname: Van Craenenbroeck
authors.affiliation: Department of Cardiology, Antwerp University Hospital, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Beckers
authors.affiliation: Department of Cardiology, Medical University of Graz, Austria.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Kraigher-Krainer
authors.affiliation: Department of Cardiology, University Leipzig-Heart Center Leipzig, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.affiliation: Department of Cardiology, University Leipzig-Heart Center Leipzig, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Adams
authors.affiliation: KG Jebsen Center of Exercise in Medicine at Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Norway.
authors.forename: Ulrik
authors.initials: U
authors.lastname: Wisløff
authors.affiliation: Department of Cardiology, Medical University of Graz, Austria.
authors.forename: Burkert
authors.initials: B
authors.lastname: Pieske
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Germany DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany Else Kröner-Fresenius-Zentrum, Technische Universität München, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Halle
mesh_terms: D056044:Actigraphy; D004562:Electrocardiography; D005060:Europe; D005080:Exercise Test; D005081:Exercise Therapy; D017079:Exercise Tolerance; D054144:Heart Failure, Diastolic / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control* / Q000628:therapy*; D006339:Heart Rate; D006801:Humans; D011237:Predictive Value of Tests; D011314:Preventive Health Services / Q000379:methods*; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D012815:Signal Processing, Computer-Assisted; D013318:Stroke Volume; D017216:Telemedicine / Q000295:instrumentation; D013686:Telemetry / Q000295:instrumentation; D013997:Time Factors; D014159:Transducers; D016896:Treatment Outcome; D016277:Ventricular Function, Left
keywords: Heart failure; diastolic heart failure; exercise capacity; exercise training; heart failure with preserved ejection fraction; interval training; telemonitoring; training intensity