title: The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Exercise training is effective in improving functional capacity and quality of life in patients with coronary artery disease, but its effects on left ventricular systolic and diastolic function are controversial. Diastolic dysfunction is a major determinant of adverse outcome after myocardial infarction and, contrary to systolic function, no therapy or intervention has proved to significantly improve diastolic function. Data from animal studies and from patients with diastolic heart failure has suggested that exercise training can have a positive effect on diastolic function parameters. This trial aims to evaluate if a structured exercise training program can improve resting left ventricular diastolic and systolic function in patients who have had an acute myocardial infarction.
  
  
  METHODS
  This is a phase II, prospective, randomized, open-label, blinded-endpoint trial that will include at least 96 consecutive patients who have had an acute myocardial infarction one month previously. Patients will be randomized (1:1) to an exercise training program or a control group, receiving standard of care. At enrolment, and at the end of the follow-up period, patients will be submitted to an echocardiography (with detailed assessment of diastolic and systolic function using recent consensus guidelines), cardiopulmonary exercise testing, an anthropometric assessment, blood testing, and clinical evaluation. Patients randomized to the intervention group will be submitted to an eight-week outpatient exercise program, combining endurance and resistance training, for three sessions per week. The primary endpoint will be the change in lateral E' velocity immediately after the eight-week exercise training program. Secondary endpoints will include other echocardiographic parameters of left ventricular diastolic and systolic function, cardiac structure, metabolic and inflammation biomarkers (high-sensitivity C-reactive protein and pro-BNP), functional capacity (peak oxygen consumption and anaerobic threshold) and anthropometric measurements.
  
  
  CONCLUSIONS
  New strategies that can improve left ventricular diastolic function are clinically needed. This will be the first trial to evaluate, in patients who have had an acute myocardial infarction, the effects of a structured program of exercise training on diastolic and systolic function, assessed by novel echocardiographic parameters.
  
  
  BACKGROUND
  Registered with ClinicalTrials.gov (reference: NCT02224495 ) on 21 August 2014.
authors: Cardiology Department, Gaia Hospital Centre, Rua Conceicao Fernandes, 4434-502 Vila, Nova Gaia, Portugal. fontes.carvalho@gmail.com.|Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto, Al. Prof. Hernâni Monteiro, 4200 - 319, Porto, Portugal. fontes.carvalho@gmail.com.
authors: Ricardo
authors: R
authors: Fontes-Carvalho
authors: Cardiology Department, Gaia Hospital Centre, Rua Conceicao Fernandes, 4434-502 Vila, Nova Gaia, Portugal. fpasampaio@gmail.com.
authors: Francisco
authors: F
authors: Sampaio
authors: Cardiology Department, Gaia Hospital Centre, Rua Conceicao Fernandes, 4434-502 Vila, Nova Gaia, Portugal. mteix@chvng.min-saude.pt.
authors: Madalena
authors: M
authors: Teixeira
authors: Cardiology Department, Gaia Hospital Centre, Rua Conceicao Fernandes, 4434-502 Vila, Nova Gaia, Portugal. vasco@chvng.min-saude.pt.
authors: Vasco
authors: V
authors: Gama
authors: Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto, Al. Prof. Hernâni Monteiro, 4200 - 319, Porto, Portugal. amoreira@med.up.pt.|Department of Cardiothoracic Surgery, Centro Hospitalar São João, Al. Prof. Hernâni Monteiro, 4200 - 319, Porto, Portugal. amoreira@med.up.pt.
authors: Adelino F
authors: AF
authors: Leite-Moreira
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000886:Anthropometry; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D004452:Echocardiography; D005080:Exercise Test; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008297:Male; D008875:Middle Aged; D009200:Myocardial Contraction; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010807:Physical Endurance; D011174:Portugal; D011237:Predictive Value of Tests; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D055070:Resistance Training; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D055815:Young Adult
chemical_list: D015415:Biomarkers; D018836:Inflammation Mediators