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The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial.

Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF - Trials (2015)

Bottom Line: 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.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.New strategies that can improve left ventricular diastolic function are clinically needed.

View Article: PubMed Central - PubMed

Affiliation: Cardiology Department, Gaia Hospital Centre, Rua Conceicao Fernandes, 4434-502 Vila, Nova Gaia, Portugal. fontes.carvalho@gmail.com.

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/design: 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.

Discussion: 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.

Trial registration: Registered with ClinicalTrials.gov (reference: NCT02224495 ) on 21 August 2014.

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Related in: MedlinePlus

Design of the trial. In this prospective, randomized, open-label, blinded-endpoint trial consecutive patients who have had an acute myocardial infarction one month previously will be randomized (1:1) to an eight-week outpatient exercise training program or standard of care. The primary endpoint will be the change in lateral E’ velocity between baseline and follow-up.
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Fig1: Design of the trial. In this prospective, randomized, open-label, blinded-endpoint trial consecutive patients who have had an acute myocardial infarction one month previously will be randomized (1:1) to an eight-week outpatient exercise training program or standard of care. The primary endpoint will be the change in lateral E’ velocity between baseline and follow-up.

Mentions: In this prospective, randomized, open-label, blinded-endpoint (“The Effect of Exercise Training on Cardiac Structure and Function”) trial, patients who have had an AMI one month previously will be randomized (1:1) to be included in an eight-week duration exercise training program or a control group, receiving standard of care. Immediately before enrolment and at the end of the follow-up period, patients will be submitted to a clinical evaluation, detailed echocardiography, cardiopulmonary exercise testing, and an anthropometric assessment, according to the study design outlined in Figure 1. Because the intervention is a structured exercise training program, it is not possible to perform patient blinding. However, the medical staff performing all the measurements will be blinded to the type of intervention.Figure 1


The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial.

Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF - Trials (2015)

Design of the trial. In this prospective, randomized, open-label, blinded-endpoint trial consecutive patients who have had an acute myocardial infarction one month previously will be randomized (1:1) to an eight-week outpatient exercise training program or standard of care. The primary endpoint will be the change in lateral E’ velocity between baseline and follow-up.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4359575&req=5

Fig1: Design of the trial. In this prospective, randomized, open-label, blinded-endpoint trial consecutive patients who have had an acute myocardial infarction one month previously will be randomized (1:1) to an eight-week outpatient exercise training program or standard of care. The primary endpoint will be the change in lateral E’ velocity between baseline and follow-up.
Mentions: In this prospective, randomized, open-label, blinded-endpoint (“The Effect of Exercise Training on Cardiac Structure and Function”) trial, patients who have had an AMI one month previously will be randomized (1:1) to be included in an eight-week duration exercise training program or a control group, receiving standard of care. Immediately before enrolment and at the end of the follow-up period, patients will be submitted to a clinical evaluation, detailed echocardiography, cardiopulmonary exercise testing, and an anthropometric assessment, according to the study design outlined in Figure 1. Because the intervention is a structured exercise training program, it is not possible to perform patient blinding. However, the medical staff performing all the measurements will be blinded to the type of intervention.Figure 1

Bottom Line: 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.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.New strategies that can improve left ventricular diastolic function are clinically needed.

View Article: PubMed Central - PubMed

Affiliation: Cardiology Department, Gaia Hospital Centre, Rua Conceicao Fernandes, 4434-502 Vila, Nova Gaia, Portugal. fontes.carvalho@gmail.com.

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/design: 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.

Discussion: 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.

Trial registration: Registered with ClinicalTrials.gov (reference: NCT02224495 ) on 21 August 2014.

Show MeSH
Related in: MedlinePlus