Key result
This is a clinical trial protocol designed to evaluate the safety and efficacy of early in-hospital exercise-based cardiac rehabilitation in patients with acute myocardial infarction; no results are available yet.
Why the study?
Despite the established role of cardiac rehabilitation in outpatient care, few studies have analyzed its use during hospitalization following acute myocardial infarction.
Does early cardiac rehabilitation improve cardiac remodeling, functional capacity, and autonomic balance in patients with acute myocardial infarction?
RCT (n=24)
Single-blind (outcome evaluators blinded)
1:1 allocation ratio using randomly generated numbers concealed in opaque envelopes
No
Does early cardiac rehabilitation improve cardiac remodeling, functional capacity, and autonomic balance in patients with acute myocardial infarction?
This protocol describes a randomized trial to assess the safety and efficacy of early, in-hospital cardiac rehabilitation on cardiac remodeling and functional capacity after acute myocardial infarction.
Does not yet support early in-hospital CR post-AMI; leaves open its safety and efficacy until RCT completion.
The acute myocardial infarction (AMI) present high mortality rate that may be reduced with cardiac rehabilitation. Despite its good establishment in outpatient care, few studies analyzed cardiac rehabilitation during hospitalization. Thus, this study aims to clarify the safety and efficacy of early cardiac rehabilitation after AMI. This will be a clinical, controlled, randomized trial with blind outcome evaluation and a superiority hypothesis. Twenty-four patients with AMI will be divided into two groups (1:1 allocation ratio). The intervention group will receive an individualized exercise-based cardiac rehabilitation protocol during hospitalization and a semi-supervised protocol after hospital discharge; the control group will receive conventional care. The primary outcomes will be the cardiac remodeling assessed by cardiac magnetic resonance imaging, functional capacity assessed by maximal oxygen consumption, and cardiac autonomic balance examined via heart rate variability. Secondary outcomes will include safety and the total exercise dose provided during the protocol. Statistical analysis will consider the intent-to-treat analysis. Trial registration. Trial registration number: Brazilian Registry of Clinical Trials (ReBEC) (RBR- 9nyx8hb).
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Schon et al. (2024) conducted an RCT in Acute myocardial infarction (n=24). Early exercise-based cardiac rehabilitation vs. Conventional care was evaluated on Cardiac remodeling (cMRI), functional capacity (VO2max), and cardiac autonomic balance (HRV). This is a clinical trial protocol designed to evaluate the safety and efficacy of early in-hospital exercise-based cardiac rehabilitation in patients with acute myocardial infarction; no results are available yet.
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