Key result
Early cardiopulmonary rehabilitation combined with 4 mg daily melatonin supplementation improved functional capacity and sleep quality in male patients hospitalized after AMI and PCI (P<.001).
Why the study?
To evaluate the safety and effectiveness of early cardiopulmonary rehabilitation combined with melatonin supplementation on functional capacity and sleep quality during hospitalization in patients with AMI treated with primary PCI.
Does early cardiopulmonary rehabilitation combined with melatonin supplementation improve functional capacity and sleep quality in male patients hospitalized for acute myocardial infarction after primary PCI?
RCT (n=48)
Single-blinded
Randomized
No
Does early cardiopulmonary rehabilitation combined with melatonin supplementation improve functional capacity and sleep quality in male patients hospitalized for acute myocardial infarction after primary PCI?
p-value: p=<.001
Early cardiopulmonary rehabilitation combined with melatonin supplementation during hospitalization after primary PCI for AMI is safe and improves functional capacity and sleep quality.
Supports adding 4 mg melatonin to ECR post-AMI; extends RCT evidence for combined recovery benefits.
Objective: To investigate the safety and effectiveness of early cardiopulmonary rehabilitation (ECR) combined with melatonin supplementation on functional capacity and sleep quality during hospitalization in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI). Design: Single-blinded randomized controlled trial. Setting: Cardiology inpatient unit where patients were hospitalized after PCI. Participants: Forty-eight male patients (N=48) with AMI followed by PCI (mean age of 57.1±8.7y) were included and randomized into 3 groups: MELEX (ECR combined with 4 mg of exogenous melatonin), EX (ECR with placebo), and CON (control group with placebo). Interventions: Patients in the MELEX and EX groups participated in ECR, consisting of walking, passive and active range of motion, moderate-intensity strengthening exercises, and breathing exercises. The MELEX group received a daily 4 mg dose of melatonin, while the EX and CON groups received a placebo. Participants in CON group received usual care without engaging in ECR. Main Outcomes Measures: Functional capacity was evaluated by the 6-minute walking test (6mwt). Sleep quality was assessed by the Spiegel questionnaire. Rating of perceived exertion was evaluated using the Borg Scale. Assessments were conducted on the first day after PCI and at hospital discharge. Results: <.001). No adverse cardiac events related to ECR or melatonin supplementation were recorded during hospitalization. Conclusions: ECR combined with a daily 4 mg of melatonin supplementation was safe and effective in improving functional capacity and sleep quality in patients with AMI during hospitalization after PCI.
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Hbaieb et al. (2025) conducted an RCT in Acute myocardial infarction (n=48). Early cardiopulmonary rehabilitation combined with melatonin vs. Early cardiopulmonary rehabilitation with placebo, or usual care with placebo was evaluated on Functional capacity (6-minute walking test) and sleep quality (Spiegel questionnaire) (p=<.001). Early cardiopulmonary rehabilitation combined with 4 mg daily melatonin supplementation improved functional capacity and sleep quality in male patients hospitalized after AMI and PCI (P<.001).
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