Effectiveness of Early Cardiorespiratory Rehabilitation Combined With Melatonin Supplementation During the Inpatient Period After Acute Myocardial Infarction: a Pilot Study

Abstract

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

The 6mwt distance was better in the MELEX group than in the other groups exceeding the minimal clinically important differences (P<.001). Sleep quality was improved more in MELEX than EX and CON groups (P<.001). A strong-graded correlation was found between the 6mwt and Spiegel Score (r=0.730; P<.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.