Clinical Trials Directory

Trials / Completed

CompletedNCT06924034

Early-phase Exercise-based Cardiac Rehabilitation After MI

Early-phase Exercise-based Comprehensive Cardiac Rehabilitation Program After Myocardial Infarction: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Dokuz Eylul University · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This study aimed to investigate the effects of early-phase exercise-based supervised cardiac rehabilitation on functional exercise capacity, grip strength, fatigue, sleep quality, and health-related quality of life.

Detailed description

Myocardial infarction (MI) is not only a severe form of coronary heart disease but also a leading cause of death and physical disability, particularly in the rapidly growing elderly population. Although percutaneous coronary interventions reduce mortality, ensuring the recovery and reintegration of discharged patients into society remains an unresolved issue. Cardiac rehabilitation (CR) is beneficial for patients with MI in terms of reducing cardiovascular mortality and hospital readmissions, managing cardiovascular risk factors, and improving aerobic capacity. CR is a comprehensive intervention tailored to the individual needs of patients diagnosed with heart disease. It includes personalized exercise training, physical activity promotion, health education, cardiovascular risk management, and psychological support. Initial recommendations for CR were limited to low-risk patients following MI. However, over the past two decades, with the accumulation of evidence supporting the benefits of CR, current clinical guidelines now routinely recommend comprehensive CR for a broader range of cardiac diagnoses, including acute coronary syndrome and heart failure with reduced ejection fraction. Until two decades ago, studies recommended starting CR in the early phase, defined as the second-week post-discharge. However, in the past decade, CR initiation with very low-intensity exercise activity as early as one week after MI onset has been reported as safe and effective. More recently, studies have shown the beneficial effects of terminating bed rest within 12-24 hours and initiating bedside activities. Phase I exercise-based CR has been shown to be effective in improving exercise capacity and preventing recurrent cardiac events. Nonetheless, concerns remain regarding early exercise-based CR due to exercise-induced ischemia after acute MI. While the effects of early rehabilitation initiated post-MI have been investigated in the literature, sufficient evidence has yet to be established.

Conditions

Interventions

TypeNameDescription
OTHERPhase I and Phase II Cardiac Rehabilitation ProgramThe program consisted of two stages: an inpatient phase lasting until discharge, followed by an outpatient-supervised Phase II lasting eight weeks. In the intervention group, the participants in the inpatient phase received active-participatory lower extremity movements and progressive walking training (i.e., progressive walking in the room-corridor-hospital) to prepare them for discharge. The inpatient phase I was conducted with supervision following the American Heart Association recommendations. Participants in the intervention group were then administered phase II of the supervised CR program. Phase II CR was performed 3 non-consecutive days a week for 8 weeks as an aerobic exercise program.

Timeline

Start date
2023-07-03
Primary completion
2024-05-31
Completion
2024-06-25
First posted
2025-04-11
Last updated
2025-04-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06924034. Inclusion in this directory is not an endorsement.