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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06924034
Enrollment
32
Registered
2025-04-11
Start date
2023-07-03
Completion date
2024-06-25
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction (MI)

Keywords

Myocardial Infraction, MI, early phase, cardiac rehabilitation

Brief 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.

Interventions

OTHERPhase I and Phase II Cardiac Rehabilitation Program

The 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.

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Clinically and medically stable patients with first MI * Prescribed cardiac rehabilitation by a cardiologist * Being between 30-65 years old * having ejection fraction (EF) of more than 20% (i.e. EF≥ 20%) * being volunteer to participate

Exclusion criteria

* having coronary artery bypass graft surgery * Being diagnosed with chronic renal failure * Presence of unstable angina * Atrial fibrillation * Severe and symptomatic aortic stenosis * Presence of decompensated heart failure * Exercise-induced myocardial ischemia, * Pericardial disease, * Moderate-to-severe valve disease * COPD or asthma * BMI \> 40 kg/m2 * Orthopedic and neurological problems that prevent exercise

Design outcomes

Primary

MeasureTime frameDescription
Functional exercise capacity8 weeksFunctional exercise capacity assessment with 6-minute walk test distance as meters

Secondary

MeasureTime frameDescription
SF-12 Health releated Quality of Life questionnaire8 weeksHealth-related Quality of Life was assessed with the SF-12 Health-related Quality of Life questionnaire (range: 0-100). Lower values on this questionnaire indicate worse symptoms
MacNew Heart Disease Health releated Quality of Life questionnaire8 weeksDisease-specific Health-related Quality of Life was assessed with the MacNew Heart Disease Health-related Quality of Life questionnaire (range: 1-7). Lower values on this questionnaire indicate worse symptoms.
Fatigue8 weeksFatigue was assessed with Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (range: 0-52). Lower values on this scale indicate worse symptoms.
sleep quality8 weeksSleep quality was assessed with the Pittsburgh Sleep Quality Index (range: 0-21). Higher values on this scale indicate worse symptoms.
Grip strength8 weeksHand grip strength with a hand dynamometer (Jamar® ,dynamometer / Promedics Ltd., Blackburn, Lancashire, UK)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026