Early-phase Exercise-based Cardiac Rehabilitation After MI

Not Applicable

Completed

• Conditions: Myocardial Infarction (MI)

• Registration Number: NCT06924034
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2023-07-03
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-25
• Study First Submitted: 2025-03-30
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-05
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional exercise capacity	8 weeks	Functional exercise capacity assessment with 30 s sit-stand test repetitions

Secondary Outcome Measures

Name	Time	Method
SF-12 Health releated Quality of Life questionnaire	8 weeks	Health-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 questionnaire	8 weeks	Disease-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.
Fatigue	8 weeks	Fatigue was assessed with Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (range: 0-52). Lower values on this scale indicate worse symptoms.
sleep quality	8 weeks	Sleep quality was assessed with the Pittsburgh Sleep Quality Index (range: 0-21). Higher values on this scale indicate worse symptoms.
Grip strength	8 weeks	Hand grip strength with a hand dynamometer (Jamar® ,dynamometer / Promedics Ltd., Blackburn, Lancashire, UK)

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 İzmir, Balçova, Turkey