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Early-phase Exercise-based Cardiac Rehabilitation After MI

D

Dokuz Eylül University (DEU)

Status

Completed

Conditions

Myocardial Infarction (MI)

Treatments

Other: Phase I and Phase II Cardiac Rehabilitation Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06924034
2024/06-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

Cardiac Rehabilitation Program
Experimental group
Description:
Patients who perform Phase I and Phase II Cardiac Rehabilitation Program
Treatment:
Other: Phase I and Phase II Cardiac Rehabilitation Program
Standard of care
No Intervention group
Description:
The patients who received a usual care program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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