Early-phase Exercise-based Cardiac Rehabilitation After MI

April 5, 2025 updated by: Ozge Ocaker Aktan, Dokuz Eylul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balçova
      • İzmir, Balçova, Turkey, 35330
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Rehabilitation Program
Patients who perform Phase I and Phase II Cardiac Rehabilitation Program
Other: Phase 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.
No Intervention: Standard of care
The patients who received a usual care program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional exercise capacity
Time Frame: 8 weeks
Functional exercise capacity assessment with 6-minute walk test distance as meters
8 weeks
Functional exercise capacity
Time Frame: 8 weeks
Functional exercise capacity assessment with 30 s sit-stand test repetitions
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-12 Health releated Quality of Life questionnaire
Time Frame: 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
8 weeks
MacNew Heart Disease Health releated Quality of Life questionnaire
Time Frame: 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.
8 weeks
Fatigue
Time Frame: 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.
8 weeks
sleep quality
Time Frame: 8 weeks
Sleep quality was assessed with the Pittsburgh Sleep Quality Index (range: 0-21). Higher values on this scale indicate worse symptoms.
8 weeks
Grip strength
Time Frame: 8 weeks
Hand grip strength with a hand dynamometer (Jamar® ,dynamometer / Promedics Ltd., Blackburn, Lancashire, UK)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Study Director: Sevgi Ozalevli, Prof., Dokuz Eylul University
  • Principal Investigator: Özge Ocaker Aktan, PhD (c), Dokuz Eylul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

April 5, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/06-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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