Myocardial Infarction (MI)NCT06924034
Early-phase Exercise-based Cardiac Rehabilitation After MI
A study testing Phase I and Phase II Cardiac Rehabilitation Program in people with Myocardial Infarction (MI), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Myocardial Infarction (MI)
- What is being tested?
- Phase I and Phase II Cardiac Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2023to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Myocardial Infarction (MI)
- Being tested
- Phase I and Phase II Cardiac Rehabilitation Program
- Keywords
- Myocardial Infraction, MI, early phase, cardiac rehabilitation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I and Phase II Cardiac Rehabilitation ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Program | Experimental | Patients who perform Phase I and Phase II Cardiac Rehabilitation Program Receives: Other: Phase I and Phase II Cardiac Rehabilitation Program |
| Standard of care | No intervention | The patients who received a usual care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Functional exercise capacity assessment with 6-minute walk test distance as meters
Measured: 8 weeks
Functional exercise capacity
Functional exercise capacity assessment with 30 s sit-stand test repetitions
Measured: 8 weeks
Secondary outcomes (5)
SF-12 Health releated Quality of Life questionnaire
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
Measured: 8 weeks
MacNew Heart Disease Health releated Quality of Life questionnaire
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.
Measured: 8 weeks
Fatigue
Fatigue was assessed with Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (range: 0-52). Lower values on this scale indicate worse symptoms.
Measured: 8 weeks
sleep quality
Sleep quality was assessed with the Pittsburgh Sleep Quality Index (range: 0-21). Higher values on this scale indicate worse symptoms.
Measured: 8 weeks
Grip strength
Hand grip strength with a hand dynamometer (Jamar® ,dynamometer / Promedics Ltd., Blackburn, Lancashire, UK)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start3 Jul 2023
- Primary completion31 May 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Ocaker Aktan, Dokuz Eylul University
- Investigators
- Sevgi Ozalevli, Prof., Study director, Dokuz Eylul UniversityÖzge Ocaker Aktan, PhD (c), Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924034
- Sponsor's protocol ID
- 2024/06-07
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.
PubMed 15668354Sjolin I, Back M, Nilsson L, Schiopu A, Leosdottir M. Association between attending exercise-based cardiac rehabilitation and cardiovascular risk factors at one-year post myocardial infarction. PLoS One. 2020 May 11;15(5):e0232772. doi: 10.1371/journal.pone.0232772. eCollection 2020.
PubMed 32392231Taylor RS, Dalal HM, McDonagh STJ. The role of cardiac rehabilitation in improving cardiovascular outcomes. Nat Rev Cardiol. 2022 Mar;19(3):180-194. doi: 10.1038/s41569-021-00611-7. Epub 2021 Sep 16.
PubMed 34531576Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
PubMed 23747642Suaya JA, Shepard DS, Normand SL, Ades PA, Prottas J, Stason WB. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007 Oct 9;116(15):1653-62. doi: 10.1161/CIRCULATIONAHA.107.701466. Epub 2007 Sep 24.
PubMed 17893274Dalal HM, Zawada A, Jolly K, Moxham T, Taylor RS. Home based versus centre based cardiac rehabilitation: Cochrane systematic review and meta-analysis. BMJ. 2010 Jan 19;340:b5631. doi: 10.1136/bmj.b5631.
PubMed 20085991Peixoto TC, Begot I, Bolzan DW, Machado L, Reis MS, Papa V, Carvalho AC, Arena R, Gomes WJ, Guizilini S. Early exercise-based rehabilitation improves health-related quality of life and functional capacity after acute myocardial infarction: a randomized controlled trial. Can J Cardiol. 2015 Mar;31(3):308-13. doi: 10.1016/j.cjca.2014.11.014. Epub 2014 Dec 11.
PubMed 25633911
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-phase Exercise-based Comprehensive Cardiac Rehabilitation Program After Myocardial Infarction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06924034
- Acronym / sponsor ID
- 2024/06-07
- Conditions
- Myocardial Infarction (MI)
- Keywords
- Myocardial Infraction, MI, early phase, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation Program | Experimental | Other: Phase I and Phase II Cardiac Rehabilitation ProgramPatients who perform Phase I and Phase II Cardiac Rehabilitation Program |
| Standard of care | No intervention | –The patients who received a usual care program |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- having coronary artery bypass graft surgery
- Being diagnosed with chronic renal failure
- Presence of unstable angina
- Atrial fibrillation
- Severe and symptomatic aortic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 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. | Other | Cardiac Rehabilitation Program |
Primary outcome
Functional exercise capacity
Time frame: 8 weeks
Functional exercise capacity assessment with 6-minute walk test distance as meters
Functional exercise capacity
Time frame: 8 weeks
Functional exercise capacity assessment with 30 s sit-stand test repetitions
5 secondary outcomes
SF-12 Health releated Quality of Life questionnaire
Time frame: 8 weeks
MacNew Heart Disease Health releated Quality of Life questionnaire
Time frame: 8 weeks
Fatigue
Time frame: 8 weeks
sleep quality
Time frame: 8 weeks
Grip strength
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 15668354Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.
- Background: PubMed 32392231Sjolin I, Back M, Nilsson L, Schiopu A, Leosdottir M. Association between attending exercise-based cardiac rehabilitation and cardiovascular risk factors at one-year post myocardial infarction. PLoS One. 2020 May 11;15(5):e0232772. doi: 10.1371/journal.pone.0232772. eCollection 2020.
- Background: PubMed 34531576Taylor RS, Dalal HM, McDonagh STJ. The role of cardiac rehabilitation in improving cardiovascular outcomes. Nat Rev Cardiol. 2022 Mar;19(3):180-194. doi: 10.1038/s41569-021-00611-7. Epub 2021 Sep 16.
- Background: PubMed 23747642Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
- Background: PubMed 17893274Suaya JA, Shepard DS, Normand SL, Ades PA, Prottas J, Stason WB. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007 Oct 9;116(15):1653-62. doi: 10.1161/CIRCULATIONAHA.107.701466. Epub 2007 Sep 24.
- Background: PubMed 20085991Dalal HM, Zawada A, Jolly K, Moxham T, Taylor RS. Home based versus centre based cardiac rehabilitation: Cochrane systematic review and meta-analysis. BMJ. 2010 Jan 19;340:b5631. doi: 10.1136/bmj.b5631.
- Background: PubMed 25633911Peixoto TC, Begot I, Bolzan DW, Machado L, Reis MS, Papa V, Carvalho AC, Arena R, Gomes WJ, Guizilini S. Early exercise-based rehabilitation improves health-related quality of life and functional capacity after acute myocardial infarction: a randomized controlled trial. Can J Cardiol. 2015 Mar;31(3):308-13. doi: 10.1016/j.cjca.2014.11.014. Epub 2014 Dec 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgi Ozalevli, Prof. study director
Dokuz Eylul University
Özge Ocaker Aktan, PhD (c) principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I and Phase II Cardiac Rehabilitation Program in people with Myocardial Infarction (MI), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924034, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.