Clinical trial NCT06924034: Early-phase Exercise-based Cardiac Rehabilitation After MI
Official title: Early-phase Exercise-based Comprehensive Cardiac Rehabilitation Program After Myocardial Infarction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction (MI)
Keywords: Myocardial Infraction
MI
early phase
cardiac rehabilitation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional exercise capacity
timeFrame: 8 weeks
measure: Functional exercise capacity
timeFrame: 8 weeks
Secondary outcomes:
measure: SF-12 Health releated Quality of Life questionnaire
timeFrame: 8 weeks
measure: MacNew Heart Disease Health releated Quality of Life questionnaire
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
measure: sleep quality
timeFrame: 8 weeks
measure: Grip strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
state: Balçova
Study officials:
affiliation: Dokuz Eylul University
name: Sevgi Ozalevli, Prof.
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Özge Ocaker Aktan, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sjolin 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.
citation: Taylor 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.
citation: Yancy 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.
citation: Suaya 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.
citation: Dalal 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.
citation: Peixoto 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.