Early-phase Exercise-based Cardiac Rehabilitation After MI

NCT06924034 | Completed

• 1 other identifier: 2024/06-07
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction (MI)

Keywords

Myocardial Infraction; MI; early phase; cardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

• Functional exercise capacity

  Functional exercise capacity assessment with 6-minute walk test distance as meters

  8 weeks

• Functional exercise capacity

  Functional exercise capacity assessment with 30 s sit-stand test repetitions

  8 weeks

Secondary Outcomes (5)

• SF-12 Health releated Quality of Life questionnaire

  8 weeks

• MacNew Heart Disease Health releated Quality of Life questionnaire

  8 weeks

• Fatigue

  8 weeks

• sleep quality

  8 weeks

• Grip strength

  8 weeks

Study Arms (2)

Cardiac Rehabilitation Program

EXPERIMENTAL

Patients who perform Phase I and Phase II Cardiac Rehabilitation Program

Other: Phase I and Phase II Cardiac Rehabilitation Program

Standard of care

NO INTERVENTION

The patients who received a usual care program

Interventions

Phase I and Phase II Cardiac Rehabilitation Program OTHER

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.

Cardiac Rehabilitation Program

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 15668354 BACKGROUND

• 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.

  PMID: 32392231 BACKGROUND

• 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.

  PMID: 34531576 BACKGROUND

• 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.

  PMID: 23747642 BACKGROUND

• 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.

  PMID: 17893274 BACKGROUND

• 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.

  PMID: 20085991 BACKGROUND

• 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.

  PMID: 25633911 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Clinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sevgi Ozalevli, Prof.

  Dokuz Eylul University

  STUDY DIRECTOR

• Özge Ocaker Aktan, PhD (c)

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 11, 2025
• Study Start: July 3, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 25, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)