Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery
28. července 2026 aktualizováno: HUINNO Co., Ltd
Effect of Phase I Cardiac Rehabilitation Based on Remote ECG Monitoring in Patients Undergoing Heart Surgery
This prospective, single-arm study aims to evaluate the effectiveness of Phase I cardiac rehabilitation based on remote electrocardiographic (ECG) monitoring in patients undergoing heart surgery.
Eligible participants will receive a comprehensive cardiac rehabilitation program consisting of inpatient and home-based rehabilitation while wearing the MEMO Patch for remote ECG monitoring.
Clinical outcomes, including functional exercise capacity, exercise performance, muscle strength, physical function, and health-related quality of life, will be evaluated before rehabilitation, before hospital discharge, and after completion of the rehabilitation program.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
Eligible participants who provide written informed consent will undergo baseline assessments and participate in a Phase I cardiac rehabilitation program using the MEMO Patch for remote ECG monitoring.
The cardiac rehabilitation program consists of approximately one week of inpatient rehabilitation followed by approximately two weeks of home-based rehabilitation. During the study period, participants will wear the MEMO Patch for ECG and physical activity monitoring, receive remote feedback and coaching from study personnel, and record their exercise in an exercise diary.
Clinical assessments will be performed at baseline, before hospital discharge, and at the end of the intervention (approximately two weeks after discharge during an outpatient visit). Baseline and pre-discharge assessments include anthropometric measurements, hand grip strength, the 6-minute walk test (6MWT), the Korean Activity Scale Index (KASI), the EuroQol-5 Dimension (EQ-5D), and the Short Form-36 (SF-36). A symptom-limited submaximal exercise test and squat endurance test will also be performed before hospital discharge. At the end of the intervention, participants will undergo anthropometric measurements, an incremental symptom-limited exercise test, hand grip strength, the 6-minute walk test, squat endurance test, KASI, EQ-5D, SF-36, and a MEMO Patch satisfaction survey to evaluate the effectiveness of the intervention.
Typ studie
Intervenční
Zápis (Aktuální)
22
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Seoul, Jižní Korea, 02841
- Korea University Anam Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Adults aged 19 years or older
- Patients diagnosed with cardiovascular disease (e.g., acute coronary syndrome, heart failure, or valvular heart disease) who have undergone cardiac surgery
- Low- or intermediate-risk patients with a left ventricular ejection fraction (LVEF) of 35% or greater on echocardiography
- Patients with sufficient cognitive ability to understand the cardiac rehabilitation program using a mobile device, application, and the MEMO Patch
- Patients who were independently ambulatory prior to surgery
- Patients capable of undergoing an exercise stress test
- Patients who voluntarily provide written informed consent to participate in the study
Exclusion Criteria:
- High-risk patients (e.g., patients with aortic dissection, survivors of cardiac arrest or sudden cardiac death, or patients with an implantable cardioverter-defibrillator)
- Patients with uncontrolled medical diseases
- Patients who are unable to walk independently
- Patients with contractures of the hip, knee, or ankle joints that interfere with walking
- Patients with musculoskeletal or neurological disorders affecting the lower extremities
- Patients with physical conditions that preclude high-intensity gait training
- Patients receiving other treatments that may affect the safety or efficacy assessments
- Patients who do not provide written informed consent to participate in this clinical study
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation
Participants undergo a Phase I cardiac rehabilitation program based on remote ECG monitoring using the MEMO Patch.
The intervention consists of approximately one week of inpatient cardiac rehabilitation followed by approximately two weeks of home-based cardiac rehabilitation.
Participants wear the MEMO Patch throughout the intervention period for continuous ECG and physical activity monitoring and receive remote feedback and coaching from study personnel.
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The MEMO Patch is a wearable adhesive electrocardiographic (ECG) monitoring device that continuously records ECG signals and physical activity.
The device is used to remotely monitor participants during the study and enables study personnel to review physiological data throughout the rehabilitation period.
Ostatní jména:
Participants receive a Phase I cardiac rehabilitation program consisting of approximately one week of inpatient cardiac rehabilitation followed by approximately two weeks of home-based cardiac rehabilitation.
The program includes individualized exercise therapy, education, and home-based rehabilitation with regular follow-up.
Clinical assessments are performed at baseline, before hospital discharge, and at the end of the intervention to evaluate rehabilitation outcomes.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT)
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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The change in exercise capacity will be evaluated by comparing the distance walked during the 6-Minute Walk Test (6MWT) before and after the intervention.
The 6-Minute Walk Test (6MWT) measures the distance walked in meters (m) over a 6-minute period.
A greater distance walked indicates better exercise capacity.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Exercise Capacity Assessed by the Symptom-Limited Submaximal Exercise Test
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge)
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The change in exercise capacity will be evaluated by comparing maximal work capacity (Wmax), defined as the highest workload sustained for 30 seconds during the symptom-limited submaximal exercise test, before and after the intervention.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge)
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Change in Hand Grip Strength (HGS)
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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The change in muscle strength will be evaluated by comparing hand grip strength measured using a hand dynamometer before and after the intervention.
The highest value obtained from two measurements of each hand will be used for analysis.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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Change in Squat Endurance Assessed by the Squat Endurance Test
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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The change in lower-extremity muscle endurance will be evaluated by comparing the number of squats performed during the Squat Endurance Test before and after the intervention.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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Change in Physical Function Assessed by the Korean Activity Scale Index (KASI)
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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The change in patient-reported physical function will be evaluated by comparing scores on the Korean Activity Scale Index (KASI) before and after the intervention.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension (EQ-5D)
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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The change in health-related quality of life will be evaluated by comparing scores on the EuroQol 5-Dimension (EQ-5D) before and after the intervention.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
Časové okno: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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The change in health-related quality of life will be evaluated by comparing scores on the 36-Item Short Form Health Survey (SF-36) before and after the intervention.
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Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. srpna 2021
Primární dokončení (Aktuální)
31. srpna 2023
Dokončení studie (Aktuální)
31. srpna 2023
Termíny zápisu do studia
První předloženo
22. července 2026
První předloženo, které splnilo kritéria kontroly kvality
28. července 2026
První zveřejněno (Aktuální)
30. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- S1MP1-RM
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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