Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery
2026년 7월 28일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
22
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Seoul, 대한민국, 02841
- Korea University Anam Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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.
다른 이름들:
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Exercise Capacity Assessed by the Symptom-Limited Submaximal Exercise Test
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2021년 8월 1일
기본 완료 (실제)
기본 완료
2023년 8월 31일
연구 완료 (실제)
연구 완료
2023년 8월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 28일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 28일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- S1MP1-RM
약물 및 장치 정보, 연구 문서
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아니
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아니
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