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Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery

2026年7月28日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

22

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 韓国
      • Seoul、韓国、02841
        • Korea University Anam Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：MEMO Patch
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.
他の名前：
  • Adhesive ECG Patch
行動：Phase I Cardiac Rehabilitation Program
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.
他の名前：
  • 心臓リハビリテーション

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT)
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Exercise Capacity Assessed by the Symptom-Limited Submaximal Exercise Test
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge)
Change in Hand Grip Strength (HGS)
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Change in Squat Endurance Assessed by the Squat Endurance Test
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Change in Physical Function Assessed by the Korean Activity Scale Index (KASI)
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension (EQ-5D)
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
時間枠：Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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.
Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

HUINNO Co., Ltd

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年8月1日

一次修了 (実際)

2023年8月31日

研究の完了 (実際)

2023年8月31日

試験登録日

最初に提出

2026年7月22日

QC基準を満たした最初の提出物

2026年7月28日

最初の投稿 (実際)

2026年7月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30日

QC基準を満たした最後の更新が送信されました

2026年7月28日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • S1MP1-RM

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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