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NCT07736066

Overview

NCT ID: NCT07736066
Lead Sponsor: HUINNO Co., LtdINDUSTRY
Official Title: Effect of Phase I Cardiac Rehabilitation Based on Remote ECG Monitoring in Patients Undergoing Heart Surgery
Brief Summary: 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.
Conditions: Heart Disease
Cardiac Surgery
Cardiac Rehabilitation

Status and Timeline

Status: Completed
Last Update Posted: Jul 30, 2026Actual
Start Date: Aug 1, 2021Actual
Primary Completion Date: Aug 31, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 22Actual
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Korea University Anam Hospital

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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