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

NCT07736066 | Completed

• 1 other identifier: S1MP1-RM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac Rehabilitation (CR); Remote ECG Monitoring Electrocardiography (ECG); MEMO Patch Heart Surgery; Telemonitoring Wearable ECG

Outcome Measures

Primary Outcomes (1)

• Change in Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT)

  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)

Secondary Outcomes (6)

• Change in Exercise Capacity Assessed by the Symptom-Limited Submaximal Exercise Test

  Baseline and end of intervention (approximately 2 weeks after hospital discharge)

• Change in Hand Grip Strength (HGS)

  Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)

• Change in Squat Endurance Assessed by the Squat Endurance Test

  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)

  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)

  Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)

Study Arms (1)

Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation

EXPERIMENTAL

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.

Device: MEMO Patch; Behavioral: Phase I Cardiac Rehabilitation Program

Interventions

MEMO Patch DEVICE

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.

Also known as: Adhesive ECG Patch

Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation

Phase I Cardiac Rehabilitation Program BEHAVIORAL

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.

Also known as: Cardiac Rehabilitation

Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HUINNO Co., Ltd: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied to participants or investigators.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants undergo baseline assessment and participate in 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. Clinical assessments are performed at baseline, before hospital discharge, and at the end of the intervention during an outpatient visit to evaluate the effectiveness of the rehabilitation program.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

KR (1)