Cardiac Rehabilitation, Cardiac Surgery, Heart Disease
Conditions
Keywords
Cardiac Rehabilitation (CR), Remote ECG Monitoring Electrocardiography (ECG), MEMO Patch Heart Surgery, Telemonitoring Wearable ECG
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.
Detailed description
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.
Interventions
BEHAVIORALPhase 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.
DEVICEMEMO 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.
Sponsors
HUINNO Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking was applied to participants or investigators.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Capacity Assessed by the 6-Minute Walk Test (6MWT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Capacity Assessed by the Symptom-Limited Submaximal Exercise Test | 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. |
| Change in Hand Grip Strength (HGS) | 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. |
| Change in Squat Endurance Assessed by the Squat Endurance Test | 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. |
| 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) | 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. |
| 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) | 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. |
| Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36) | 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. |
Countries
South Korea
Outcome results
None listed