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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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.
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.
Korea University Anam Hospital
Seoul, South Korea
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.
Time frame: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Change in Exercise Capacity Assessed by the Symptom-Limited Submaximal Exercise Test
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.
Time frame: Baseline and end of intervention (approximately 2 weeks after hospital discharge)
Change in Hand Grip Strength (HGS)
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.
Time frame: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Change in Squat Endurance Assessed by the Squat Endurance Test
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
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