Heart DiseaseNCT07736066
Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery
A study testing MEMO Patch and Phase I Cardiac Rehabilitation Program in people with Heart Disease and Cardiac Surgery, run by HUINNO Co., Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Disease, Cardiac Surgery, Cardiac Rehabilitation
- What is being tested?
- MEMO Patch and Phase I Cardiac Rehabilitation Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 31 Aug 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Disease, Cardiac Surgery, Cardiac Rehabilitation
- Being tested
- MEMO Patch, Phase I Cardiac Rehabilitation Program
- Keywords
- Cardiac Rehabilitation (CR), Remote ECG Monitoring Electrocardiography (ECG), MEMO Patch Heart Surgery, Telemonitoring Wearable ECG
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO PatchDevice
Also called Adhesive ECG 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.
Phase I Cardiac Rehabilitation ProgramBehavioural
Also called Cardiac Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MEMO Patch; Behavioral: Phase I Cardiac Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and end of intervention (approximately 2 weeks after hospital discharge; outpatient visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUINNO Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736066
- Sponsor's protocol ID
- S1MP1-RM
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No