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임상시험 NCT07385534 (LB-EMS-PMW)은(는) 근감소증, 동맥경화증, Arterial Stiffness, Blood Pressure, 폐경 후 여성에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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서울대학교Effects of Lower Body EMS Training in Postmenopausal Women (LB-EMS-PMW) 39 무작위 배정 운동
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임상시험 NCT07385534 (LB-EMS-PMW)은(는) 근감소증, 동맥경화증, Arterial Stiffness, Blood Pressure, 폐경 후 여성에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 12월 26일에 시작되어 39명의 참여자를 모집하고 있습니다. 서울대학교이(가) 진행하며, 2026년 5월 26일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 4일에 갱신되었습니다.
간단한 개요
This study evaluates the effects of a 6-week lower body Electrical Muscle Stimulation (EMS) training program on body composition, muscle function, and arteriosclerosis markers in postmenopausal women.
Menopause is associated with a rapid decline in estrogen, which increases the risk of sarcopenia (muscle loss) and arterial stiffness (cardiovascular disease). While resistance training is effective for these condition...
더 보기공식 제목
Effects of Lower Body Electrical Muscle Stimulation Training on Body Composition, Muscle Function, and Arteriosclerosis Markers in Postmenopausal Women
질환명
근감소증동맥경화증Arterial Stiffness, Blood Pressure폐경 후 여성기타 연구 식별자
- LB-EMS-PMW
- IRB No. 2601/002-017
NCT 번호
실제 연구 시작일
2025-12-26
최신 업데이트 게시
2026-02-04
예상 연구 완료일
2026-05-26
계획된 등록 인원
39
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Electrical Muscle Stimulation
EMS
Resistance Training
Postmenopausal Women
Body Composition
Vascular Health
Muscle Function
EMS
Resistance Training
Postmenopausal Women
Body Composition
Vascular Health
Muscle Function
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Lower Body EMS + Resistance Training Group Participants perform lower body resistance training while wearing a lower body EMS suit. Each session lasts 50 minutes (10-min warm-up, 30-min main exercise, 10-min cool-down). EMS stimulation is applied exclusively during the 30-minute main exercise phase (85Hz, 350µs). This program is conducted twice a week for 6 weeks. | Lower-body Electromyostimulation (LB-EMS) device Electrical stimulation applied to the lower body muscles (85Hz, 350µs) during the main exercise phase Lower Body Resistance Training A 50-minute session consisting of a 10-minute warm-up, 30 minutes of main lower body resistance training (4 types of machine-based exercises per session), and a 10-minute cool-down |
활성 대조군Resistance Training Only Group Participants perform the identical lower body resistance training program without EMS stimulation. The session structure (10-min warm-up, 30-min main exercise, 10-min cool-down) and total duration (50 minutes) are the same as the experimental group. | Lower Body Resistance Training A 50-minute session consisting of a 10-minute warm-up, 30 minutes of main lower body resistance training (4 types of machine-based exercises per session), and a 10-minute cool-down |
비개입Control Group Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Brachial-ankle Pulse Wave Velocity (baPWV) | An indicator of arterial stiffness. Higher values indicate stiffer arteries. Unit of Measure: cm/s | Baseline and Week 6 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Ankle-Brachial Index (ABI) | The Ankle-Brachial Index (ABI) is the ratio of the systolic blood pressure measured at the ankle to the systolic blood pressure measured at the brachial artery. It is a non-invasive indicator used to assess the presence and severity of peripheral arterial stenosis or occlusion. Lower ABI values (typically \< 0.9) suggest narrowing or blockage of the arteries in the legs.
Unit of Measure: ratio | Baseline and Week 6 |
Skeletal Muscle Mass | Assessed using Bioelectrical Impedance Analysis (BIA). Represents the total weight of muscle tissue attached to the skeleton. Unit of Measure: kg | Baseline and Week 6 |
Total Body Fat Mass | Assessed using BIA. Represents the total weight of adipose tissue in the body. Unit of Measure: kg | Baseline and Week 6 |
Body Fat Percentage | Assessed using BIA. The proportion of fat mass relative to total body weight. Unit of Measure: % | Baseline and Week 6 |
Extracellular Water to Total Body Water Ratio (ECW/TBW) | Assessed using BIA. An indicator of body fluid balance and edema. Higher values may indicate fluid retention or inflammation.
Unit of Measure: ratio | Baseline and Week 6 |
Skeletal Muscle Mass Index (SMI) | Calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m\^2). Used to assess sarcopenia status.
Unit of Measure: kg/m\^2 | Baseline and Week 6 |
Phase Angle | Assessed by BIA. It reflects cellular membrane integrity and nutritional status. Higher values generally indicate better cellular health.
Unit of Measure: degree | Baseline and Week 6 |
Pre-ejection Period (PEP) | Time interval from the onset of ventricular depolarization (QRS complex) to the beginning of ejection. Reflects myocardial contractility. Unit of Measure: ms | Baseline and Week 6 |
Left Ventricular Ejection Time (ET) | The duration of blood flow ejection from the left ventricle into the aorta. Unit of Measure: ms | Baseline and Week 6 |
Heart Rate Corrected Ejection Time (ETc) | Ejection time adjusted for heart rate, typically using Bazett's formula. Unit of Measure: ms | Baseline and Week 6 |
Upstroke Time (UT) | Time from the foot to the peak of the pulse volume waveform. A marker for arterial stiffness or stenosis.
Unit of Measure: ms | Baseline and Week 6 |
ET/PEP Ratio | The ratio of ejection time (ET) to pre-ejection period (PEP). An index of left ventricular performance and efficiency.
Unit of Measure: ratio | Baseline and Week 6 |
Percent Mean Arterial Pressure (%MAP) | The position of mean arterial pressure relative to the pulse pressure range. Used as an indicator of the pulse wave shape and vascular aging.
Unit of Measure: % | Baseline and Week 6 |
Mean Arterial Pressure (MAP) | The average pressure in a patient's arteries during one cardiac cycle. Unit of Measure: mmHg | Baseline and Week 6 |
Pulse Pressure (PP) | The difference between systolic and diastolic blood pressure. It is a marker of arterial stiffness.
Unit of Measure: mmHg | Baseline and Week 6 |
Peak Torque (Knee Extension/Flexion) | The maximum torque produced during isokinetic knee extension and flexion. Assessed at a 60°/s angular velocity.
Unit of Measure: Nm (Newton-meters) | Baseline and Week 6 |
Total Work Done | The total amount of work performed by the muscle groups during the test protocol at an angular velocity of 180°/s.
Unit of Measure: Nm | Baseline and Week 6 |
Fatigue Index | The percentage decline in peak torque calculated from the difference between the initial and final repetitions during a set of isokinetic contractions performed at an angular velocity of 180°/s.
Unit of Measure: % | Baseline and Week 6 |
Hamstring-Quadriceps Ratio (H/Q Ratio) | The ratio of the peak torque of the hamstring muscles to the peak torque of the quadriceps muscles measured at an angular velocity of 60°/s.
Unit of Measure: ratio | Baseline and Week 6 |
Bilateral Deficit | The percentage difference between the sum of peak torques produced by each leg individually and the peak torque produced when both legs act simultaneously, measured at an angular velocity of 60°/s.
Unit of Measure: % | Baseline and Week 6 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
50 Years
참여 가능한 성별
여성
건강한 참가자 허용
네
- Post-menopausal women (defined as cessation of menstruation for at least 12 months).
- Aged between 50 and 70 years.
- Sedentary lifestyle (no participation in regular resistance training programs within the last 6 months).
- Able to perform lower body resistance exercise with LB-EMS suit.
- Willing to participate in the study and provide informed consent.
- Contraindications for WB-EMS: Presence of implanted electrical devices (e.g., pacemakers, defibrillators), severe bleeding disorders (e.g., hemophilia), abdominal/inguinal hernia, or history of surgery within the last 6 months (including stent insertion).
- Severe Chronic Diseases: Diagnosis of severe cardiovascular (e.g., MI, heart failure, arrhythmia), renal, neurological (e.g., epilepsy), or oncological diseases (currently undergoing treatment).
- Uncontrolled Cardiovascular Conditions: Uncontrolled hypertension or severe arterial circulatory disorders.
- Confounding Medications: Current use of hormone replacement therapy (HRT) for menopause or medications for severe psychiatric disorders (e.g., depression, anxiety).
- Acute Conditions & Others: Acute infection/inflammation, influence of alcohol/drugs, or any other condition deemed unsuitable by the investigator.
서울대학교연구 책임자
Kyungho Kim, 책임연구자, Principal Investigator, Seoul National University
연구 대표 연락처
연락처: Kyungho Kim, MS, 82 + 010-3589-8202, [email protected]
1 1개국에 임상시험 장소
Seoul
Seoul National University, Seoul, Seoul, 08826, South Korea
Kyungho Kim, MS, 연락처, 82 + 010-3589-8202, [email protected]
모집중