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Universidad Nacional de SeúlEffects of Lower Body EMS Training in Postmenopausal Women (LB-EMS-PMW) 39 Aleatorizado Ejercicio
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07385534 (LB-EMS-PMW) es un estudio intervencionista para Sarcopenia, Arteriosclerosis, Arterial Stiffness, Blood Pressure, Mujeres postmenopáusicas. Su estado actual es: reclutando. El estudio se inició el 26 de diciembre de 2025, con el objetivo de reclutar a 39 participantes. Dirigido por la Universidad Nacional de Seúl, se espera que finalice el 26 de mayo de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 4 de febrero de 2026.
Resumen
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...
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Effects of Lower Body Electrical Muscle Stimulation Training on Body Composition, Muscle Function, and Arteriosclerosis Markers in Postmenopausal Women
Condiciones médicas
SarcopeniaArteriosclerosisArterial Stiffness, Blood PressureMujeres postmenopáusicasOtros ID del estudio
- LB-EMS-PMW
- IRB No. 2601/002-017
Número del NCT
Inicio del estudio (real)
2025-12-26
Última actualización
2026-02-04
Fecha de finalización (estimada)
2026-05-26
Inscripción (prevista)
39
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
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
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalLower 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 |
Comparador activoResistance 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 |
Sin intervenciónControl Group Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period. | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
50 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
Sí
- 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.
Universidad Nacional de SeúlParte responsable del estudio
Kyungho Kim, Investigador principal, Principal Investigator, Seoul National University
Contactos centrales del estudio
Contacto: Kyungho Kim, MS, 82 + 010-3589-8202, [email protected]
1 Centros del estudio en 1 países
Seoul
Seoul National University, Seoul, Seoul, 08826, South Korea
Kyungho Kim, MS, Contacto, 82 + 010-3589-8202, [email protected]
Reclutando