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O estudo clínico NCT07385534 (LB-EMS-PMW) para Sarcopenia, Arteriosclerose, Arterial Stiffness, Blood Pressure, Mulheres pós-menopausa está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Effects of Lower Body EMS Training in Postmenopausal Women (LB-EMS-PMW) 39 Randomizado Exercício

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O estudo clínico NCT07385534 (LB-EMS-PMW) é um estudo intervencionista para Sarcopenia, Arteriosclerose, Arterial Stiffness, Blood Pressure, Mulheres pós-menopausa. Seu status atual é: em recrutamento. O estudo começou em 26 de dezembro de 2025 e pretende incluir 39 participantes. Coordenado por a Universidade Nacional de Seul e deve ser concluído em 26 de maio de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 4 de fevereiro de 2026.
Resumo
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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Título oficial

Effects of Lower Body Electrical Muscle Stimulation Training on Body Composition, Muscle Function, and Arteriosclerosis Markers in Postmenopausal Women

Condições médicas
SarcopeniaArterioscleroseArterial Stiffness, Blood PressureMulheres pós-menopausa
Outros IDs do estudo
  • LB-EMS-PMW
  • IRB No. 2601/002-017
Número NCT
NCT07385534
Data de início (real)
2025-12-26
Última atualização postada
2026-02-04
Data de conclusão (estimada)
2026-05-26
Inscrição (estimada)
39
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Electrical Muscle Stimulation
EMS
Resistance Training
Postmenopausal Women
Body Composition
Vascular Health
Muscle Function
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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 ativoResistance 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
Nenhuma intervençãoControl Group
Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period.
N/A
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
50 Years
Sexos elegíveis
Feminino
Aceita voluntários saudáveis
Sim
  • 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.
Seoul National University logoUniversidade Nacional de Seul
Responsável pelo estudo
Kyungho Kim, Investigador principal, Principal Investigator, Seoul National University
Contato central do estudo
Contato: Kyungho Kim, MS, 82 + 010-3589-8202, [email protected]
1 Locais do estudo em 1 países

Seoul

Seoul National University, Seoul, Seoul, 08826, South Korea
Kyungho Kim, MS, Contato, 82 + 010-3589-8202, [email protected]
Em recrutamento