Trial Radar IA
Lo studio clinico NCT07385534 (LB-EMS-PMW) per Sarcopenia, Arteriosclerosi, Arterial Stiffness, Blood Pressure, Donne postmenopausali è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca

Effects of Lower Body EMS Training in Postmenopausal Women (LB-EMS-PMW) 39 Randomizzato Esercizio

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07385534 (LB-EMS-PMW) è uno studio interventistico per Sarcopenia, Arteriosclerosi, Arterial Stiffness, Blood Pressure, Donne postmenopausali, attualmente in arruolamento. Avviato il 26 dicembre 2025, prevede di arruolare 39 partecipanti. Sotto la guida di l'Università Nazionale di Seul, dovrebbe concludersi entro il 26 maggio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 4 febbraio 2026.
Sommario breve
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...

Mostra di più
Titolo ufficiale

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

Patologie
SarcopeniaArteriosclerosiArterial Stiffness, Blood PressureDonne postmenopausali
Altri ID dello studio
  • LB-EMS-PMW
  • IRB No. 2601/002-017
Numero NCT
NCT07385534
Data di inizio (effettiva)
2025-12-26
Ultimo aggiornamento pubblicato
2026-02-04
Data di completamento (stimata)
2026-05-26
Arruolamento (previsto)
39
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Electrical Muscle Stimulation
EMS
Resistance Training
Postmenopausal Women
Body Composition
Vascular Health
Muscle Function
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleLower 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
Comparatore attivoResistance 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
Nessun interventoControl Group
Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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 alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
50 Years
Sessi idonei
Femmina
Accetta volontari sani
Sì
  • 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 logoUniversità Nazionale di Seul
Parte responsabile dello studio
Kyungho Kim, Investigatore principale, Principal Investigator, Seoul National University
Contatti principali dello studio
Contatto: Kyungho Kim, MS, 82 + 010-3589-8202, [email protected]
1 Centri dello studio in 1 paesi

Seoul

Seoul National University, Seoul, Seoul, 08826, South Korea
Kyungho Kim, MS, Contatto, 82 + 010-3589-8202, [email protected]
In arruolamento