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Completed

NCT Number: NCT07385534

Effects of Lower Body EMS Training in Postmenopausal Women

This study evaluates the effects of a 8-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 conditions, participation rates among postmenopausal women are often low. This study investigates whether applying EMS during lower body resistance exercises provides superior benefits compared to resistance training alone or no intervention.

Participants will be randomized into three groups:

1. Lower-body EMS combined with Resistance Training Group 2. Resistance Training Only Group 3. Control Group (No intervention)

The study aims to verify the efficacy of EMS as a time-efficient and effective alternative exercise modality for improving vascular and musculoskeletal health in this population.

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Key information

Conditions

Sarcopenia Arterial Occlusive Diseases Arterial Stiffness, Blood Pressure Arteriosclerosis Atrophy Body Composition Cardiovascular Diseases Muscle Function Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postmenopausal Women Signs and Symptoms Vascular Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, 08826, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lower-body Electromyostimulation (LB-EMS) device

Device

Electrical stimulation applied to the lower body muscles (85Hz, 350µs) during the main exercise phase

Lower Body Resistance Training

Behavioral

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

Primary outcomes

  1. Body Fat Percentage

    Time frame: Baseline and Week 8

    Assessed using BIA. The proportion of fat mass relative to total body weight. Unit of Measure: %

Secondary outcomes

  1. Highest Brachial-ankle Pulse Wave Velocity (baPWV)

    Time frame: Baseline and Week 8

    An indicator of arterial stiffness. Higher values indicate stiffer arteries. Unit of Measure: cm/s

  2. Peak Torque (Knee Extension/Flexion) per body weight

    Time frame: Baseline and Week 8

    The maximum torque produced during isokinetic knee extension and flexion. Assessed at a 60°/s angular velocity.

    Unit of Measure: Nm (Newton-meters)/kg

  3. Skeletal Muscle Mass

    Time frame: Baseline and Week 8

    Assessed using Bioelectrical Impedance Analysis (BIA). Represents the total weight of muscle tissue attached to the skeleton. Unit of Measure: kg

  4. Total Body Fat Mass

    Time frame: Baseline and Week 8

    Assessed using BIA. Represents the total weight of adipose tissue in the body. Unit of Measure: kg

  5. Skeletal Muscle Mass Index (SMI)

    Time frame: Baseline and Week 8

    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

  6. Waist Circumference

    Time frame: Baseline and Week 8

    Measured at the midpoint between the lowest rib and the iliac crest using a standard anthropometric tape, with the participant standing and breathing normally.

    Unit of Measure: cm

  7. Waist-to-Hip Ratio (WHR)

    Time frame: Baseline and Week 8

    Calculated as waist circumference divided by hip circumference. An indicator of central adiposity and cardiometabolic risk.

    Unit of Measure: ratio

  8. Estimated Visceral Fat Area (eVFA)

    Time frame: Baseline and Week 8

    Assessed using BIA. Represents the cross-sectional area of visceral adipose tissue surrounding the abdominal organs.

    Unit of Measure: cm^2

  9. Average Brachial-ankle Pulse Wave Velocity (baPWV)

    Time frame: Baseline and Week 8

    An indicator of arterial stiffness. Average values indicate stiffer arteries. Unit of Measure: cm/s

  10. Ankle-Brachial Index (ABI)

    Time frame: Baseline and Week 8

    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

  11. Systolic Blood Pressure (SBP)

    Time frame: Baseline and Week 8

    Measured using an automated oscillometric device after at least 5 minutes of seated rest. Represents the peak arterial pressure during ventricular contraction.

    Unit of Measure: mmHg

  12. Diastolic Blood Pressure (DBP)

    Time frame: Baseline and Week 8

    Measured using an automated oscillometric device after at least 5 minutes of seated rest. Represents the minimum arterial pressure during ventricular relaxation.

    Unit of Measure: mmHg

  13. Pulse Pressure (PP)

    Time frame: Baseline and Week 8

    The difference between systolic and diastolic blood pressure. It is a marker of arterial stiffness.

    Unit of Measure: mmHg

  14. Mean Arterial Pressure (MAP)

    Time frame: Baseline and Week 8

    Calculated as (SBP + 2 × DBP) / 3. Represents the average arterial pressure during one cardiac cycle.

    Unit of Measure: mmHg

  15. Total Work Done per body weight

    Time frame: Baseline and Week 8

    The total amount of work performed by the muscle groups during the test protocol(Knee extension/flexion) at an angular velocity of 180°/s.

    Unit of Measure: Nm/kg

Other outcomes

  1. Fatigue Index

    Time frame: Baseline and Week 8

    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: %

  2. Hamstring-Quadriceps Ratio (H/Q Ratio)

    Time frame: Baseline and Week 8

    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

  3. Bilateral Deficit

    Time frame: Baseline and Week 8

    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: %

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study title

Effects of Lower-Body Electrical Muscle Stimulation Combined With Resistance Training on Body Composition, Muscle Function, and Arteriosclerosis-related Markers in Postmenopausal Women: A Three-arm Randomized Controlled Trial

Acronym: LB-EMS-PMW

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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