Arterial Stiffness, Blood Pressure, Arteriosclerosis, Body Composition, Muscle Function, Postmenopausal Women, Sarcopenia
Conditions
Keywords
Electrical Muscle Stimulation, EMS, Resistance Training, Postmenopausal Women, Body Composition, Vascular Health, Muscle Function
Brief summary
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.
Interventions
DEVICELower-body Electromyostimulation (LB-EMS) device
Electrical stimulation applied to the lower body muscles (85Hz, 350µs) during the main exercise phase
BEHAVIORALLower 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
Sponsors
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A parallel-group design with three arms: 1) Lower Body EMS combined with Resistance Training, 2) Resistance Training alone, and 3) Control group.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Fat Percentage | Baseline and Week 8 | Assessed using BIA. The proportion of fat mass relative to total body weight. Unit of Measure: % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Highest Brachial-ankle Pulse Wave Velocity (baPWV) | Baseline and Week 8 | An indicator of arterial stiffness. Higher values indicate stiffer arteries. Unit of Measure: cm/s |
| Peak Torque (Knee Extension/Flexion) per body weight | 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 |
| Skeletal Muscle Mass | 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 |
| Total Body Fat Mass | Baseline and Week 8 | Assessed using BIA. Represents the total weight of adipose tissue in the body. Unit of Measure: kg |
| Skeletal Muscle Mass Index (SMI) | 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 |
| Waist Circumference | 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 |
| Waist-to-Hip Ratio (WHR) | Baseline and Week 8 | Calculated as waist circumference divided by hip circumference. An indicator of central adiposity and cardiometabolic risk. Unit of Measure: ratio |
| Estimated Visceral Fat Area (eVFA) | 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 |
| Average Brachial-ankle Pulse Wave Velocity (baPWV) | Baseline and Week 8 | An indicator of arterial stiffness. Average values indicate stiffer arteries. Unit of Measure: cm/s |
| Ankle-Brachial Index (ABI) | 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 |
| Systolic Blood Pressure (SBP) | 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 |
| Diastolic Blood Pressure (DBP) | 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 |
| Pulse Pressure (PP) | Baseline and Week 8 | The difference between systolic and diastolic blood pressure. It is a marker of arterial stiffness. Unit of Measure: mmHg |
| Mean Arterial Pressure (MAP) | Baseline and Week 8 | Calculated as (SBP + 2 × DBP) / 3. Represents the average arterial pressure during one cardiac cycle. Unit of Measure: mmHg |
| Total Work Done per body weight | 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYeon Soo Kim, MD
Seoul National University
Outcome results
None listed