NCT07385534

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2025Jun 2026

Study Start

First participant enrolled

December 26, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2026

Expected
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

January 23, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

Electrical Muscle StimulationEMSResistance TrainingPostmenopausal WomenBody CompositionVascular HealthMuscle Function

Outcome Measures

Primary Outcomes (1)

  • Body Fat Percentage

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

    Baseline and Week 8

Secondary Outcomes (15)

  • Highest Brachial-ankle Pulse Wave Velocity (baPWV)

    Baseline and Week 8

  • Peak Torque (Knee Extension/Flexion) per body weight

    Baseline and Week 8

  • Skeletal Muscle Mass

    Baseline and Week 8

  • Total Body Fat Mass

    Baseline and Week 8

  • Skeletal Muscle Mass Index (SMI)

    Baseline and Week 8

  • +10 more secondary outcomes

Other Outcomes (3)

  • Fatigue Index

    Baseline and Week 8

  • Hamstring-Quadriceps Ratio (H/Q Ratio)

    Baseline and Week 8

  • Bilateral Deficit

    Baseline and Week 8

Study Arms (3)

Lower Body EMS + Resistance Training Group

EXPERIMENTAL

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 8 weeks.

Device: Lower-body Electromyostimulation (LB-EMS) deviceBehavioral: Lower Body Resistance Training

Resistance Training Only Group

ACTIVE COMPARATOR

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.

Behavioral: Lower Body Resistance Training

Control Group

NO INTERVENTION

Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period.

Interventions

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

Lower Body EMS + Resistance Training Group

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

Lower Body EMS + Resistance Training GroupResistance Training Only Group

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University

Seoul, Seoul, 08826, South Korea

Location

MeSH Terms

Conditions

SarcopeniaArteriosclerosis

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yeon Soo Kim, MD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A parallel-group design with three arms: 1) Lower Body EMS combined with Resistance Training, 2) Resistance Training alone, and 3) Control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 4, 2026

Study Start

December 26, 2025

Primary Completion

June 12, 2026

Study Completion (Estimated)

June 26, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations