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Post MenopausalLB-EMS-PilotNCT07628790

Feasibility of Lower-Body EMS Resistance Training in Postmenopausal Women

A study testing Lower-Body EMS combined with Resistance Training and Resistance Training in people with Post Menopausal and Resistance Exercise, run by Seoul National University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot randomized controlled trial evaluates whether combining lower-body electrical muscle stimulation (EMS) with resistance training is feasible and beneficial for physically inactive postmenopausal women, who experience concurrent declines in muscle strength, body composition, arterial elasticity, and cardiac… Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
What is being tested?
Lower-Body EMS combined with Resistance Training and Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2026to 27 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women aged 50 to 70 years.
  • Menopause for at least 1 year with no current menstruation.
  • Physically inactive (have not participated in resistance training more than twice a week for the past 6 months)

Who cannot join

  • Currently receiving hormone replacement therapy (HRT).
  • Presence of implanted electrical medical devices.
  • Severe or uncontrolled medical conditions.
  • Any surgery within the past 6 months.
  • Acute illness with fever, infection, or active inflammation.
  • Severe peripheral arterial disease or abdominal/inguinal hernia.
  • Severe psychiatric disorders requiring medication, or current substance abuse.
  • Deemed physically or mentally unfit to participate in the exercise program by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Seoul National University

    Seoul, Seoul, 08826

Other trials in South Korea

About this study

Official title: Feasibility and Effects of Lower-Body Electrical Muscle Stimulation Resistance Training on Body Composition, Muscle Function, Arteriosclerotic Indices, and Autonomic Function in Postmenopausal Women: A Pilot Randomized Controlled Trial

This pilot randomized controlled trial evaluates whether combining lower-body electrical muscle stimulation (EMS) with resistance training is feasible and beneficial for physically inactive postmenopausal women, who experience concurrent declines in muscle strength, body composition, arterial elasticity, and cardiac autonomic balance.

Sixteen physically inactive postmenopausal women aged 50-70 years are randomly assigned (1:1) to either (A) supervised resistance training combined with lower-body EMS (applied to 6 muscle groups: lower back, lower abdomen, glutes, quadriceps, hamstrings, and calves) or (B) supervised resistance training alone. Both groups complete twelve 50-minute sessions (consisting of a 10-minute warm-up, 30-minute main exercise, and a 10-minute cool-down) over 6 weeks (twice weekly). Assessments before and after the intervention include body composition, lower-body muscle function, arterial stiffness, and 5-minute heart rate variability.

The primary aim is to determine the feasibility of the protocol(recruitment, retention, session attendance, and intervention dose delivery) to inform a future definitive trial. Preliminary estimates of intervention effects on the measured outcomes are reported as secondary aims.

Read the detailed description

BACKGROUND AND RATIONALE Postmenopausal women often experience physiological declines in muscle function, body composition, and cardiovascular health. While resistance training is an established countermeasure, maximizing its efficiency and adherence remains a challenge. Applying lower-body electrical muscle stimulation (EMS) during resistance training may enhance physiological adaptations and overall training effectiveness. This study aims to evaluate the feasibility of combining lower-body EMS with resistance training in physically inactive postmenopausal women to inform the design of a future definitive trial.

STUDY DESIGN This is a pilot randomized controlled trial. Participants will be randomly assigned to either an intervention group receiving combined lower-body EMS and resistance training or a control group receiving resistance training alone. Clinical and physiological outcomes will be assessed before and after the intervention period to evaluate preliminary effects.

PRIMARY FEASIBILITY OUTCOMES

The primary objective is to evaluate the feasibility of the study protocol. Feasibility will be determined by assessing several key components, including:

Recruitment: The ability to recruit the target population within the planned timeframe.

Retention: The proportion of participants who complete the study and post-intervention assessments.

Adherence: Participant attendance and compliance with the scheduled exercise sessions.

Intervention Fidelity: The successful delivery of the exercise intensity and EMS protocol as intended.

These components will be evaluated against pre-established progression criteria to determine whether the protocol can proceed to a larger trial or requires modification.

STATISTICAL APPROACH Feasibility outcomes will be summarized primarily using descriptive statistics. For secondary physiological and clinical outcomes, appropriate statistical methods will be utilized to estimate the preliminary effects of the intervention, comparing changes between the groups while adjusting for baseline measurements. Effect sizes and confidence intervals will be calculated to provide preliminary evidence and to assist with sample size calculations for future large-scale trials.

Being tested
Lower-Body EMS combined with Resistance Training, Resistance Training
Keywords
Electrical Muscle Stimulation, Resistance Training, Exercise, Lower Body, Neuromuscular Electrical Stimulation
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lower-Body EMS combined with Resistance TrainingDevice

    Electrical muscle stimulation (85 Hz, 350 μs, cycle 11, duty approx 1:2) applied to 6 muscle groups: lower back (erector spinae), lower abdomen, glutes, quadriceps, hamstrings, and calves.

  • Resistance TrainingBehavioural

    A 50-minute session consisting of a 10-minute warm-up, 30 minutes of main exercise (8 machine-based lower-body resistance exercises, 3 sets of 8-12 repetitions), and a 10-minute cool-down.

Study groups in NCT07628790
Study groupRoleWhat they receive
A Group: EMS + Resistance TrainingExperimentalLower-body EMS combined with 8 machine-based resistance exercises for 6 weeks, 2 sessions per week.
Receives: Device: Lower-Body EMS combined with Resistance Training; Behavioral: Resistance Training
B Group: Resistance TrainingActive comparator8 machine-based resistance exercises for 6 weeks, 2 sessions per week without EMS.
Receives: Behavioral: Resistance Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Feasibility Outcome (Recruitment, Retention, Session Attendance, and Intervention Dose Delivery)

    The primary outcome is the feasibility of the study protocol, assessed via recruitment rates, participant retention, session adherence, and targeted intervention delivery. These indicators will be evaluated against pre-defined progression criteria using descriptive statistics to determine whether to proceed with or modify the protocol for a future definitive trial.

    Unit: Percentage

    Measured: Baseline and Week 6

Secondary outcomes (37)
  1. Skeletal Muscle Mass Index (SMI)

    Appendicular skeletal muscle mass divided by height squared. Unit: kg/m².

    Measured: Baseline and Week 6

  2. Total Body Muscle Mass

    Total skeletal muscle mass of the whole body. Unit: kg

    Measured: Baseline and Week 6

  3. Total Leg Muscle Mass

    Combined left and right leg skeletal muscle mass. Unit: kg

    Measured: Baseline and Week 6

  4. Body Fat Percentage

    Body fat mass expressed as a percentage of total body weight. Unit: %

    Measured: Baseline and Week 6

  5. Total Body Fat Mass

    Absolute total body fat in kilograms. Unit: kg

    Measured: Baseline and Week 6

  6. Estimated Visceral Fat Area (eVFA)

    Estimated visceral fat area at the umbilical level. Unit: cm²

    Measured: Baseline and Week 6

  7. Waist Circumference

    Circumference measured at the level of the umbilicus. Unit: cm

    Measured: Baseline and Week 6

  8. Waist-to-Hip Ratio (WHR)

    Waist circumference divided by hip circumference. Unit: ratio

    Measured: Baseline and Week 6

  9. Body Mass Index (BMI)

    Body weight in kilograms divided by the square of height in meters. Unit: kg/m²

    Measured: Baseline and Week 6

  10. Phase Angle

    Whole-body bioimpedance phase angle derived from the arctangent of the reactance-to-resistance ratio. Marker of cellular membrane integrity and overall nutritional/health status.

    Unit: degrees

    Measured: Baseline and Week 6

  11. Dominant Knee Extensor Peak Torque per Body Weight at 60°/s

    Peak concentric knee extensor torque normalized to body weight, measured at 60°/sec angular velocity on the dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  12. Non-dominant Knee Extensor Peak Torque per Body Weight at 60°/s

    Peak concentric knee extensor torque normalized to body weight at 60°/sec on the non-dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  13. Dominant Knee Flexor Peak Torque per Body Weight at 60°/s

    Peak concentric knee flexor (hamstring) torque normalized to body weight at 60°/sec on the dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  14. Non-dominant Knee Flexor Peak Torque per Body Weight at 60°/s

    Peak concentric knee flexor torque normalized to body weight at 60°/sec on the non-dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  15. Dominant Hamstring-to-Quadriceps (H/Q) Ratio at 60°/s

    Ratio of knee flexor peak torque to knee extensor peak torque at 60°/sec on the dominant limb.

    Unit: ratio

    Measured: Baseline and Week 6

  16. Non-dominant Hamstring-to-Quadriceps (H/Q) Ratio at 60°/s

    Ratio of knee flexor peak torque to knee extensor peak torque at 60°/sec on the non-dominant limb.

    Unit: ratio

    Measured: Baseline and Week 6

  17. Dominant Total Work Done by Knee Extensor per Body Weight at 180°/s

    Total work performed by knee extensors across the test set, normalized to body weight, at 180°/sec angular velocity on the dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  18. Non-dominant Total Work Done by Knee Extensor per Body Weight at 180°/s

    Total work performed by knee extensors normalized to body weight at 180°/sec on the non-dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  19. Dominant Total Work Done by Knee Flexor per Body Weight at 180°/s

    Total work performed by knee flexors normalized to body weight at 180°/sec on the dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  20. Non-dominant Total Work Done by Knee Flexor per Body Weight at 180°/s

    Total work performed by knee flexors normalized to body weight at 180°/sec on the non-dominant limb.

    Unit: Nm/kg

    Measured: Baseline and Week 6

  21. Average Brachial-Ankle Pulse Wave Velocity (baPWV)

    Mean of left and right brachial-ankle pulse wave velocity; primary indicator of large-artery stiffness.

    Unit: cm/s

    Measured: Baseline and Week 6

  22. Highest Brachial-Ankle Pulse Wave Velocity (baPWV)

    The higher of left and right baPWV values, reflecting the most affected limb. Unit: cm/s

    Measured: Baseline and Week 6

  23. Brachial Systolic Blood Pressure (SBP)

    Brachial systolic blood pressure. Unit: mmHg

    Measured: Baseline and Week 6

  24. Brachial Diastolic Blood Pressure (DBP)

    Brachial diastolic blood pressure. Unit: mmHg

    Measured: Baseline and Week 6

  25. Pulse Pressure (PP)

    Pulse pressure calculated as systolic minus diastolic blood pressure. Unit: mmHg

    Measured: Baseline and Week 6

  26. Mean Arterial Pressure (MAP)

    Mean arterial pressure derived from systolic and diastolic blood pressure. Unit: mmHg

    Measured: Baseline and Week 6

  27. Average Ankle-Brachial Index (ABI)

    Mean of left and right ankle-brachial systolic blood pressure ratio. Unit: ratio

    Measured: Baseline and Week 6

  28. Augmentation Index (AI)

    Augmentation index derived from second-derivative photoplethysmography. Unit: unitless

    Measured: Baseline and Week 6

  29. Root Mean Square of Successive Differences (RMSSD)

    Root mean square of successive differences between adjacent normal-to-normal RR intervals.

    Unit: ms

    Measured: Baseline and Week 6

  30. High-Frequency (HF) Power

    Spectral power in the high-frequency band (0.15-0.4 Hz); index of parasympathetic (vagal) activity.

    Unit: ms²

    Measured: Baseline and Week 6

  31. Standard Deviation of NN Intervals (SDNN)

    Standard deviation of all normal-to-normal RR intervals; time-domain index of overall heart rate variability.

    Unit: ms

    Measured: Baseline and Week 6

  32. Low-Frequency (LF) Power

    Spectral power in the low-frequency band (0.04-0.15 Hz). Unit: ms²

    Measured: Baseline and Week 6

  33. LF/HF Ratio

    Ratio of low-frequency to high-frequency spectral power. Unit: ratio

    Measured: Baseline and Week 6

  34. High-Frequency Normalized Units (HFnu)

    HF power expressed in normalized units = HF / (LF + HF) × 100. Unit: n.u.

    Measured: Baseline and Week 6

  35. Low-Frequency Normalized Units (LFnu)

    LF power expressed in normalized units = LF / (LF + HF) × 100. Unit: n.u.

    Measured: Baseline and Week 6

  36. Total Power (TP)

    Total spectral power up to 0.4 Hz. Unit: ms²

    Measured: Baseline and Week 6

  37. Very-Low-Frequency (VLF) Power

    Spectral power in the very-low-frequency band (≤0.04 Hz). Unit: ms²

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start1 Jun 2026
  3. Primary completion27 Jul 2026
  4. Study completion27 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628790
Sponsor's protocol ID
SNU 26-02-085
Acronym
LB-EMS-Pilot
Status last verified
Jul 2026
First submitted
1 Jun 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Lower-Body EMS combined with Resistance Training and Resistance Training in people with Post Menopausal and Resistance Exercise, run by Seoul National University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Feasibility Outcome (Recruitment, Retention, Session Attendance, and Intervention Dose Delivery) (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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