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Completed

NCT Number: NCT07628790

Feasibility of Lower-Body EMS Resistance Training in Postmenopausal Women

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.

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Key information

Conditions

Post Menopausal Autonomic Function Behavior Body Composition Motor Activity Resistance Exercise

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, 08826, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Lower-Body EMS combined with Resistance Training

Device

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 training

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline and Week 6

    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

Secondary outcomes

  1. Skeletal Muscle Mass Index (SMI)

    Time frame: Baseline and Week 6

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

  2. Total Body Muscle Mass

    Time frame: Baseline and Week 6

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

  3. Total Leg Muscle Mass

    Time frame: Baseline and Week 6

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

  4. Body Fat Percentage

    Time frame: Baseline and Week 6

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

  5. Total Body Fat Mass

    Time frame: Baseline and Week 6

    Absolute total body fat in kilograms. Unit: kg

  6. Estimated Visceral Fat Area (eVFA)

    Time frame: Baseline and Week 6

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

  7. Waist Circumference

    Time frame: Baseline and Week 6

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

  8. Waist-to-Hip Ratio (WHR)

    Time frame: Baseline and Week 6

    Waist circumference divided by hip circumference. Unit: ratio

  9. Body Mass Index (BMI)

    Time frame: Baseline and Week 6

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

  10. Phase Angle

    Time frame: Baseline and Week 6

    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

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: ratio

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

    Time frame: Baseline and Week 6

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

    Unit: ratio

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

    Time frame: Baseline and Week 6

    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

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: Nm/kg

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

    Time frame: Baseline and Week 6

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

    Unit: cm/s

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

    Time frame: Baseline and Week 6

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

  23. Brachial Systolic Blood Pressure (SBP)

    Time frame: Baseline and Week 6

    Brachial systolic blood pressure. Unit: mmHg

  24. Brachial Diastolic Blood Pressure (DBP)

    Time frame: Baseline and Week 6

    Brachial diastolic blood pressure. Unit: mmHg

  25. Pulse Pressure (PP)

    Time frame: Baseline and Week 6

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

  26. Mean Arterial Pressure (MAP)

    Time frame: Baseline and Week 6

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

  27. Average Ankle-Brachial Index (ABI)

    Time frame: Baseline and Week 6

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

  28. Augmentation Index (AI)

    Time frame: Baseline and Week 6

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

  29. Root Mean Square of Successive Differences (RMSSD)

    Time frame: Baseline and Week 6

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

    Unit: ms

  30. High-Frequency (HF) Power

    Time frame: Baseline and Week 6

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

    Unit: ms²

  31. Standard Deviation of NN Intervals (SDNN)

    Time frame: Baseline and Week 6

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

    Unit: ms

  32. Low-Frequency (LF) Power

    Time frame: Baseline and Week 6

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

  33. LF/HF Ratio

    Time frame: Baseline and Week 6

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

  34. High-Frequency Normalized Units (HFnu)

    Time frame: Baseline and Week 6

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

  35. Low-Frequency Normalized Units (LFnu)

    Time frame: Baseline and Week 6

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

  36. Total Power (TP)

    Time frame: Baseline and Week 6

    Total spectral power up to 0.4 Hz. Unit: ms²

  37. Very-Low-Frequency (VLF) Power

    Time frame: Baseline and Week 6

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

Other outcomes

  1. Dominant Knee Extensor Fatigue Index at 180°/s

    Time frame: Baseline and Week 6

    Percentage decline in knee extensor torque across the repetition set at 180°/sec on the dominant limb.

    Unit: %

  2. Non-dominant Knee Extensor Fatigue Index at 180°/s

    Time frame: Baseline and Week 6

    Percentage decline in knee extensor torque across the repetition set at 180°/sec on the non-dominant limb.

    Unit: %

  3. Dominant Knee Flexor Fatigue Index at 180°/s

    Time frame: Baseline and Week 6

    Percentage decline in knee flexor torque across the repetition set at 180°/sec on the dominant limb.

    Unit: %.

  4. Non-dominant Knee Flexor Fatigue Index at 180°/s

    Time frame: Baseline and Week 6

    Percentage decline in knee flexor torque across the repetition set at 180°/sec on the non-dominant limb.

    Unit: %

  5. Bilateral Deficit of Knee Extensors at 60°/s

    Time frame: Baseline and Week 6

    Percentage asymmetry of knee extensor peak torque between dominant and non-dominant limbs at 60°/sec.

    Unit: %

  6. Bilateral Deficit of Knee Flexors at 60°/s

    Time frame: Baseline and Week 6

    Percentage asymmetry of knee flexor peak torque between dominant and non-dominant limbs at 60°/sec.

    Unit: %

  7. Dominant Total Work Done H/Q Ratio at 180°/s

    Time frame: Baseline and Week 6

    Ratio of knee flexor to knee extensor total work done at 180°/sec on the dominant limb.

    Unit: ratio

  8. Non-dominant Total Work Done H/Q Ratio at 180°/s

    Time frame: Baseline and Week 6

    Ratio of knee flexor to knee extensor total work done at 180°/sec on the non-dominant limb.

    Unit: ratio

  9. Arterial Elasticity (AE)

    Time frame: Baseline and Week 6

    Arterial elasticity index derived from second-derivative photoplethysmography. Unit: unitless

  10. Peripheral Elasticity (PE)

    Time frame: Baseline and Week 6

    Peripheral elasticity index derived from second-derivative photoplethysmography.

    Unit: unitless.

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study 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

Acronym: LB-EMS-Pilot

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jul 28, 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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