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Feasibility of Lower-Body EMS Combined With Resistance Training in Postmenopausal Women: A Pilot Randomized Controlled Trial (LB-EMS-Pilot)

1 giugno 2026 aggiornato da: Kyungho Kim, Seoul National University

Feasibility and Preliminary Effects of Lower-Body Electrical Muscle Stimulation Combined With 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Kyungho Kim, MS
Numero di telefono: 82 + 010-3589-8202
Email: 2007kkh@gmail.com

Luoghi di studio

Corea del Sud
- Seoul
  - Seoul, Seoul, Corea del Sud, 08826
    - Reclutamento
    - Seoul National University
    - Contatto:
      
      Kyungho Kim, MS
      
      Numero di telefono: 82 + 010-3589-8202
      
      Email: 2007kkh@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Altro
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Separare

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: A Group: EMS + Resistance Training Lower-body EMS combined with 8 machine-based resistance exercises for 6 weeks, 2 sessions per week.	Dispositivo: Lower-Body EMS combined with Resistance Training 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. Comportamentale: Resistance Training 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.
Comparatore attivo: B Group: Resistance Training 8 machine-based resistance exercises for 6 weeks, 2 sessions per week without EMS.	Comportamentale: Resistance Training 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.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: A Group: EMS + Resistance Training

Lower-body EMS combined with 8 machine-based resistance exercises for 6 weeks, 2 sessions per week.

Dispositivo: Lower-Body EMS combined with Resistance Training

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.

Comportamentale: Resistance Training

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.

Comparatore attivo: B Group: Resistance Training

8 machine-based resistance exercises for 6 weeks, 2 sessions per week without EMS.

Comportamentale: Resistance Training

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Composite Feasibility Outcome (Recruitment, Retention, Session Attendance, and Intervention Dose Delivery) Lasso di tempo: 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	Baseline and Week 6

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Skeletal Muscle Mass Index (SMI) Lasso di tempo: Baseline and Week 6	Appendicular skeletal muscle mass divided by height squared. Unit: kg/m².	Baseline and Week 6
Total Body Muscle Mass Lasso di tempo: Baseline and Week 6	Total skeletal muscle mass of the whole body. Unit: kg	Baseline and Week 6
Total Leg Muscle Mass Lasso di tempo: Baseline and Week 6	Combined left and right leg skeletal muscle mass. Unit: kg	Baseline and Week 6
Body Fat Percentage Lasso di tempo: Baseline and Week 6	Body fat mass expressed as a percentage of total body weight. Unit: %	Baseline and Week 6
Total Body Fat Mass Lasso di tempo: Baseline and Week 6	Absolute total body fat in kilograms. Unit: kg	Baseline and Week 6
Estimated Visceral Fat Area (eVFA) Lasso di tempo: Baseline and Week 6	Estimated visceral fat area at the umbilical level. Unit: cm²	Baseline and Week 6
Waist Circumference Lasso di tempo: Baseline and Week 6	Circumference measured at the level of the umbilicus. Unit: cm	Baseline and Week 6
Waist-to-Hip Ratio (WHR) Lasso di tempo: Baseline and Week 6	Waist circumference divided by hip circumference. Unit: ratio	Baseline and Week 6
Body Mass Index (BMI) Lasso di tempo: Baseline and Week 6	Body weight in kilograms divided by the square of height in meters. Unit: kg/m²	Baseline and Week 6
Phase Angle Lasso di tempo: 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	Baseline and Week 6
Dominant Knee Extensor Peak Torque per Body Weight at 60°/s Lasso di tempo: 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	Baseline and Week 6
Non-dominant Knee Extensor Peak Torque per Body Weight at 60°/s Lasso di tempo: Baseline and Week 6	Peak concentric knee extensor torque normalized to body weight at 60°/sec on the non-dominant limb. Unit: Nm/kg	Baseline and Week 6
Dominant Knee Flexor Peak Torque per Body Weight at 60°/s Lasso di tempo: Baseline and Week 6	Peak concentric knee flexor (hamstring) torque normalized to body weight at 60°/sec on the dominant limb. Unit: Nm/kg	Baseline and Week 6
Non-dominant Knee Flexor Peak Torque per Body Weight at 60°/s Lasso di tempo: Baseline and Week 6	Peak concentric knee flexor torque normalized to body weight at 60°/sec on the non-dominant limb. Unit: Nm/kg	Baseline and Week 6
Dominant Hamstring-to-Quadriceps (H/Q) Ratio at 60°/s Lasso di tempo: Baseline and Week 6	Ratio of knee flexor peak torque to knee extensor peak torque at 60°/sec on the dominant limb. Unit: ratio	Baseline and Week 6
Non-dominant Hamstring-to-Quadriceps (H/Q) Ratio at 60°/s Lasso di tempo: 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	Baseline and Week 6
Dominant Total Work Done by Knee Extensor per Body Weight at 180°/s Lasso di tempo: 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	Baseline and Week 6
Non-dominant Total Work Done by Knee Extensor per Body Weight at 180°/s Lasso di tempo: 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	Baseline and Week 6
Dominant Total Work Done by Knee Flexor per Body Weight at 180°/s Lasso di tempo: Baseline and Week 6	Total work performed by knee flexors normalized to body weight at 180°/sec on the dominant limb. Unit: Nm/kg	Baseline and Week 6
Non-dominant Total Work Done by Knee Flexor per Body Weight at 180°/s Lasso di tempo: 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	Baseline and Week 6
Average Brachial-Ankle Pulse Wave Velocity (baPWV) Lasso di tempo: Baseline and Week 6	Mean of left and right brachial-ankle pulse wave velocity; primary indicator of large-artery stiffness. Unit: cm/s	Baseline and Week 6
Highest Brachial-Ankle Pulse Wave Velocity (baPWV) Lasso di tempo: Baseline and Week 6	The higher of left and right baPWV values, reflecting the most affected limb. Unit: cm/s	Baseline and Week 6
Brachial Systolic Blood Pressure (SBP) Lasso di tempo: Baseline and Week 6	Brachial systolic blood pressure. Unit: mmHg	Baseline and Week 6
Brachial Diastolic Blood Pressure (DBP) Lasso di tempo: Baseline and Week 6	Brachial diastolic blood pressure. Unit: mmHg	Baseline and Week 6
Pulse Pressure (PP) Lasso di tempo: Baseline and Week 6	Pulse pressure calculated as systolic minus diastolic blood pressure. Unit: mmHg	Baseline and Week 6
Mean Arterial Pressure (MAP) Lasso di tempo: Baseline and Week 6	Mean arterial pressure derived from systolic and diastolic blood pressure. Unit: mmHg	Baseline and Week 6
Average Ankle-Brachial Index (ABI) Lasso di tempo: Baseline and Week 6	Mean of left and right ankle-brachial systolic blood pressure ratio. Unit: ratio	Baseline and Week 6
Augmentation Index (AI) Lasso di tempo: Baseline and Week 6	Augmentation index derived from second-derivative photoplethysmography. Unit: unitless	Baseline and Week 6
Root Mean Square of Successive Differences (RMSSD) Lasso di tempo: Baseline and Week 6	Root mean square of successive differences between adjacent normal-to-normal RR intervals. Unit: ms	Baseline and Week 6
High-Frequency (HF) Power Lasso di tempo: Baseline and Week 6	Spectral power in the high-frequency band (0.15-0.4 Hz); index of parasympathetic (vagal) activity. Unit: ms²	Baseline and Week 6
Standard Deviation of NN Intervals (SDNN) Lasso di tempo: Baseline and Week 6	Standard deviation of all normal-to-normal RR intervals; time-domain index of overall heart rate variability. Unit: ms	Baseline and Week 6
Low-Frequency (LF) Power Lasso di tempo: Baseline and Week 6	Spectral power in the low-frequency band (0.04-0.15 Hz). Unit: ms²	Baseline and Week 6
LF/HF Ratio Lasso di tempo: Baseline and Week 6	Ratio of low-frequency to high-frequency spectral power. Unit: ratio	Baseline and Week 6
High-Frequency Normalized Units (HFnu) Lasso di tempo: Baseline and Week 6	HF power expressed in normalized units = HF / (LF + HF) × 100. Unit: n.u.	Baseline and Week 6
Low-Frequency Normalized Units (LFnu) Lasso di tempo: Baseline and Week 6	LF power expressed in normalized units = LF / (LF + HF) × 100. Unit: n.u.	Baseline and Week 6
Total Power (TP) Lasso di tempo: Baseline and Week 6	Total spectral power up to 0.4 Hz. Unit: ms²	Baseline and Week 6
Very-Low-Frequency (VLF) Power Lasso di tempo: Baseline and Week 6	Spectral power in the very-low-frequency band (≤0.04 Hz). Unit: ms²	Baseline and Week 6

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
Dominant Knee Extensor Fatigue Index at 180°/s Lasso di tempo: Baseline and Week 6	Percentage decline in knee extensor torque across the repetition set at 180°/sec on the dominant limb. Unit: %	Baseline and Week 6
Non-dominant Knee Extensor Fatigue Index at 180°/s Lasso di tempo: Baseline and Week 6	Percentage decline in knee extensor torque across the repetition set at 180°/sec on the non-dominant limb. Unit: %	Baseline and Week 6
Dominant Knee Flexor Fatigue Index at 180°/s Lasso di tempo: Baseline and Week 6	Percentage decline in knee flexor torque across the repetition set at 180°/sec on the dominant limb. Unit: %.	Baseline and Week 6
Non-dominant Knee Flexor Fatigue Index at 180°/s Lasso di tempo: Baseline and Week 6	Percentage decline in knee flexor torque across the repetition set at 180°/sec on the non-dominant limb. Unit: %	Baseline and Week 6
Bilateral Deficit of Knee Extensors at 60°/s Lasso di tempo: Baseline and Week 6	Percentage asymmetry of knee extensor peak torque between dominant and non-dominant limbs at 60°/sec. Unit: %	Baseline and Week 6
Bilateral Deficit of Knee Flexors at 60°/s Lasso di tempo: Baseline and Week 6	Percentage asymmetry of knee flexor peak torque between dominant and non-dominant limbs at 60°/sec. Unit: %	Baseline and Week 6
Dominant Total Work Done H/Q Ratio at 180°/s Lasso di tempo: Baseline and Week 6	Ratio of knee flexor to knee extensor total work done at 180°/sec on the dominant limb. Unit: ratio	Baseline and Week 6
Non-dominant Total Work Done H/Q Ratio at 180°/s Lasso di tempo: Baseline and Week 6	Ratio of knee flexor to knee extensor total work done at 180°/sec on the non-dominant limb. Unit: ratio	Baseline and Week 6
Arterial Elasticity (AE) Lasso di tempo: Baseline and Week 6	Arterial elasticity index derived from second-derivative photoplethysmography. Unit: unitless	Baseline and Week 6
Peripheral Elasticity (PE) Lasso di tempo: Baseline and Week 6	Peripheral elasticity index derived from second-derivative photoplethysmography. Unit: unitless.	Baseline and Week 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Seoul National University

Investigatori

Investigatore principale: Yeon Soo Kim, MD, Prof, Seoul National University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

SNU 26-02-085

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Feasibility of Lower-Body EMS Combined With Resistance Training in Postmenopausal Women: A Pilot Randomized Controlled Trial (LB-EMS-Pilot)

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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Stimato)

Fase

Contatti e Sedi

Contatto studio

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Altre misure di risultato

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Investigatori

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Stimato)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

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Condizioni

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Interventi farmacologici

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Sponsor / Collaboratori

Sedi