Feasibility of Lower-Body EMS Resistance Training in Postmenopausal Women

NCT07628790 | Recruiting

• 1 other identifier: SNU 26-02-085
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Post Menopausal; Body Composition; Autonomic Function; Resistance Exercise

Keywords

Electrical Muscle Stimulation; Resistance Training; Exercise; Lower Body; Neuromuscular Electrical Stimulation

Outcome Measures

Primary Outcomes (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

  Baseline and Week 6

Secondary Outcomes (37)

• Skeletal Muscle Mass Index (SMI)

  Baseline and Week 6

• Total Body Muscle Mass

  Baseline and Week 6

• Total Leg Muscle Mass

  Baseline and Week 6

• Body Fat Percentage

  Baseline and Week 6

• Total Body Fat Mass

  Baseline and Week 6

Other Outcomes (10)

• Dominant Knee Extensor Fatigue Index at 180°/s

  Baseline and Week 6

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

  Baseline and Week 6

• Dominant Knee Flexor Fatigue Index at 180°/s

  Baseline and Week 6

Study Arms (2)

A Group: EMS + Resistance Training

EXPERIMENTAL

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

Device: Lower-Body EMS combined with Resistance Training; Behavioral: Resistance Training

B Group: Resistance Training

ACTIVE COMPARATOR

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

Behavioral: Resistance Training

Interventions

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.

A Group: EMS + Resistance Training

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.

A Group: EMS + Resistance Training; B Group: Resistance Training

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University

Seoul, Seoul, 08826, South Korea

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yeon Soo Kim, MD, Prof

  Seoul National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyungho Kim, MS

CONTACT

82 + 010-3589-8202; 2007kkh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

KR (1)