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临床试验/NCT07385534
NCT07385534
招募中
不适用

Effects of Lower Body Electrical Muscle Stimulation Training on Body Composition, Muscle Function, and Arteriosclerosis Markers in Postmenopausal Women

Seoul National University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年12月26日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
39
试验地点
1
主要终点
Brachial-ankle Pulse Wave Velocity (baPWV)

概览

简要总结

This study evaluates the effects of a 6-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. Lower-body EMS combined with Resistance Training Group
  2. Resistance Training Only Group
  3. Control Group (No intervention)

The study aims to verify the efficacy of EMS as a time-efficient and effective alternative exercise modality for improving vascular and musculoskeletal health in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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 6 weeks.

干预措施: Lower-body Electromyostimulation (LB-EMS) device (Device)

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 6 weeks.

干预措施: Lower Body Resistance Training (Behavioral)

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.

干预措施: Lower Body Resistance Training (Behavioral)

Control Group

No Intervention

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

结局指标

主要结局

Brachial-ankle Pulse Wave Velocity (baPWV)

时间窗: Baseline and Week 6

An indicator of arterial stiffness. Higher values indicate stiffer arteries. Unit of Measure: cm/s

次要结局

  • Ankle-Brachial Index (ABI)(Baseline and Week 6)
  • Skeletal Muscle Mass(Baseline and Week 6)
  • Total Body Fat Mass(Baseline and Week 6)
  • Body Fat Percentage(Baseline and Week 6)
  • Extracellular Water to Total Body Water Ratio (ECW/TBW)(Baseline and Week 6)
  • Skeletal Muscle Mass Index (SMI)(Baseline and Week 6)
  • Phase Angle(Baseline and Week 6)
  • Pre-ejection Period (PEP)(Baseline and Week 6)
  • Left Ventricular Ejection Time (ET)(Baseline and Week 6)
  • Heart Rate Corrected Ejection Time (ETc)(Baseline and Week 6)
  • Upstroke Time (UT)(Baseline and Week 6)
  • ET/PEP Ratio(Baseline and Week 6)
  • Percent Mean Arterial Pressure (%MAP)(Baseline and Week 6)
  • Mean Arterial Pressure (MAP)(Baseline and Week 6)
  • Pulse Pressure (PP)(Baseline and Week 6)
  • Peak Torque (Knee Extension/Flexion)(Baseline and Week 6)
  • Total Work Done(Baseline and Week 6)
  • Fatigue Index(Baseline and Week 6)
  • Hamstring-Quadriceps Ratio (H/Q Ratio)(Baseline and Week 6)
  • Bilateral Deficit(Baseline and Week 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyungho Kim

Principal Investigator

Seoul National University

研究点 (1)

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