绝经后女性下肢EMS训练效果 (LB-EMS-PMW)
下半身电肌肉刺激训练对绝经后女性身体成分、肌肉功能和动脉粥样硬化标志物的影响
本研究评估为期6周的下半身电肌肉刺激（EMS）训练计划对绝经后女性身体成分、肌肉功能和动脉硬化标志物的影响。
绝经与雌激素的快速下降相关，这会增加肌肉减少症（肌肉流失）和动脉僵硬度（心血管疾病）的风险。 虽然抗阻训练对这些状况有效，但绝经后女性的参与率通常较低。 本研究旨在探究在下半身抗阻运动期间应用EMS是否比单独进行抗阻训练或无干预提供更优越的益处。
参与者将被随机分为三组：
- 下半身EMS结合抗阻训练组
- 仅抗阻训练组
- 对照组（无干预）
本研究旨在验证EMS作为一种时间高效且有效的替代运动方式，在改善该人群血管和肌肉骨骼健康方面的功效。
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul
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Seoul、Seoul、韩国、08826
- Seoul National University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准：
- 绝经后女性（定义为至少12个月无月经）。
- 年龄在50至70岁之间。
- 久坐生活方式（过去6个月内未参与定期抗阻训练计划）。
- 能够使用LB-EMS套装进行下肢抗阻锻炼。
- 愿意参与研究并提供知情同意书。
排除标准：
- WB-EMS禁忌症：存在植入式电子设备（如起搏器、除颤器）、严重出血性疾病（如血友病）、腹部/腹股沟疝，或过去6个月内手术史（包括支架植入）。
- 严重慢性疾病：诊断为严重心血管疾病（如心肌梗死、心力衰竭、心律失常）、肾脏疾病、神经系统疾病（如癫痫）或肿瘤疾病（目前正在接受治疗）。
- 未受控制的心血管状况：未受控制的高血压或严重动脉循环障碍。
- 干扰性药物：当前使用绝经激素替代疗法（HRT）或治疗严重精神疾病（如抑郁症、焦虑症）的药物。
- 急性状况及其他：急性感染/炎症、酒精/药物影响，或研究者认为不适合的任何其他状况。
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：仅抗阻训练组
参与者执行相同的下半身抗阻训练方案，但不进行EMS刺激。
课程结构（10分钟热身、30分钟主要练习、10分钟放松）和总时长（50分钟）与实验组相同。
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一次50分钟的课程，包括10分钟热身、30分钟的主要下肢抗阻训练（每节课进行4种器械练习）和10分钟放松
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无干预：对照组
参与者在为期6周的研究期间保持其日常生活方式，不参与任何新的运动计划。
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实验性的：Lower Body EMS + Resistance Training Group
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 8 weeks.
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在主运动阶段施加于下半身肌肉的电刺激（85Hz，350μs）
一次50分钟的课程，包括10分钟热身、30分钟的主要下肢抗阻训练（每节课进行4种器械练习）和10分钟放松
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Fat Percentage
大体时间：Baseline and Week 8
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Assessed using BIA.
The proportion of fat mass relative to total body weight.
Unit of Measure: %
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Baseline and Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Highest Brachial-ankle Pulse Wave Velocity (baPWV)
大体时间：Baseline and Week 8
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An indicator of arterial stiffness.
Higher values indicate stiffer arteries.
Unit of Measure: cm/s
|
Baseline and Week 8
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Peak Torque (Knee Extension/Flexion) per body weight
大体时间：Baseline and Week 8
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The maximum torque produced during isokinetic knee extension and flexion. Assessed at a 60°/s angular velocity. Unit of Measure: Nm (Newton-meters)/kg |
Baseline and Week 8
|
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Skeletal Muscle Mass
大体时间：Baseline and Week 8
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Assessed using Bioelectrical Impedance Analysis (BIA).
Represents the total weight of muscle tissue attached to the skeleton.
Unit of Measure: kg
|
Baseline and Week 8
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Total Body Fat Mass
大体时间：Baseline and Week 8
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Assessed using BIA.
Represents the total weight of adipose tissue in the body.
Unit of Measure: kg
|
Baseline and Week 8
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Skeletal Muscle Mass Index (SMI)
大体时间：Baseline and Week 8
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Calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m^2). Used to assess sarcopenia status. Unit of Measure: kg/m^2 |
Baseline and Week 8
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Waist Circumference
大体时间：Baseline and Week 8
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Measured at the midpoint between the lowest rib and the iliac crest using a standard anthropometric tape, with the participant standing and breathing normally. Unit of Measure: cm |
Baseline and Week 8
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Waist-to-Hip Ratio (WHR)
大体时间：Baseline and Week 8
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Calculated as waist circumference divided by hip circumference. An indicator of central adiposity and cardiometabolic risk. Unit of Measure: ratio |
Baseline and Week 8
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Estimated Visceral Fat Area (eVFA)
大体时间：Baseline and Week 8
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Assessed using BIA. Represents the cross-sectional area of visceral adipose tissue surrounding the abdominal organs. Unit of Measure: cm^2 |
Baseline and Week 8
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Average Brachial-ankle Pulse Wave Velocity (baPWV)
大体时间：Baseline and Week 8
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An indicator of arterial stiffness.
Average values indicate stiffer arteries.
Unit of Measure: cm/s
|
Baseline and Week 8
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Ankle-Brachial Index (ABI)
大体时间：Baseline and Week 8
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The Ankle-Brachial Index (ABI) is the ratio of the systolic blood pressure measured at the ankle to the systolic blood pressure measured at the brachial artery. It is a non-invasive indicator used to assess the presence and severity of peripheral arterial stenosis or occlusion. Lower ABI values (typically < 0.9) suggest narrowing or blockage of the arteries in the legs. Unit of Measure: ratio |
Baseline and Week 8
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Systolic Blood Pressure (SBP)
大体时间：Baseline and Week 8
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Measured using an automated oscillometric device after at least 5 minutes of seated rest. Represents the peak arterial pressure during ventricular contraction. Unit of Measure: mmHg |
Baseline and Week 8
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Diastolic Blood Pressure (DBP)
大体时间：Baseline and Week 8
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Measured using an automated oscillometric device after at least 5 minutes of seated rest. Represents the minimum arterial pressure during ventricular relaxation. Unit of Measure: mmHg |
Baseline and Week 8
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Pulse Pressure (PP)
大体时间：Baseline and Week 8
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The difference between systolic and diastolic blood pressure. It is a marker of arterial stiffness. Unit of Measure: mmHg |
Baseline and Week 8
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Mean Arterial Pressure (MAP)
大体时间：Baseline and Week 8
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Calculated as (SBP + 2 × DBP) / 3. Represents the average arterial pressure during one cardiac cycle. Unit of Measure: mmHg |
Baseline and Week 8
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Total Work Done per body weight
大体时间：Baseline and Week 8
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The total amount of work performed by the muscle groups during the test protocol(Knee extension/flexion) at an angular velocity of 180°/s. Unit of Measure: Nm/kg |
Baseline and Week 8
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fatigue Index
大体时间：Baseline and Week 8
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The percentage decline in peak torque calculated from the difference between the initial and final repetitions during a set of isokinetic contractions performed at an angular velocity of 180°/s. Unit of Measure: % |
Baseline and Week 8
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Hamstring-Quadriceps Ratio (H/Q Ratio)
大体时间：Baseline and Week 8
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The ratio of the peak torque of the hamstring muscles to the peak torque of the quadriceps muscles measured at an angular velocity of 60°/s. Unit of Measure: ratio |
Baseline and Week 8
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Bilateral Deficit
大体时间：Baseline and Week 8
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The percentage difference between the sum of peak torques produced by each leg individually and the peak torque produced when both legs act simultaneously, measured at an angular velocity of 60°/s. Unit of Measure: % |
Baseline and Week 8
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合作者和调查者
调查人员
- 首席研究员：Yeon Soo Kim, MD、Seoul National University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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