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治験 NCT07385534 (LB-EMS-PMW)（対象：サルコペニア、動脈硬化、Arterial Stiffness, Blood Pressure、閉経後女性）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ソウル大学校Effects of Lower Body EMS Training in Postmenopausal Women (LB-EMS-PMW) 39 無作為化 運動療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07385534 (LB-EMS-PMW) は 介入研究 臨床試験 で、サルコペニア、動脈硬化、Arterial Stiffness, Blood Pressure、閉経後女性 に関するものです。現在は 募集中 で、2025年12月26日 から開始しています。39 名の参加者 の募集が計画されています。この試験は ソウル大学校 によって主導され、2026年5月26日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月4日 です。
概要
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 condition...
もっと見る公式タイトル
Effects of Lower Body Electrical Muscle Stimulation Training on Body Composition, Muscle Function, and Arteriosclerosis Markers in Postmenopausal Women
疾患名
サルコペニア動脈硬化Arterial Stiffness, Blood Pressure閉経後女性その他の研究識別子
- LB-EMS-PMW
- IRB No. 2601/002-017
NCT番号
開始日
2025-12-26
最終更新日
2026-02-04
終了予定日
2026-05-26
目標参加者数
39
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Electrical Muscle Stimulation
EMS
Resistance Training
Postmenopausal Women
Body Composition
Vascular Health
Muscle Function
EMS
Resistance Training
Postmenopausal Women
Body Composition
Vascular Health
Muscle Function
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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 6 weeks. | Lower-body Electromyostimulation (LB-EMS) device Electrical stimulation applied to the lower body muscles (85Hz, 350µs) during the main exercise phase Lower Body Resistance Training A 50-minute session consisting of a 10-minute warm-up, 30 minutes of main lower body resistance training (4 types of machine-based exercises per session), and a 10-minute cool-down |
実薬対照薬Resistance Training Only Group 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. | Lower Body Resistance Training A 50-minute session consisting of a 10-minute warm-up, 30 minutes of main lower body resistance training (4 types of machine-based exercises per session), and a 10-minute cool-down |
非介入Control Group Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Brachial-ankle Pulse Wave Velocity (baPWV) | An indicator of arterial stiffness. Higher values indicate stiffer arteries. Unit of Measure: cm/s | Baseline and Week 6 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Ankle-Brachial Index (ABI) | 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 6 |
Skeletal Muscle Mass | Assessed using Bioelectrical Impedance Analysis (BIA). Represents the total weight of muscle tissue attached to the skeleton. Unit of Measure: kg | Baseline and Week 6 |
Total Body Fat Mass | Assessed using BIA. Represents the total weight of adipose tissue in the body. Unit of Measure: kg | Baseline and Week 6 |
Body Fat Percentage | Assessed using BIA. The proportion of fat mass relative to total body weight. Unit of Measure: % | Baseline and Week 6 |
Extracellular Water to Total Body Water Ratio (ECW/TBW) | Assessed using BIA. An indicator of body fluid balance and edema. Higher values may indicate fluid retention or inflammation.
Unit of Measure: ratio | Baseline and Week 6 |
Skeletal Muscle Mass Index (SMI) | 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 6 |
Phase Angle | Assessed by BIA. It reflects cellular membrane integrity and nutritional status. Higher values generally indicate better cellular health.
Unit of Measure: degree | Baseline and Week 6 |
Pre-ejection Period (PEP) | Time interval from the onset of ventricular depolarization (QRS complex) to the beginning of ejection. Reflects myocardial contractility. Unit of Measure: ms | Baseline and Week 6 |
Left Ventricular Ejection Time (ET) | The duration of blood flow ejection from the left ventricle into the aorta. Unit of Measure: ms | Baseline and Week 6 |
Heart Rate Corrected Ejection Time (ETc) | Ejection time adjusted for heart rate, typically using Bazett's formula. Unit of Measure: ms | Baseline and Week 6 |
Upstroke Time (UT) | Time from the foot to the peak of the pulse volume waveform. A marker for arterial stiffness or stenosis.
Unit of Measure: ms | Baseline and Week 6 |
ET/PEP Ratio | The ratio of ejection time (ET) to pre-ejection period (PEP). An index of left ventricular performance and efficiency.
Unit of Measure: ratio | Baseline and Week 6 |
Percent Mean Arterial Pressure (%MAP) | The position of mean arterial pressure relative to the pulse pressure range. Used as an indicator of the pulse wave shape and vascular aging.
Unit of Measure: % | Baseline and Week 6 |
Mean Arterial Pressure (MAP) | The average pressure in a patient's arteries during one cardiac cycle. Unit of Measure: mmHg | Baseline and Week 6 |
Pulse Pressure (PP) | The difference between systolic and diastolic blood pressure. It is a marker of arterial stiffness.
Unit of Measure: mmHg | Baseline and Week 6 |
Peak Torque (Knee Extension/Flexion) | The maximum torque produced during isokinetic knee extension and flexion. Assessed at a 60°/s angular velocity.
Unit of Measure: Nm (Newton-meters) | Baseline and Week 6 |
Total Work Done | The total amount of work performed by the muscle groups during the test protocol at an angular velocity of 180°/s.
Unit of Measure: Nm | Baseline and Week 6 |
Fatigue Index | 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 6 |
Hamstring-Quadriceps Ratio (H/Q Ratio) | 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 6 |
Bilateral Deficit | 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 6 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
女性
健康なボランティアを受け入れる
はい
- 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.
- 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.
ソウル大学校責任者
Kyungho Kim, 主任研究者, Principal Investigator, Seoul National University
試験中央連絡先
連絡先: Kyungho Kim, MS, 82 + 010-3589-8202, [email protected]
1 1カ国の場所
Seoul
Seoul National University, Seoul, Seoul, 08826, South Korea
Kyungho Kim, MS, 連絡先, 82 + 010-3589-8202, [email protected]
募集中