Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:41 PM
Study NCT ID:
NCT07385534
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lower Body EMS Training in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel-group design with three arms: 1) Lower Body EMS combined with Resistance Training, 2) Resistance Training alone, and 3) Control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial-ankle Pulse Wave Velocity (baPWV)', 'timeFrame': 'Baseline and Week 6', 'description': 'An indicator of arterial stiffness. Higher values indicate stiffer arteries. Unit of Measure: cm/s'}], 'secondaryOutcomes': [{'measure': 'Ankle-Brachial Index (ABI)', 'timeFrame': 'Baseline and Week 6', 'description': '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.\n\nUnit of Measure: ratio'}, {'measure': 'Skeletal Muscle Mass', 'timeFrame': 'Baseline and Week 6', 'description': 'Assessed using Bioelectrical Impedance Analysis (BIA). Represents the total weight of muscle tissue attached to the skeleton. Unit of Measure: kg'}, {'measure': 'Total Body Fat Mass', 'timeFrame': 'Baseline and Week 6', 'description': 'Assessed using BIA. Represents the total weight of adipose tissue in the body. Unit of Measure: kg'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Baseline and Week 6', 'description': 'Assessed using BIA. The proportion of fat mass relative to total body weight. Unit of Measure: %'}, {'measure': 'Extracellular Water to Total Body Water Ratio (ECW/TBW)', 'timeFrame': 'Baseline and Week 6', 'description': 'Assessed using BIA. An indicator of body fluid balance and edema. Higher values may indicate fluid retention or inflammation.\n\nUnit of Measure: ratio'}, {'measure': 'Skeletal Muscle Mass Index (SMI)', 'timeFrame': 'Baseline and Week 6', 'description': 'Calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m\\^2). Used to assess sarcopenia status.\n\nUnit of Measure: kg/m\\^2'}, {'measure': 'Phase Angle', 'timeFrame': 'Baseline and Week 6', 'description': 'Assessed by BIA. It reflects cellular membrane integrity and nutritional status. Higher values generally indicate better cellular health.\n\nUnit of Measure: degree'}, {'measure': 'Pre-ejection Period (PEP)', 'timeFrame': 'Baseline and Week 6', 'description': 'Time interval from the onset of ventricular depolarization (QRS complex) to the beginning of ejection. Reflects myocardial contractility. Unit of Measure: ms'}, {'measure': 'Left Ventricular Ejection Time (ET)', 'timeFrame': 'Baseline and Week 6', 'description': 'The duration of blood flow ejection from the left ventricle into the aorta. Unit of Measure: ms'}, {'measure': 'Heart Rate Corrected Ejection Time (ETc)', 'timeFrame': 'Baseline and Week 6', 'description': "Ejection time adjusted for heart rate, typically using Bazett's formula. Unit of Measure: ms"}, {'measure': 'Upstroke Time (UT)', 'timeFrame': 'Baseline and Week 6', 'description': 'Time from the foot to the peak of the pulse volume waveform. A marker for arterial stiffness or stenosis.\n\nUnit of Measure: ms'}, {'measure': 'ET/PEP Ratio', 'timeFrame': 'Baseline and Week 6', 'description': 'The ratio of ejection time (ET) to pre-ejection period (PEP). An index of left ventricular performance and efficiency.\n\nUnit of Measure: ratio'}, {'measure': 'Percent Mean Arterial Pressure (%MAP)', 'timeFrame': 'Baseline and Week 6', 'description': 'The position of mean arterial pressure relative to the pulse pressure range. Used as an indicator of the pulse wave shape and vascular aging.\n\nUnit of Measure: %'}, {'measure': 'Mean Arterial Pressure (MAP)', 'timeFrame': 'Baseline and Week 6', 'description': "The average pressure in a patient's arteries during one cardiac cycle. Unit of Measure: mmHg"}, {'measure': 'Pulse Pressure (PP)', 'timeFrame': 'Baseline and Week 6', 'description': 'The difference between systolic and diastolic blood pressure. It is a marker of arterial stiffness.\n\nUnit of Measure: mmHg'}, {'measure': 'Peak Torque (Knee Extension/Flexion)', 'timeFrame': 'Baseline and Week 6', 'description': 'The maximum torque produced during isokinetic knee extension and flexion. Assessed at a 60°/s angular velocity.\n\nUnit of Measure: Nm (Newton-meters)'}, {'measure': 'Total Work Done', 'timeFrame': 'Baseline and Week 6', 'description': 'The total amount of work performed by the muscle groups during the test protocol at an angular velocity of 180°/s.\n\nUnit of Measure: Nm'}, {'measure': 'Fatigue Index', 'timeFrame': 'Baseline and Week 6', 'description': '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.\n\nUnit of Measure: %'}, {'measure': 'Hamstring-Quadriceps Ratio (H/Q Ratio)', 'timeFrame': 'Baseline and Week 6', 'description': '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.\n\nUnit of Measure: ratio'}, {'measure': 'Bilateral Deficit', 'timeFrame': 'Baseline and Week 6', 'description': '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.\n\nUnit of Measure: %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrical Muscle Stimulation', 'EMS', 'Resistance Training', 'Postmenopausal Women', 'Body Composition', 'Vascular Health', 'Muscle Function'], 'conditions': ['Sarcopenia', 'Arteriosclerosis', 'Arterial Stiffness, Blood Pressure', 'Postmenopausal Women']}, 'descriptionModule': {'briefSummary': '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.\n\nMenopause 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.\n\nParticipants will be randomized into three groups:\n\n1. Lower-body EMS combined with Resistance Training Group\n2. Resistance Training Only Group\n3. Control Group (No intervention)\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women (defined as cessation of menstruation for at least 12 months).\n* Aged between 50 and 70 years.\n* Sedentary lifestyle (no participation in regular resistance training programs within the last 6 months).\n* Able to perform lower body resistance exercise with LB-EMS suit.\n* Willing to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* 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).\n* Severe Chronic Diseases: Diagnosis of severe cardiovascular (e.g., MI, heart failure, arrhythmia), renal, neurological (e.g., epilepsy), or oncological diseases (currently undergoing treatment).\n* Uncontrolled Cardiovascular Conditions: Uncontrolled hypertension or severe arterial circulatory disorders.\n* Confounding Medications: Current use of hormone replacement therapy (HRT) for menopause or medications for severe psychiatric disorders (e.g., depression, anxiety).\n* Acute Conditions \\& Others: Acute infection/inflammation, influence of alcohol/drugs, or any other condition deemed unsuitable by the investigator.'}, 'identificationModule': {'nctId': 'NCT07385534', 'acronym': 'LB-EMS-PMW', 'briefTitle': 'Effects of Lower Body EMS Training in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University'}, 'officialTitle': 'Effects of Lower Body Electrical Muscle Stimulation Training on Body Composition, Muscle Function, and Arteriosclerosis Markers in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'IRB No. 2601/002-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lower Body EMS + Resistance Training Group', 'description': '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.', 'interventionNames': ['Device: Lower-body Electromyostimulation (LB-EMS) device', 'Behavioral: Lower Body Resistance Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resistance Training Only Group', 'description': '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.', 'interventionNames': ['Behavioral: Lower Body Resistance Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants maintain their usual daily lifestyle without engaging in any new exercise programs during the 6-week study period.'}], 'interventions': [{'name': 'Lower-body Electromyostimulation (LB-EMS) device', 'type': 'DEVICE', 'description': 'Electrical stimulation applied to the lower body muscles (85Hz, 350µs) during the main exercise phase', 'armGroupLabels': ['Lower Body EMS + Resistance Training Group']}, {'name': 'Lower Body Resistance Training', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Lower Body EMS + Resistance Training Group', 'Resistance Training Only Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08826', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyungho Kim, MS', 'role': 'CONTACT', 'email': '2007kkh@snu.ac.kr', 'phone': '82 + 010-3589-8202'}], 'facility': 'Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyungho Kim, MS', 'role': 'CONTACT', 'email': '2007kkh@snu.ac.kr', 'phone': '82 + 010-3589-8202'}], 'overallOfficials': [{'name': 'Yeon Soo Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kyungho Kim', 'investigatorAffiliation': 'Seoul National University'}}}}