Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 9:48 AM
Study NCT ID:
NCT03306056
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2017-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel-group, randomized-controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2017-10-09', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic Syndrome Z-Score (MetS-Z-Score)', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': "MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex."}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices (Butterfly, Pull-down, Hyperextension, Abdominal Crunch, Leg-Press)'}, {'measure': 'Body Composition', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Cardiorespiratory Fitness (CRF)', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)'}, {'measure': 'Inflammation status', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Inflammation will be assessed by measuring Levels of CRP and inflammatory cytokines and other inflammatory blood markers'}, {'measure': 'Health-related quality of life', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire'}, {'measure': 'Pain scores', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)'}, {'measure': 'Perceived stress', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)'}, {'measure': 'Subjective work ability', 'timeFrame': '12 weeks (baseline to 12 week follow-up assessment)', 'description': 'Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Strength Training', 'Health Promotion', 'Inflammation', 'Body Composition'], 'conditions': ['Overweight and Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and subjective health outcomes in overweight individuals at increased cardiometabolic risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index \\>25\n* presence of at least 2 cardiometabolic risk factors\n\nExclusion Criteria:\n\n* Healthy persons or patients under age\n* Overweight persons without any additional cardiometabolic risk factors\n* Pregnancy, Lactation\n* Psychological disorders, epilepsy, sever neurological disorders\n* Participation in other exercise- or nutrition studies within the last 6 months\n* acute cardiovascular disease\n* malignant disease\n* Rheuma\n* Intake of anabolic drugs,\n* Skin injuries in the area of electrode placements\n* Electronic implants (defibrillator, pacemaker)\n* Persons in mental hospitals by order of authorities or jurisdiction'}, 'identificationModule': {'nctId': 'NCT03306056', 'acronym': 'EKAM', 'briefTitle': 'Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk', 'orgStudyIdInfo': {'id': 'EKAM-Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Nutritional therapy / no exercise', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Strength Training', 'description': 'Nutritional therapy combined with a Standard Strength Training program', 'interventionNames': ['Other: Standard Strength Training']}, {'type': 'EXPERIMENTAL', 'label': 'Low-volume Strength Training', 'description': 'Nutritional therapy combined with a low-volume Strength Training program', 'interventionNames': ['Other: Low-volume Strength Training']}, {'type': 'EXPERIMENTAL', 'label': 'Whole-body Electromyostimulation', 'description': 'Nutritional therapy combined with Whole-Body Electromyostimulation', 'interventionNames': ['Other: Whole-Body Electromyostimulation (WB-EMS)']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks', 'armGroupLabels': ['Control']}, {'name': 'Standard Strength Training', 'type': 'OTHER', 'description': 'Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program:\n\n* 5 strength training exercises (chest, upper/lower back, abdominals, legs)\n* 3 sets per exercise\n* time-effort per session: \\~90 min\n* 2 training sessions per week\n* duration of exercise intervention: 12 weeks', 'armGroupLabels': ['Standard Strength Training']}, {'name': 'Low-volume Strength Training', 'type': 'OTHER', 'description': 'Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program:\n\n* 5 strength training exercises (chest, upper/lower back, abdominals, legs)\n* 1 set per exercise\n* time-effort per session: \\~20 min\n* 2 training sessions per week\n* duration of exercise intervention: 12 weeks', 'armGroupLabels': ['Low-volume Strength Training']}, {'name': 'Whole-Body Electromyostimulation (WB-EMS)', 'type': 'OTHER', 'description': 'Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS:\n\n* time-effort per session: \\~20 min\n* duration of exercise intervention: 12 weeks', 'armGroupLabels': ['Whole-body Electromyostimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dejan Reljic, Dr.', 'role': 'CONTACT', 'email': 'dejan.reljic@uk-erlangen.de', 'phone': '+49 9131 8545218'}, {'name': 'Yurdaguel Zopf, Prof.', 'role': 'CONTACT', 'email': 'yurdaguel.zopf@uk-erlangen.de', 'phone': '+49 9131 8545218'}], 'facility': 'Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Dejan Reljic, Dr.', 'role': 'CONTACT', 'email': 'dejan.reljic@uk-erlangen.de', 'phone': '+49 9131 8545218'}, {'name': 'Yurdaguel Zopf, Prof.', 'role': 'CONTACT', 'email': 'yurdaguel.zopf@uk-erlangen.de', 'phone': '+49 9131 8545218'}], 'overallOfficials': [{'name': 'Dejan Reljic, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Erlangen Nuremberg Medical School'}, {'name': 'Yurdaguel Zopf, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Erlangen Nuremberg Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}