Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 1:10 PM
Study NCT ID:
NCT06813092
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-03
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Resistance Exercise Compared to Whole-body Electromyostimulation in Young Female Dentists.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor were not aware of the group status and were not allowed to ask correspondingly'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized two-arm cross-over design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes for C-terminal telopeptide of type I collagen from pre- to 15 min post-exercise', 'timeFrame': 'Immediately pre-exercise to 15 min post exercise of a single exercise session', 'description': 'Changes for C-terminal telopeptide of type I collagen (CTX-I) serum levels from pre- to 15 min post-exercise as determined by blood samples'}], 'secondaryOutcomes': [{'measure': 'Changes for Procollagen type 1 N propeptide from pre- to 15 min post-exercise', 'timeFrame': 'Immediately pre-exercise to 15 min post exercise of a single exercise session', 'description': 'Changes for Procollagen type 1 N propeptide (P1NP) serum levels from pre- to 15 min post-exercise as determined by blood samples'}, {'measure': 'Changes for resting glucose from pre- to 15 min post-exercise', 'timeFrame': 'Immediately pr to 15 min post-exercise of a single exercise session', 'description': 'Changes for resting glucose serum levels from pre- to 15 min post-exercise as determined by blood samples'}, {'measure': 'Changes for hemoglobin A1c from pre- to 15 min post-exercise', 'timeFrame': 'Immediately pre- to 15 min post-exercise of a single exercise session', 'description': 'Changes for hemoglobin A1c (HBA1C) serum levels from pre- to 15 min post-exercise as determined by blood samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarkers', 'bone metabolism', 'exercise', 'whole-body electromyostimulation', 'female dentists'], 'conditions': ['Osteopenia', 'Cardiometabolic Conditions']}, 'referencesModule': {'references': [{'pmid': '25288444', 'type': 'BACKGROUND', 'citation': 'Kemmler W, Bebenek M, von Stengel S, Bauer J. Peak-bone-mass development in young adults: effects of study program related levels of occupational and leisure time physical activity and exercise. A prospective 5-year study. Osteoporos Int. 2015 Feb;26(2):653-62. doi: 10.1007/s00198-014-2918-8. Epub 2014 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'Due to their high workload and unfavorable working position, young female dentists are particularly at risk of cardiometabolic diseases and an early reduction in bone mineral density (BMD). With focus on the latter issue, short bouts of resistance exercise with high strain magnitude and velocity are commonly considered to be a feasible option to prevent bone loss in the early years of young adulthood. In parallel, whole-body electromyostimulation (WB-EMS) a trainings technology able address all main muscle groups simultaneously, however with dedicated exercise intensity might be a time-effective, joint friendly and safe option to maintain BMD in people unable or unmotivated to exercise conventionally. In the present study, we aim to compare the effects of a single session of WB-EMS versus high intensity, high velocity resistance exercise on biomarkers of bone formation (Procollagen type 1 N propeptide, P1NP) and resorption (C-terminal telopeptide of type I collagen, CTX-I). We hypothesize that no clinically relevant different effects on P1NP and CTX-I were determined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female dentistry students and young dentists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female dental students (\\>3rd semester) or licensed dentists\n* no competitive sports background for \\>2 years\n* normal body mass (BMI\\>18,5 and \\<25 kg/m2)\n\nExclusion Criteria:\n\n* more than one resistance exercise session per week (last 12 month)\n* whole-body electromyostimulation during the last 12 month\n* amenorrhea, oligomenorrhea'}, 'identificationModule': {'nctId': 'NCT06813092', 'acronym': 'FeDeBoMa', 'briefTitle': 'Effects of Resistance Exercise Compared to Whole-body Electromyostimulation in Young Female Dentists.', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effects of a Single Bout of High Intensity, High Velocity Resistance Exercise Compared to Whole-body Electromyostimulation on Cardiometabolic Risk Factors and Markers of Bone Formation and -Resorption in Young Female Dentists.', 'orgStudyIdInfo': {'id': 'FeDeBoMa02'}, 'secondaryIdInfos': [{'id': 'UKER', 'type': 'OTHER', 'domain': 'University Hospital Erlangen, Germany'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole-Body Electromyostimulation', 'description': 'One single bout of whole-body electromyostimulation (20 min, bipolar, 85 Hz, 350 µs, rectangular, 6s of impulse, 4s of rest)', 'interventionNames': ['Other: Whole-Body Electromyostimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resistance exercise', 'description': 'High intensity, high velocity resistance exercise (30 min, 5-6 exercises, 3 sets at 60-85% 1RM)', 'interventionNames': ['Other: Resistance exercise']}], 'interventions': [{'name': 'Whole-Body Electromyostimulation', 'type': 'OTHER', 'description': '20 min of WB-EMS (bipolar, 85 Hz, 350 µs, 6s impulse - 4s impulse break)', 'armGroupLabels': ['Whole-Body Electromyostimulation']}, {'name': 'Resistance exercise', 'type': 'OTHER', 'description': 'High-intensity/high velocity multiple set resistance exercise', 'armGroupLabels': ['Resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Institute of Radiology', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Institute of Radiology, University Hospital NErlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Wolfgang Kemmler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Erlangen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}