Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 7:20 PM
Study NCT ID:
NCT04439734
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2020-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Whole-body Electromyostimulation on Golf Performance in Amateur Golfers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor were unaware of participants status (i.e. WB-EMS or control) and were not allowed to ask correspondingly'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with two study groups in parallel: (1) Whole body electromyostimulation (WB-EMS) or 16 weeks (b) non WB-EMS control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clubhead speed', 'timeFrame': 'At baseline and after16 weeks (i.e. over 16 weeks)', 'description': 'Changes of clubhead speed as determined by a radar-based system ("TrackMan", Scottsdale, USA)'}], 'secondaryOutcomes': [{'measure': 'Trunk stability as determined by', 'timeFrame': 'At baseline and after16 weeks (i.e. over 16 weeks)', 'description': 'Changes of maximum isometric trunk strength (index of trunk extension/-flexion; lateral flexion and trunk rotation) as determined by an isometric testing device'}, {'measure': 'Clubhead speed', 'timeFrame': 'At baseline and after 8 weeks (i.e. over 8 weeks)', 'description': 'Changes of clubhead speed as determined by a radar-based system ("TrackMan", Scottsdale, USA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Athletic Performance']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zink C, Rückel F, von Stengel S, Kemmler W. The Use of Whole Body Electromyostimulation (WB-EMS) as a Golf Warm-Up - A Randomized Controlled Cross-Over Study. Archives of Physical Health and Sports Medicine 2019; 2(1)1: 04-12'}]}, 'descriptionModule': {'briefSummary': 'Golf is becoming increasingly popular in Germany. However, the biomechanical and motor challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers carry out serious preparation and conditioning as part of a strength/stabilization program. The main argument for this limitation is the aspect of "limited time resources". A solution to this problem could therefore be the time-effective and highly individualizable whole-body electromyostimulation (WB-EMS) technology.\n\nThe aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMS application on trunk stability and clubhead speed in male amateur golfers in a (randomized) controlled setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Golfhandicap ≤20,\n* members of the Golfclub München-Eichenried\n\nExclusion Criteria:\n\n* diseases and medication that did not allow WB-EMS training (see contraindications WB-EMS) or enable proper assessment of clubhead speed (in cases of doubt, individual medical decision),\n* resistance and/or WB-EMS Training during the last 6 months,\n* more than two expected missed WB-EMS sessions'}, 'identificationModule': {'nctId': 'NCT04439734', 'briefTitle': 'Effects of Whole-body Electromyostimulation on Golf Performance in Amateur Golfers', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effects of Whole-body Electromyostimulation on Clubhead Speed and Stability in Ambitious Amateur Golfers - a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'GOLFEMS III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole-Body Electromyostimulation', 'description': 'WB-EMS once per week for for 16 week (85 Hz, 350 µs, bipolar, duty cycle 4s-4s)', 'interventionNames': ['Device: Electromyostimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Non WB-EMS control', 'description': 'No WB intervention, but maintained physical activity and habitual exercise habits'}], 'interventions': [{'name': 'Electromyostimulation', 'type': 'DEVICE', 'description': 'WB-EMS once per week 20 min for 16 weeks', 'armGroupLabels': ['Whole-Body Electromyostimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will become available in January 2021 without time limit', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study are available on request from the corresponding author (WK)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Golfersworld München', 'class': 'UNKNOWN'}, {'name': 'Golfclub München-Eichenried', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}