Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT03353818
Status:
UNKNOWN
Last Update Posted:
2017-11-27
First Post:
2017-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Golf and Diabetes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C503998', 'term': 'GOLF protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'Evaluated at baseline and after 6 and 12 months', 'description': 'Change in physical activity level from baseline to end of study evaluated by 7-days wear of accelerometers.'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Evaluated at baseline and after 6 and 12 months', 'description': 'Use of validated questionaries to evaluate impact of quality of life'}, {'measure': 'Hand muscle strength', 'timeFrame': 'Evaluated at baseline and after 6 and 12 months', 'description': 'Change in hand muscle strength'}, {'measure': 'Diabetic control', 'timeFrame': 'Evaluated at baseline and after 6 and 12 months', 'description': 'Changes in diabetes related biochemistry and cardiovascular risk factors'}, {'measure': 'Adherence', 'timeFrame': 'Evaluated at baseline and after 6 and 12 months', 'description': 'Adherence evaluated with diarries'}, {'measure': 'Estimated VO2max', 'timeFrame': 'Evaluated at baseline and after 6 and 12 months', 'description': 'Two point bicycle test, where an estimated VO2 max can be calculated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This a randomised, single-blinded, controlled study that investigate if a free golf training programme will increase the physical activity of type 2 diabetes patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2-diabetes\n* Physical activity less than 8000 steps per day\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Pregnancy\n* Conditions that makes patients unfit for participation in golf'}, 'identificationModule': {'nctId': 'NCT03353818', 'briefTitle': 'Golf and Diabetes.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Golf and Diabetes Can an Introctionary Course to Golf and a Free 1-year Membership in a Golf Club Increase Physichal Activity?', 'orgStudyIdInfo': {'id': 'H-17001697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Golf', 'description': 'In three different golf clubs patients will be introduced how to play golf. They will be taught techniques and recieve basic golf equipment. A total of 1 year membership free membership in the golf clubs will be given.', 'interventionNames': ['Behavioral: Golf']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'No intervention given. No restrictions on physical activity.', 'interventionNames': ['Behavioral: No intervention']}], 'interventions': [{'name': 'Golf', 'type': 'BEHAVIORAL', 'description': 'A free golf course and free membership for one year in a golf club will be given to participants.', 'armGroupLabels': ['Golf']}, {'name': 'No intervention', 'type': 'BEHAVIORAL', 'description': 'Patients acting as controls will not be restricted in any ways.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Public Health, Research Unit and Section of General Practice, University of Aarhus, ,', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Diabetes Research, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexander Christensen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Unit for General Practice, Aarhus University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, ph.d.-student', 'investigatorFullName': 'Alexander Christensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}