Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03372005
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Floorball on Health and Performance in Subjects With Lifestyle Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-06-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Changes from baseline measured after 12 weeks and 39 weeks', 'description': 'Long term blood sugar concentration'}, {'measure': 'Blood pressure', 'timeFrame': 'Changes from baseline measured after 12 weeks and 39 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes, Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of floorball on health and performance in subjects with either type 2 diabetes or cardiovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Diagnosed with a cardiovascular disease (bp \\>140/90mmHg)\n* Physical activity \\<2 hours pr. week.\n* Not participating in any regular physical activity the last 2 years\n\nExclusion Criteria:\n\n* age \\<18 years\n* Injuries that prevent the subject from playing floorball\n* Type 1 diabetics\n* Alcohol \\>14 units pr. week.\n* Pregnancy\n* Participation in other scientific studies\n* Abuse of illegal drugs\n* other known serious diseases'}, 'identificationModule': {'nctId': 'NCT03372005', 'briefTitle': 'The Effect of Floorball on Health and Performance in Subjects With Lifestyle Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Floorball on Health Parameters and Performance in Subjects With Lifestyle Diseases', 'orgStudyIdInfo': {'id': 'Floorball'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Floorball', 'description': 'The subjects in this group are set to play floorball three times pr. week for 39 weeks.', 'interventionNames': ['Behavioral: Floorball']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group functions as a control group, that will continue the normal lifestyle throughout the study.'}], 'interventions': [{'name': 'Floorball', 'type': 'BEHAVIORAL', 'description': 'This intervention will have one week of testing before the first 12 weeks of floorball, followed by one week of testing before the last 27 week training period.', 'armGroupLabels': ['Floorball']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'August Krogh Building', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}