Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT01680302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-09-19
First Post:
2012-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of 3 Years of Exercise on Development of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1567}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of persons who develop atrial fibrillation during the 3 year intervention period', 'timeFrame': '3 years', 'description': 'People who already have the diagnosis before randomisation will not be counted.'}], 'secondaryOutcomes': [{'measure': 'Number of persons who develop atrial fibrillation during the 6 years after randomisation', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Prevention', 'Exercise'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. The investigators will follow these persons and register all who develop atrial fibrillation during these 3 years, and at follow-up after ended intervention to see if there is differences in the number of persons who develop atrial fibrillation in the 3 groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating in the "Generation 100" study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01680302', 'briefTitle': 'Effect of 3 Years of Exercise on Development of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy', 'orgStudyIdInfo': {'id': '2012/978b-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity exercise', 'description': 'High intensity exercise(Borg 16) in intervals.', 'interventionNames': ['Behavioral: High intensity exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate intensity exercise', 'description': 'Moderate intensity exercise 3 times a week.', 'interventionNames': ['Behavioral: Moderate intensity exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Exercise on their own. Follow current guidelines.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'High intensity exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['High intensity exercise']}, {'name': 'Moderate intensity exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Moderate intensity exercise']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Advised to follow current guidelines for physical activity, but exercise on their own.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Jan Paal Loennechen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}