Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01765816
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Generation 100: Blood Volume and Cardiac Function in Healthy Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2013-01-08', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total blood volume', 'timeFrame': '24 hours', 'description': 'carbon monoxide-rebreathing spirometry (Bayreuth, Germany)'}], 'secondaryOutcomes': [{'measure': 'hemoglobin volume', 'timeFrame': '24 hours', 'description': 'carbon monoxide-rebreathing spirometry (Bayreuth, Germany)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise', 'Elderly', 'Blood volume', 'Hemoglobin'], 'conditions': ['Ageing']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ntnu.edu/cerg/generation100', 'label': 'Generation 100 web page'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.\n\nAs part of the "Generation 100" study, this sub-study project will investigate the effect of exercise on blood volume, cardiopulmonary health and heart function in healthy aging. Objective is to determine the acute effect of one endurance training session on blood volume in healthy elderly. The working hypothesis is that one interval training session increases total blood volume by 10% in healthy elderly, and that there will be no change after moderate continuous training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to walk at least 1km,\n* born in 1938,1939,1940,1941 or 1942\n* Sufficiently good health to be able to take part in the study, as determined by the researchers\n\nExclusion Criteria:\n\n* Illness or disability that precludes exercise or hinders completion of the study\n* Uncontrolled hypertension\n* Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina\n* Active cancer\n* Test results indicating that study participation is unsafe\n* Inclusion in other studies conflicting with participation in this one'}, 'identificationModule': {'nctId': 'NCT01765816', 'briefTitle': 'Generation 100: Blood Volume and Cardiac Function in Healthy Aging', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study', 'orgStudyIdInfo': {'id': 'Gen-100-sub1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high intensity interval training', 'description': 'one interval training session with 1 x 4 and 4 x 4 minutes interval training at 90-95% of peak heart rate', 'interventionNames': ['Behavioral: high intensity interval training', 'Behavioral: moderate intensity training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'moderate intensity training', 'description': '45 minutes of moderate continuous training at 75% of maximal heart rate', 'interventionNames': ['Behavioral: high intensity interval training', 'Behavioral: moderate intensity training']}], 'interventions': [{'name': 'high intensity interval training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['high intensity interval training', 'moderate intensity training']}, {'name': 'moderate intensity training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['high intensity interval training', 'moderate intensity training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Ulrik Wisløff, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}