Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 2:12 AM
Study NCT ID:
NCT01204567
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2010-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Exercise on Mental Health After Discharge From Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-23', 'studyFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life. Short form Health Survey (SF-36, version 2', 'timeFrame': '3 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Senior fitness test, Cognitive capacity, PASE', 'timeFrame': '3 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HLRQ', 'elderly', 'aerobic fitness', 'cognitive capacity'], 'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of aerobic fitness training on mental health (health-related quality of life),cognitive and physical capacity in older people discharge from hospital and to assess if further aerobic training at home enhances the effect.\n\nDesign: Randomized controlled trial conducted at Oslo University Hospital, department of Medicine in conjunction with Oslo University College. The subjects will be randomized into one intervention group (training group) or one control group.\n\nOutcome measure:\n\nHealth-related quality of life Physical function Cognitive capacity Physical activity Body composition Physical activity level', 'detailedDescription': 'Research has indicated that participation in a regular exercise program is an effective intervention to maintain and enhance cognitive and physical function in older individuals.Despite good evidence regarding the positive effects of exercise, a sedentary or inactive lifestyle is common among people over 65 years of old, especially among persons with chronic diseases. Research shows that good mental health and physical capacity is of vital importance for living independently in the community and we know that participation in physical activity offers good opportunities to extend years of active independent life. Nevertheless our knowledge is sparse regarding the evidence of effective programs for health promotion in groups of elderly, especially after discharge from hospital. Our knowledge is also sparse as to which intervention program is the most effective, group-based training or home- based training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 70 years or older\n* Be able to perform the Timed Up and Go test without use of assistive device\n\nExclusion Criteria:\n\n* Chronic disease with expected lifespan \\< 1 year\n* Exercise regularly more than twice a week\n* Cognitive impairment MMS \\< 24\n* Assessed by a doctor not to tolerate aerobic exercises\n* Exercise limiting cardiovascular or musculoskeletal disease'}, 'identificationModule': {'nctId': 'NCT01204567', 'briefTitle': 'The Influence of Exercise on Mental Health After Discharge From Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The Aim of the Study is to Evaluate the Effect of Aerobic Fitness Training on Mental Health (Health-related Quality of Life), Cognitive and Physical Capacity in Older People Discharged From Hospital.', 'orgStudyIdInfo': {'id': '2009/184a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Training follow-up after discharge', 'description': 'Aerobic training Home-program', 'interventionNames': ['Other: Aerobic training']}], 'interventions': [{'name': 'Aerobic training', 'type': 'OTHER', 'otherNames': ['1 intervention group', '1 control group no follow-up'], 'description': 'Group-based Aerobic Interval Training twice a week in 12 weeks, based on the Ulleval model. The Norwegian Ulleval Model is a group-based aerobic interval training program which is widely used in Scandinavian hospitals for patients with coronary disease. It is designed to improve physical capacity, body awareness and emotional well-being.', 'armGroupLabels': ['Training follow-up after discharge']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Therese Brovold, phd student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'no afflication'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}