The Influence of Exercise on Mental Health After Discharge From Hospital
| Tracking Information | |||||
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| First Received Date ICMJE | September 10, 2010 | ||||
| Last Updated Date | August 23, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Health-related quality of life. Short form Health Survey (SF-36, version 2 [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01204567 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Senior fitness test, Cognitive capacity, PASE [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Influence of Exercise on Mental Health After Discharge From Hospital | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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. Design: 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. Outcome measure: Health-related quality of life Physical function Cognitive capacity Physical activity Body composition Physical activity level |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Quality of Life | ||||
| Intervention ICMJE | Other: Aerobic training
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.
Other Names:
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| Study Arm (s) | Active Comparator: Training follow-up after discharge
Aerobic training Home-program
Intervention: Other: Aerobic training |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 116 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 70 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01204567 | ||||
| Other Study ID Numbers ICMJE | 2009/184a | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Oslo University Hospital | ||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||
| Collaborators ICMJE | Oslo University College | ||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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