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| Tracking Information | |||||
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| First Received Date ICMJE | February 21, 2007 | ||||
| Last Updated Date | August 13, 2008 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Behavioral measures [ Time Frame: baseline, 6 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 NCT00438347 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
fMRI [ Time Frame: baseline, 6 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Influence of Fitness on Brain and Cognition | ||||
| Official Title ICMJE | Influence of Fitness on Brain and Cognition | ||||
| Brief Summary | The purpose of this study is to examine the effect of aerobic fitness training on human cognition, brain structure, and brain function of older adults. |
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| Detailed Description | Recent studies have shown the encouraging effects of fitness training on human cognition, and brain structure and function. Such effects are of great interest both for what may they tell us about the nature of cognitive and brain aging and also for their public health implications. This study will test the hypotheses that: 1) improvements in aerobic fitness of older adults will lead to improved performance on a variety of cognitive processes, and especially those processes that are supported by frontal regions of the brain; 2) improvements in cognitive processes due to enhanced aerobic fitness will be visible on fMRI scans, and will be similar to those of young adults; 3) improvements in aerobic fitness, over the course of a 1 year intervention, will result in increases in gray and white matter volume. One hundred forty sedentary older adults will be recruited for this study. Participants will be randomized to an aerobic exercise intervention group, or to a stretching and toning control group. Aerobic exercise sessions will be conducted three times a week for one year, beginning at a light to moderate intensity level over the first two months and progressing to a moderate to high level for the remainder of the year. The control group will meet on the same basis as the intervention group, and will participate in an organized program of stretching, limbering, and toning for the whole body that is specially designed for individuals 60 years of age and older. During this time, participants will exercise, keep a daily exercise log detailing distance walked (routes will be measured and mapped for participants), time spent in aerobic activity, degree of intensity (rating of perceived exertion), general level of affect during exercise, resting and exercise heart rates. Participants will participate in the MRI/fMRI, physiological (cardiorespiratory) and psychosocial testing prior to the beginning of the fitness training intervention, following 6 months of fitness training, and at the conclusion of the 1 year of fitness training. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | November 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00438347 | ||||
| Responsible Party | Art Kramer, PhD, Beckman Institute, University of Illinois | ||||
| Study ID Numbers ICMJE | IA0102, 5R37AG025667-02 | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | August 2008 | ||||
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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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