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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 8, 2007 | ||||||||
| Last Updated Date | June 30, 2009 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes in cognitive status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Changes in cognitive status | ||||||||
| Change History | Complete list of historical versions of study NCT00446394 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Changes in health, affective, and functional status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Changes in health, affective, and functional status | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI) | ||||||||
| Official Title ICMJE | Exercise & Health Promotion for MCI: A Controlled Trial | ||||||||
| Brief Summary | The purpose of this project is to evaluate an exercise and health promotion program for older adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced exercise and health promotion program to determine whether it is more effective than a social walking program in delaying further memory decline, improving mood and physical function, and enhancing quality of life. |
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| Detailed Description | This project is a randomized controlled trial to evaluate the efficacy of a group exercise and health promotion program designed specifically for older adults with Mild Cognitive Impairment (MCI). This study builds upon previous studies designed for cognitively intact older adults, with a supplemental study using a modified intervention for MCI participants, and for individuals with Alzheimer's disease. Taken together, these prior investigations support the efficacy of behaviorally based exercise interventions in improving cognitive, physical, and affective status in cognitively intact and demented older adults. Results from a feasibility study suggest that these positive outcomes can also be obtained in older adults with MCI. The current study will investigate the efficacy of the modified exercise program called RALLI (Resources and Activities for Life Long Independence) to determine whether it is more effective than the control condition, a social walking program (SW), in delaying cognitive decline, improving self-rated health and health behaviors, improving affect and physical function, and enhancing quality of life. The long-term efficacy of RALLI to delay conversion of MCI to dementia, reduce physical disability, maintain independent living, and improve physiological health indicators will also be investigated. One hundred seventy participants over the age of 70 who meet American Academy of Neurology criteria for MCI will be recruited from independent living retirement residences. Participants will be randomly assigned to one of the two conditions (RALLI and SW) and assessed at baseline, post treatment (3 months), and follow up visits every 6 months for a total of 3 years (months 6, 12, 18, 24, 30, and 36). The hypothesis is that RALLI participants will experience better post-treatment outcomes than SW participants, and that gains will be maintained over 36 months. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| 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 | 170 | ||||||||
| Estimated Completion Date | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2011 (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 | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00446394 | ||||||||
| Responsible Party | Linda Teri, PhD, Northwest Research Group on Aging, University of Washington School of Nursing | ||||||||
| Study ID Numbers ICMJE | IA0100, 2R01AG014777 | ||||||||
| 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 | June 2009 | ||||||||
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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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