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| Sponsored by: |
National Institute on Aging (NIA) |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00446394 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mild Cognitive Impairment Dementia |
Behavioral: Resources and Activities for Life Long Independence (RALLI) Behavioral: Social Walking program (SW) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Exercise & Health Promotion for MCI: A Controlled Trial |
| Estimated Enrollment: | 170 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Behavioral: Resources and Activities for Life Long Independence (RALLI)
Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks
|
| 2: Active Comparator |
Behavioral: Social Walking program (SW)
Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
|
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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: June van Leynseele, MA | 206-221-3857 | juneva@u.washington.edu |
| Contact: Linda Teri, PhD | 206-543-0715 | lteri@u.washington.edu |
| United States, Washington | |
| Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Principal Investigator: Linda Teri, PhD | |
| Sub-Investigator: Rebecca Logsdon, PhD | |
| Sub-Investigator: Susan M. McCurry, PhD | |
| Principal Investigator: | Linda Teri, PhD | University of Washington School of Nursing |
More Information
| Responsible Party: | Northwest Research Group on Aging, University of Washington School of Nursing ( Linda Teri, PhD ) |
| Study ID Numbers: | IA0100, 2R01AG014777 |
| Study First Received: | March 8, 2007 |
| Last Updated: | August 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00446394 |
| Health Authority: | United States: Federal Government |
|
cognition disorder functional ability psychomotor function psychopathology quality of life |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Quality of Life Central Nervous System Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
|
Nervous System Diseases |
