Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)
|ClinicalTrials.gov Identifier: NCT00446394|
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : October 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Dementia||Behavioral: Resources and Activities for Life Long Independence (RALLI) Behavioral: Social Walking program (SW)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Exercise & Health Promotion for MCI: A Controlled Trial|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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
|Active Comparator: 2||
Behavioral: Social Walking program (SW)
Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
- Changes in cognitive status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ]
- Changes in health, affective, and functional status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446394
|United States, Washington|
|Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Linda Teri, PhD||University of Washington School of Nursing|