Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda Teri, University of Washington
ClinicalTrials.gov Identifier:
NCT00446394
First received: March 8, 2007
Last updated: October 18, 2012
Last verified: October 2012

March 8, 2007
October 18, 2012
June 2007
October 2012   (final data collection date for primary outcome measure)
Changes in cognitive status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ]
Changes in cognitive status
Complete list of historical versions of study NCT00446394 on ClinicalTrials.gov Archive Site
Changes in health, affective, and functional status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ]
Changes in health, affective, and functional status
Not Provided
Not Provided
 
Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)
Exercise & Health Promotion for MCI: A Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Mild Cognitive Impairment
  • Dementia
  • 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
  • Behavioral: Social Walking program (SW)
    Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
  • Experimental: 1
    Intervention: Behavioral: Resources and Activities for Life Long Independence (RALLI)
  • Active Comparator: 2
    Intervention: Behavioral: Social Walking program (SW)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild Cognitive Impairment defined as
  • - Memory complaint
  • - Objective memory impairment for age and education
  • - Largely intact general cognitive function
  • - Essentially preserved activities of daily living
  • - Not already diagnosed with dementia
  • Insufficient physical activity defined as less than 150 minutes per week of moderate intensity physical activity
  • Not currently in an exercise program similar to the study program

Exclusion Criteria:

  • Not ambulatory
  • Expected to move from the study geographic area during the study period
  • Have a known terminal illness
  • Actively suicidal, hallucinating, or delusional
  • Hospitalized for a psychiatric disorder in the 12 months before baseline
  • Uncontrolled chronic conditions, e.g. uncontrolled hypertension, unstable angina, uncontrolled blood glucose
  • Blind or deaf
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00446394
30692-J, 2R01AG014777, IA0100, 06-3067-C
Yes
Linda Teri, University of Washington
University of Washington
Not Provided
Principal Investigator: Linda Teri, PhD University of Washington School of Nursing
University of Washington
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP