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.

Study Overview

• Status: Completed
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Resources and Activities for Life Long Independence (RALLI); Behavioral: Social Walking program (SW)

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in cognitive status	baseline, 3, 6, 12, 18, 24, 30, and 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in health, affective, and functional status	baseline, 3, 6, 12, 18, 24, 30, and 36 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Linda Teri, PhD, University of Washington School of Nursing

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 8, 2007
• First Submitted That Met QC Criteria: March 8, 2007
• First Posted (Estimate): March 12, 2007

Study Record Updates

• Last Update Posted (Estimate): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 18, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: cognition disorder; quality of life; psychopathology; functional ability; psychomotor function
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 30692-J; 2R01AG014777 (U.S. NIH Grant/Contract); IA0100 (Other Identifier: UW); 06-3067-C (Other Identifier: UW HSD old IRB application #)