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CompletedNCT00446394Updated Oct 19, 2012

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

An interventional study of Resources and Activities for Life Long Independence (RALLI) and Social Walking program (SW) in Mild Cognitive Impairment and Dementia, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2012-10-19.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment
  • Dementia

Keywords

  • cognition disorder
  • functional ability
  • psychomotor function
  • psychopathology
  • quality of life
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 181 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    1

    Behavioral: Resources and Activities for Life Long Independence (RALLI)

  • Active comparator
    2

    Behavioral: Social Walking program (SW)

Interventions

  • BehavioralResources 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

  • BehavioralSocial Walking program (SW)

    Group support for walking, pedometer reading, 1 hour weekly for 9 weeks

06

What researchers measure

Primary outcomes

  1. Changes in cognitive status

    Time frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months

Secondary outcomes

  1. Changes in health, affective, and functional status

    Time frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months

07

Study locations

1 site
  • Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing
    Seattle, Washington 98105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00446394
Lead sponsor
University of Washington
Responsible party
Linda Teri (Professor, University of Washington) — Principal investigator
First posted
Mar 12, 2007
Start date
Jun 2007
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Oct 19, 2012

Study contacts

Linda Teri, PhD
principal investigator · University of Washington School of Nursing

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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