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

Primary Purpose

Mild Cognitive Impairment, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resources and Activities for Life Long Independence (RALLI)
Social Walking program (SW)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring cognition disorder, functional ability, psychomotor function, psychopathology, quality of life

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Changes in cognitive status

Secondary Outcome Measures

Changes in health, affective, and functional status

Full Information

First Posted
March 8, 2007
Last Updated
October 18, 2012
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00446394
Brief Title
Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)
Official Title
Exercise & Health Promotion for MCI: A Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Dementia
Keywords
cognition disorder, functional ability, psychomotor function, psychopathology, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Resources and Activities for Life Long Independence (RALLI)
Intervention Description
Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks
Intervention Type
Behavioral
Intervention Name(s)
Social Walking program (SW)
Intervention Description
Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
Primary Outcome Measure Information:
Title
Changes in cognitive status
Time Frame
baseline, 3, 6, 12, 18, 24, 30, and 36 months
Secondary Outcome Measure Information:
Title
Changes in health, affective, and functional status
Time Frame
baseline, 3, 6, 12, 18, 24, 30, and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Teri, PhD
Organizational Affiliation
University of Washington School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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

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