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Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Institute on Aging (NIA).   Recruitment status was  Recruiting

First Received on March 8, 2007.   Last Updated on December 10, 2009   History of Changes
Sponsor: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00446394
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Dementia
 Behavioral: Resources and Activities for Life Long Independence (RALLI)
Behavioral: Social Walking program (SW)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise & Health Promotion for MCI: A Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Dementia Exercise and Physical Fitness Mild Cognitive Impairment
U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in cognitive status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in health, affective, and functional status [ Time Frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: June 2007
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446394

Contacts
Contact: June van Leynseele, MA 206-221-3857 juneva@u.washington.edu
Contact: Linda Teri, PhD 206-543-0715 lteri@u.washington.edu

Locations
United States, Washington
Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Linda Teri, PhD            
Sub-Investigator: Rebecca Logsdon, PhD            
Sub-Investigator: Susan M. McCurry, PhD            
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Linda Teri, PhD University of Washington School of Nursing
  More Information

No publications provided

Responsible Party: Linda Teri, PhD, Northwest Research Group on Aging, University of Washington School of Nursing
ClinicalTrials.gov Identifier: NCT00446394     History of Changes
Other Study ID Numbers: IA0100, 2R01AG014777
Study First Received: March 8, 2007
Last Updated: December 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
cognition disorder
functional ability
psychomotor function
psychopathology
quality of life

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 13, 2012



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