Status:
COMPLETED
The LIFE Study: Lifestyle Interventions and Independence for Elders, Pilot
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Physically Challenged
Aging
Eligibility:
All Genders
70-89 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to gather preliminary data that will determine the feasibility of conducting a Phase III, randomized, controlled trial (RCT) that will provide definite evidence in the use...
Detailed Description
As the life expectancy of older Americans increases, prevention of age-associated physical function decline and disabilities has emerged as a major clinical and public health priority. A critical fact...
Eligibility Criteria
Inclusion
- Men and women ages 70 to 89
- Residency in the area for at least 9 months in the next year
- Summary score of under 10 on the Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance battery; ability to complete the 400 m walk test within 15 minutes without sitting and without the use of an assistive device (including a cane) or the help of another person
- Able to understand and perform the required study procedures; no diagnosis of dementia
- Sedentary lifestyle, i.e., has spent less than 20 minutes per week in the past month getting regular physical activity
- Willing to give informed consent, willing to be randomized to either intervention, and to follow the protocol for the group to which they have been assigned
- Successful completion of the behavioral run-in
Exclusion
- Potential difficulty adhering to either intervention
- Unable or unwilling to give informed consent or accept randomization
- Participation may be unsafe
- Serious health conditions that would interfere with the intervention goals
- Already physically active to a degree that the adoption of an activity program would be of little additional benefit
- Self-reported inability to walk two blocks
- Use of walker or assistive device to complete the 400 m walk
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT00116194
Start Date
April 1 2004
End Date
January 1 2006
Last Update
March 25 2010
Active Locations (4)
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1
Stanford University
Palo Alto, California, United States, 27157
2
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
4
Cooper Institute
Dallas, Texas, United States, 75230