The LIFE Study: Lifestyle Interventions and Independence for Elders, Pilot

Completed · Phase 1/Phase 2

Conditions studied: Physically Challenged, Aging

In brief

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 of physical exercise to prevent mobility disability in older persons.

Key facts

Study ID

NCT00116194

Run by

National Institute on Aging (NIA)

People needed

424

Starts

2004-04-01

Expected to finish

2006-01-01

Last updated by the study team

2010-03-25

Who can join

Age: 70 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Cooper Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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