Trial record 2 of 3 for:    Lifestyle Interventions and Independence for Elders (LIFE)

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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00116194
First received: June 27, 2005
Last updated: March 24, 2010
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Physically Challenged
Aging
Behavioral: Physical Activity
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Physical Exercise to Prevent Disability Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Combined outcome of ability to walk 400 m without the use of an assistive device or adjudicated evidence of inability to walk 400 m or death
  • Drop-in, drop-out, and loss to follow-up rates
  • Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance score
  • 4 m gait speed
  • 400 m gait speed
  • Self-reported disability scale

Secondary Outcome Measures:
  • Onset of self- or proxy-reported and objectively assessed disability in activities of daily living (ADLs)
  • Serious fall injuries
  • Combined cardiovascular events
  • Acute care hospitalizations and nursing home admissions
  • Cognitive function measures; Health-related quality of life (HRQL), as reflected by depressive symptoms, anxiety, energy and fatigue level, sleep, and pain; Nursing home and acute-care hospitalization length of stay; Cost-effectiveness

Estimated Enrollment: 424
Study Start Date: April 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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 factor in an older person's ability to function independently is mobility, the ability to move without assistance. Older people who lose mobility are less likely to remain in the community, have higher rates of morbidity, mortality, and hospitalizations and experience a poorer quality of life. While several studies suggest that physical activity may prevent physical disability, including mobility disability in both healthy and frail older adults, definitive evidence is lacking. A Phase 3, randomized, controlled trial is needed to fill this evidence gap. Currently data to estimate sample size needs for such a trial are insufficient and further feasibility data should be gathered before such a trial can be effectively designed and implemented.

To refine key trial design benchmarks (including sample size calculations to demonstrate the feasibility of a full-scale trial and refining/developing recruitment, procedures, materials and organizational infrastructure), the LIFE (Lifestyle Interventions for Independence in Elders) study conducts a pilot, single-blind, randomized, controlled trial involving comparison of a physical activity program of moderate intensity to a successful aging program. Approximately 400 sedentary persons aged 70 to <90 years who are at risk of disability are followed for at least one year at four intervention sites: Wake Forest University School of Medicine in Winston Salem, NC; the University of Pittsburgh in Pittsburgh, PA; the Cooper Institute in Dallas, TX; and the Stanford University in Palo Alto, CA. The Administrative Coordinating Center and the Data Management and Quality Control Center are at Wake Forest University School of Medicine.

The LIFE study assesses the combined outcome of major mobility disability, defined as the incapacity to walk 400 meters (m), or death, which will be the primary outcome of the full-scale study. This outcome has not been used in previous randomized, controlled trials, and therefore, a pilot study is needed to assess its incidence rate. Secondary outcomes include ADL disability, major fall injuries and cardiovascular events. LIFE explores the effects of the intervention on physical performance measures, cognitive function, health-related quality of life, and use of health care services. In addition, LIFE explores and performs cost-effectiveness analyses of the intervention.

This pilot study will yield the necessary preliminary data to design a definitive Phase 3, randomized, controlled trial. By providing a conclusive answer regarding whether physical activity is effective for preventing major mobility disability or death, the results of the full-scale trial will have relevant clinical and public health implications, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine.

  Eligibility

Ages Eligible for Study:   70 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116194

Locations
United States, California
Stanford University
Palo Alto, California, United States, 27157
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Cooper Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Investigators
Principal Investigator: Marco Pahor, MD Professor and Chair, Department of Aging and Geriatric Research, College of Medicine, Director Institute on Aging, University of Florida
Principal Investigator: Jack Guralnik, MD, PhD Acting Chief, Laboratory of Epidemiology, Demography and Biometry, National Institute on Aging
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00116194     History of Changes
Other Study ID Numbers: AG0021, U01AG022376
Study First Received: June 27, 2005
Last Updated: March 24, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
exercise
activities of daily living
ADL
loss of mobility
risk of disability
physical activity
mobility disability

ClinicalTrials.gov processed this record on September 16, 2014