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

Aging Clinical Trial

Official title:

Physical Exercise to Prevent Disability Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116194
• Other study ID #: AG0021
• Secondary ID: U01AG022376
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 27, 2005
• Last updated: March 24, 2010
• Start date: April 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 of physical exercise to prevent mobility disability in older persons.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging
• Physically Challenged

Intervention

Behavioral:
• Physical Activity

Locations

Country	Name	City	State
United States	Cooper Institute	Dallas	Texas
United States	Stanford University	Palo Alto	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31. — View Citation

Guralnik JM, LaCroix AZ, Abbott RD, Berkman LF, Satterfield S, Evans DA, Wallace RB. Maintaining mobility in late life. I. Demographic characteristics and chronic conditions. Am J Epidemiol. 1993 Apr 15;137(8):845-57. — View Citation

LIFE Study Investigators, Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures o — View Citation

Penninx BW, Messier SP, Rejeski WJ, Williamson JD, DiBari M, Cavazzini C, Applegate WB, Pahor M. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med. 2001 Oct 22;161(19):2309-16. — View Citation

Rejeski WJ, Fielding RA, Blair SN, Guralnik JM, Gill TM, Hadley EC, King AC, Kritchevsky SB, Miller ME, Newman AB, Pahor M. The lifestyle interventions and independence for elders (LIFE) pilot study: design and methods. Contemp Clin Trials. 2005 Apr;26(2):141-54. — View Citation

Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Drop-in, drop-out, and loss to follow-up rates
Primary	Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance score
Primary	4 m gait speed
Primary	400 m gait speed
Primary	Self-reported disability scale
Secondary	Onset of self- or proxy-reported and objectively assessed disability in activities of daily living (ADLs)
Secondary	Serious fall injuries
Secondary	Combined cardiovascular events
Secondary	Acute care hospitalizations and nursing home admissions
Secondary	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

External Links

•   The LIFE Study