Aging Clinical Trial
Official title:
Physical Exercise to Prevent Disability Pilot Study
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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