The LIFE Study: Lifestyle Interventions and Independence for Elders, Pilot
Condition: Physically Challenged; Aging
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: exercise; activities of daily living; ADL; loss of mobility; risk of disability; physical activity; mobility disability