title: The Lifestyle Interventions and Independence for Elders Study: design and methods.
abstract: BACKGROUND
  As the number of older adults in the United States rises, maintaining functional independence among older Americans has emerged as a major clinical and public health priority. Older people who lose mobility are less likely to remain in the community; demonstrate higher rates of morbidity, mortality, and hospitalizations; and experience a poorer quality of life. Several studies have shown that regular physical activity improves functional limitations and intermediate functional outcomes, but definitive evidence showing that major mobility disability can be prevented is lacking. A Phase 3 randomized controlled trial is needed to fill this evidence gap.
  
  
  METHODS
  The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled trial designed to compare a supervised moderate-intensity physical activity program with a successful aging health education program in 1,600 sedentary older persons followed for an average of 2.7 years.
  
  
  RESULTS
  LIFE's primary outcome is major mobility disability, defined as the inability to walk 400 m. Secondary outcomes include cognitive function, serious fall injuries, persistent mobility disability, the combined outcome of major mobility disability or death, disability in activities of daily living, and cost-effectiveness.
  
  
  CONCLUSIONS
  Results of this study are expected to have important public health implications for the large and growing population of older sedentary men and women.
authors.affiliation: Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA 02111, USA. roger.fielding@tufts.edu
authors.forename: Roger A
authors.initials: RA
authors.lastname: Fielding
authors.forename: W Jack
authors.initials: WJ
authors.lastname: Rejeski
authors.forename: Steven
authors.initials: S
authors.lastname: Blair
authors.forename: Tim
authors.initials: T
authors.lastname: Church
authors.forename: Mark A
authors.initials: MA
authors.lastname: Espeland
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Gill
authors.forename: Jack M
authors.initials: JM
authors.lastname: Guralnik
authors.forename: Fang-Chi
authors.initials: FC
authors.lastname: Hsu
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Katula
authors.forename: Abby C
authors.initials: AC
authors.lastname: King
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Kritchevsky
authors.forename: Mary M
authors.initials: MM
authors.lastname: McDermott
authors.forename: Michael E
authors.initials: ME
authors.lastname: Miller
authors.forename: Susan
authors.initials: S
authors.lastname: Nayfield
authors.forename: Anne B
authors.initials: AB
authors.lastname: Newman
authors.forename: Jeff D
authors.initials: JD
authors.lastname: Williamson
authors.forename: Denise
authors.initials: D
authors.lastname: Bonds
authors.forename: Sergei
authors.initials: S
authors.lastname: Romashkan
authors.forename: Evan
authors.initials: E
authors.lastname: Hadley
authors.forename: Marco
authors.initials: M
authors.lastname: Pahor
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D015577:Geriatric Assessment; D006266:Health Education; D006305:Health Status Indicators; D006801:Humans; D057194:Intention to Treat Analysis; D008019:Life Style; D008297:Male; D017063:Outcome Assessment, Health Care; D012107:Research Design; D057185:Sedentary Behavior; D016138:Walking