The lifestyle interventions and independence for elders study: design and methods

Authors: FIELDING, ROGER A. - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; REJESKI, W. JACK - Wake Forest University; BLAIR, STEPHEN - University Of South Carolina; CHURCH, TIM - Pennington Biomedical Research Center; ESPELAND, MARK A. - Wake Forest University; GILL, THOMAS M. - Yale University; GURALNIK, JACK M. - University Of Maryland; HSU, FANG-CHI - Yale University; KATULA, JEFFERY - Wake Forest University; KING, ABBY C. - Stanford University School Of Medicine; KRITCHEVSKY, STEPHEN B. - Wake Forest University; MCDERMOTT, MARY M. - Northwestern University; MILLER, MICHAEL E. - Wake Forest University; NAYFIELD, SUSAN - University Of Florida; NEWMAN, ANNE B. - University Of Pittsburgh Medical Center; WILLIAMSON, JEFF D. - Wake Forest University; BONDS, DENISE - National Heart, Lung And Blood Institute(NHLBI, NIH); ROMASHKAN, SERGEI - National Institute On Aging (NIA, NIH); HADLEY, EVAN - National Institute On Aging (NIA, NIH); PAHOR, MARCO - University Of Florida

Submitted to: Journal of Gerontology Biological Science
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/19/2011
Publication Date: 8/8/2011
Citation: Fielding, R., Rejeski, W., Blair, S., Church, T., Espeland, M., Gill, T., Guralnik, J., Hsu, F., Katula, J., King, A., Kritchevsky, S., Mcdermott, M., Miller, M., Nayfield, S., Newman, A., Williamson, J., Bonds, D., Romashkan, S., Hadley, E., Pahor, M. 2011. The lifestyle interventions and independence for elders study: design and methods. Journal of Gerontology Biological Science. DOI: 10.1093/gerona/girl123.

Interpretive Summary: 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. 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. 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. Results of this study are expected to have important public health implications for the large and growing population of older sedentary men and women.

Technical 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.