Lifestyle Interventions and Independence for Elders (LIFE) Study
(A Phase 3 randomized controlled trial of lifestyle interventions to preserve ability to walk in older adults)

Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years.

The primary aim is to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m.

Secondary aims focus on assessing the relative effects of the interventions on the following outcomes: cognitive function; serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; cardiovascular and pulmonary events; and cost-effectiveness.

Tertiary aims relate to assessing the relative effects of the interventions on (a) the combined outcome of mild cognitive impairment or dementia and (b) physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance.

The proposed trial will provide definitive evidence regarding whether lifestyle modification interventions are effective and practical for preventing major mobility disability. Eight sites around the country participate in the LIFE study.