As life expectancy in the US continues to rise, the maintenance of independence among older Americans has emerged as a major clinical and public health priority. Efficient and reliable locomotion, or the ability to move without assistance, is a fundamental feature of human functioning. 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. Several studies have shown that regular physical activity improves physical performance, but definitive evidence showing that mobility disability can be prevented is lacking. A Phase 3 randomized, controlled trial is needed to fill this evidence gap. This application is a competitive renewal for the """"""""Physical Exercise to Prevent Disability"""""""" pilot study, lay title """"""""Lifestyle Interventions and Independence For Elders - LIFE"""""""" pilot study. The Data Safety Monitoring Board unanimously """"""""determined that all pilot study benchmarks, including infrastructure, quality control, recruitment, adherence with the interventions, retention, safety, outcomes rates, outcomes definition refinement, and sample size estimates, were successfully achieved."""""""" We propose conducting a Phase 3, single-masked multicenter randomized controlled trial to compare a moderate-intensity physical activity program to a successful aging health education program in sedentary older persons who are at risk of disability. This trial will enable us to address the aims listed below. The primary aim is to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, as operationalized by the inability to walk 400 m. Secondary aims focus on assessing the relative effects of the interventions on the following secondary outcomes: 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. 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 ethnicity/race, gender and baseline physical performance;and (c) to explore time by intervention interactions on the SPPB score and 400 m walk speed endpoints. The proposed trial will provide definitive evidence regarding whether physical activity is effective and practical for preventing major mobility disability.

Public Health Relevance

Should LIFE-M be successful, it would modify the current guidelines by providing a new indication for the physical activity intervention used in LIFE: the prevention or delay of major mobility disability. These results will have crucial implications for public health prevention in a rapidly aging society, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine. The study will also yield valuable information concerning the efficacy and effectiveness of physical activity on a broad spectrum of other important health outcome, and will impact both clinical practice and public health policy, and will, therefore, benefit individuals and society.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZAG1)
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Romashkan, Sergei
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University of Florida
Internal Medicine/Medicine
Schools of Medicine
United States
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Santanasto, Adam J; Glynn, Nancy W; Lovato, Laura C et al. (2017) Effect of Physical Activity versus Health Education on Physical Function, Grip Strength and Mobility. J Am Geriatr Soc 65:1427-1433
Fielding, Roger A; Guralnik, Jack M; King, Abby C et al. (2017) Dose of physical activity, physical functioning and disability risk in mobility-limited older adults: Results from the LIFE study randomized trial. PLoS One 12:e0182155
Kritchevsky, Stephen B; Lovato, Laura; Handing, Elizabeth P et al. (2017) Exercise's effect on mobility disability in older adults with and without obesity: The LIFE study randomized clinical trial. Obesity (Silver Spring) 25:1199-1205
Chen, Haiying; Ambrosius, Walter T; Murphy, Terrence E et al. (2017) Imputation of Gait Speed for Noncompleters in the 400-Meter Walk: Application to the Lifestyle Interventions for Elders Study. J Am Geriatr Soc 65:2566-2571
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Layne, Andrew S; Hsu, Fang-Chi; Blair, Steven N et al. (2017) Predictors of Change in Physical Function in Older Adults in Response to Long-Term, Structured Physical Activity: The LIFE Study. Arch Phys Med Rehabil 98:11-24.e3
King, Abby C; Salvo, Deborah; Banda, Jorge A et al. (2017) Preserving older adults' routine outdoor activities in contrasting neighborhood environments through a physical activity intervention. Prev Med 96:87-93
Reid, K F; Walkup, M P; Katula, J A et al. (2017) Cognitive Performance Does not Limit Physical Activity Participation in the Lifestyle Interventions and Independence for Elders Pilot Study (LIFE-P). J Prev Alzheimers Dis 4:44-50
Manini, Todd M; Beavers, Daniel P; Pahor, Marco et al. (2017) Effect of Physical Activity on Self-Reported Disability in Older Adults: Results from the LIFE Study. J Am Geriatr Soc 65:980-988
Aubertin-Leheudre, Mylène; Anton, Stephen; Beavers, Daniel P et al. (2017) Dynapenia and Metabolic Health in Obese and Nonobese Adults Aged 70 Years and Older: The LIFE Study. J Am Med Dir Assoc 18:312-319

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