Recovery Act Funds Support Large-Scale Clinical Trial to Test Specific Exercise Program.
The funding will begin the Lifestyle Interventions and Independence for Elders "LIFE "trial, the largest ever undertaken to prevent mobility disability among older people who are at risk of losing their ability to walk and to live independently in the community. The grant is being awarded to the University of Florida's Institute on Aging in Gainesville.
The first two years of the six-year, eight-site LIFE trial are being funded through the American Recovery and Reinvestment Act. The grants are part of the $5 billion that President Obama announced Sept. 30 on the NIH campus.
"There is a lot of evidence indicating that exercise can help in preventing diseases, such as diabetes, among older people. But we do not know whether and how a specific regimen might prevent walking disability in older people who are at risk of losing mobility," said NIA Director Richard J. Hodes, M.D. "This research is critically important at a time when the population is aging and new interventions should be sought to keep people healthy and functioning in the community longer."
At eight sites around the country, LIFE will involve 1,600 people aged 70 to 89, who at the start of the study meet its criteria for risk of walking disability, defined as the inability to walk a quarter of a mile or four blocks. About 200 participants will be enrolled at each of the study sites, which include the University of Florida; the University of Pittsburgh; Northwestern University School of Medicine in Chicago; Stanford University in Palo Alto, Calif.; Pennington Biomedical Research Center in Baton Rouge, La.; Yale University in New Haven, Conn.; Tufts University in Boston and Wake Forest University School of Medicine in Winston-Salem, N.C. Wake Forest will also coordinate the data management and analysis.
"Limitations in walking ability compromise independence and contribute to the need for assistive care," said Evan C. Hadley, M.D., director of NIA's Division of Geriatrics and Clinical Gerontology, whose program is overseeing the trial. "Older people with impaired walking are less likely to remain in the community, have higher rates of certain diseases and death, and experience a poorer quality of life. A successful intervention might help prevent these bad outcomes."
"We know that many older people have chronic health problems that affect their ability to walk," said Jack Guralnik, M.D., Ph.D., chief of the NIA's Laboratory of Epidemiology, Demography and Biometry and co-principal investigator of the study. "Arthritis, muscle weakness and poor balance can all affect how well and how far a person can walk. And, some older people have all of these problems. We will test the LIFE intervention in this population to see how it works in a real-world setting."
Study participants will be randomly assigned to one of two groups. One group will follow a structured intervention consisting of walking at moderate intensity, stretching, balance and lower extremity strength training; the control group will participate in a health education program. The participants will be followed for about three years. Researchers will evaluate whether, compared to health education, the physical activity intervention reduces the risk of major walking disability, serious fall injuries and disability in activities of daily living, and whether it improves cognitive function. They will also assess the cost-effectiveness of the intervention.
"This will be the largest randomized controlled trial to prevent major mobility disability ever conducted in older persons who are at high risk of losing their physical independence," said Marco Pahor, M.D., director of the University of Florida's Institute on Aging and study principal investigator. "Typically, this population is excluded from large trials, and from this perspective the LIFE study is unique."
The NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people. For more information on research and aging, go to www.nia.nih.gov.
The National Institutes of Health (NIH) "The Nation's Medical Research Agency "includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov
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