The Lifestyle Interventions and Independence for Elders Study: design and methods

Roger A Fielding, W Jack Rejeski, Steven Blair, Tim Church, Mark A Espeland, Thomas M Gill, Jack M Guralnik, Fang-Chi Hsu, Jeffrey Katula, Abby C King, Stephen B Kritchevsky, Mary M McDermott, Michael E Miller, Susan Nayfield, Anne B Newman, Jeff D Williamson, Denise Bonds, Sergei Romashkan, Evan Hadley, Marco Pahor, LIFE Research Group, Mary M McDermott, Bonnie Spring, Joshua Hauser, Martha Gulati, Sanjiv Shah, Kathryn Domanchuk, Rex Graff, Kasia Kadela, Alvito Rego, Timothy Church, Steven Blair, Valerie Myers, Ron Monce, Nathan Britt, Melissa Nauta, Ami Parks, Ruben Rodarte, Heidi Millet, Catrine Tudor-Locke, Ben Butitta, Sheletta Donatto, Evan C Hadley, Kushang V Patel, Sergei Romashkan, Robert M Kaplan, Abby C King, Cynthia M Castro, William L Haskell, Randall S Stafford, Veronica Yank, Leslie A Pruitt, Kathy Berra, Carol Bell, Rosita Thiessen, Kate P Youngman, Selene B Virgen, Kristina N Tarin, Heather Klaftenegger, Carolyn A Prosak, Ines Campero, Dulce M Garcia, José Soto, Linda Chio, David Hoskins, Roger Fielding, Miriam Nelson, Sara Folta, Edward Phillips, Christine Liu, Erica Cifarelli, Kieran Reid, Paige Lacasse, Dylan Kirn, Evan Pasha, Sonnly Ribourg, Karen Ruais, Won Kim, Gregory Cloutier, Susan Nayfield, Marco Pahor, Stephen Anton, Thomas Buford, Todd Manini, Joe Nocera, Michael Marsiske, Bhanu Sandesara, Jocelyn Lee, Deborah Hiatt-Jensen, Mieniecia Black, Kimberly Case, Katherine Herring, Amber Schwier-Delvisco, Bill Burk, Brian Hoover, Jeffrey Knaggs, Allison Martin, Chonglun Xie, Holly Morris, Flo Singletary, Jackie Causer, Susan Yonce, Christine Del Boccio, Charles Gay, Tangerica Peavy Alexander, Marco Pahor, Stephen Anton, Thomas Buford, Christiaan Leeuwenburgh, Susan Nayfield, Todd Manini, Connie Caudle, Lauren Crump, Latonia Holmes, Jocelyn Lee, Ronald Lester, Ching-ju Lu, Ryan O'Mara, Carl J Pepine, Mario Ariet, Eileen Handberg, Daniel Deluca, James Hill, Jack M Guralnik, Anne B Newman, Stephanie A Studenski, Bret H Goodpaster, Oscar Lopez, Nancy W Glynn, Janet T Bonk, Jennifer Rush, Piera Kost, Allison Gerger, Pamela Vincent, LaTisha Davis, Mark A Newman, George Grove, Kathy Williams, V A San, San Diego, Erik J Groessl, Stephen B Kritchevsky, Anthony Marsh, Tina Brinkley, Jamehl Demons, Kaycee Sink, Kimberly Kennedy, Rachel Shertzer-Skinner, Abbie Wrights, Rose Fries, Deborah Barr, Jeff Williamson, Kaycee M Sink, Hugh C Hendrie, Stephen R Rapp, Joe Verghese, Nancy Woolard, Michael E Miller, Mark Espeland, Walter Ambrosius, Don Babcock, Daniel Beavers, Robert P Byington, Delilah Cook, Curt Furberg, Candace Goode, Jason Griffin, Lea Harvin, Leora Henkin, John Hepler, Fang-Chi Hsu, Kathy Joyce, Laura Lovato, Wesley Roberson, Julia Robertson, Julia Rushing, Scott Rushing, Cynthia L Stowe, Michael P Walkup, Don Hire, Jack Rejeski, Jeff Katula, Peter H Brubaker, Shannon Mihalko, Janine M Jennings, Kathy Lane, Thomas M Gill, Robert S Axtell, Susan S Kashaf, Nathalie de Renekeire, Joanne M McGloin, Raeleen Mautner, Sharon M Huie-White, Luann Bianco, Janice Zocher, Denise M Shepard, Barbara Fennelly, Sean Halpin, Theresa Barnett, Karen C Wu, Lynne P Iannone, Julie A Bugaj, Christine Bailey, Carlos A Vaz Fragoso, Geoffrey Chupp, Gail Flynn, Thomas M Gill, John Hankinson, Roger A Fielding, W Jack Rejeski, Steven Blair, Tim Church, Mark A Espeland, Thomas M Gill, Jack M Guralnik, Fang-Chi Hsu, Jeffrey Katula, Abby C King, Stephen B Kritchevsky, Mary M McDermott, Michael E Miller, Susan Nayfield, Anne B Newman, Jeff D Williamson, Denise Bonds, Sergei Romashkan, Evan Hadley, Marco Pahor, LIFE Research Group, Mary M McDermott, Bonnie Spring, Joshua Hauser, Martha Gulati, Sanjiv Shah, Kathryn Domanchuk, Rex Graff, Kasia Kadela, Alvito Rego, Timothy Church, Steven Blair, Valerie Myers, Ron Monce, Nathan Britt, Melissa Nauta, Ami Parks, Ruben Rodarte, Heidi Millet, Catrine Tudor-Locke, Ben Butitta, Sheletta Donatto, Evan C Hadley, Kushang V Patel, Sergei Romashkan, Robert M Kaplan, Abby C King, Cynthia M Castro, William L Haskell, Randall S Stafford, Veronica Yank, Leslie A Pruitt, Kathy Berra, Carol Bell, Rosita Thiessen, Kate P Youngman, Selene B Virgen, Kristina N Tarin, Heather Klaftenegger, Carolyn A Prosak, Ines Campero, Dulce M Garcia, José Soto, Linda Chio, David Hoskins, Roger Fielding, Miriam Nelson, Sara Folta, Edward Phillips, Christine Liu, Erica Cifarelli, Kieran Reid, Paige Lacasse, Dylan Kirn, Evan Pasha, Sonnly Ribourg, Karen Ruais, Won Kim, Gregory Cloutier, Susan Nayfield, Marco Pahor, Stephen Anton, Thomas Buford, Todd Manini, Joe Nocera, Michael Marsiske, Bhanu Sandesara, Jocelyn Lee, Deborah Hiatt-Jensen, Mieniecia Black, Kimberly Case, Katherine Herring, Amber Schwier-Delvisco, Bill Burk, Brian Hoover, Jeffrey Knaggs, Allison Martin, Chonglun Xie, Holly Morris, Flo Singletary, Jackie Causer, Susan Yonce, Christine Del Boccio, Charles Gay, Tangerica Peavy Alexander, Marco Pahor, Stephen Anton, Thomas Buford, Christiaan Leeuwenburgh, Susan Nayfield, Todd Manini, Connie Caudle, Lauren Crump, Latonia Holmes, Jocelyn Lee, Ronald Lester, Ching-ju Lu, Ryan O'Mara, Carl J Pepine, Mario Ariet, Eileen Handberg, Daniel Deluca, James Hill, Jack M Guralnik, Anne B Newman, Stephanie A Studenski, Bret H Goodpaster, Oscar Lopez, Nancy W Glynn, Janet T Bonk, Jennifer Rush, Piera Kost, Allison Gerger, Pamela Vincent, LaTisha Davis, Mark A Newman, George Grove, Kathy Williams, V A San, San Diego, Erik J Groessl, Stephen B Kritchevsky, Anthony Marsh, Tina Brinkley, Jamehl Demons, Kaycee Sink, Kimberly Kennedy, Rachel Shertzer-Skinner, Abbie Wrights, Rose Fries, Deborah Barr, Jeff Williamson, Kaycee M Sink, Hugh C Hendrie, Stephen R Rapp, Joe Verghese, Nancy Woolard, Michael E Miller, Mark Espeland, Walter Ambrosius, Don Babcock, Daniel Beavers, Robert P Byington, Delilah Cook, Curt Furberg, Candace Goode, Jason Griffin, Lea Harvin, Leora Henkin, John Hepler, Fang-Chi Hsu, Kathy Joyce, Laura Lovato, Wesley Roberson, Julia Robertson, Julia Rushing, Scott Rushing, Cynthia L Stowe, Michael P Walkup, Don Hire, Jack Rejeski, Jeff Katula, Peter H Brubaker, Shannon Mihalko, Janine M Jennings, Kathy Lane, Thomas M Gill, Robert S Axtell, Susan S Kashaf, Nathalie de Renekeire, Joanne M McGloin, Raeleen Mautner, Sharon M Huie-White, Luann Bianco, Janice Zocher, Denise M Shepard, Barbara Fennelly, Sean Halpin, Theresa Barnett, Karen C Wu, Lynne P Iannone, Julie A Bugaj, Christine Bailey, Carlos A Vaz Fragoso, Geoffrey Chupp, Gail Flynn, Thomas M Gill, John Hankinson

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.

Trial registration: ClinicalTrials.gov NCT01072500.

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