The LIFE Study: Lifestyle Interventions and Independence for Elders, Pilot

NCT00116194 | Completed Phase 1

• 2 other identifiers: AG0021U01AG022376
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to gather preliminary data that will determine the feasibility of conducting a Phase III, randomized, controlled trial (RCT) that will provide definite evidence in the use of physical exercise to prevent mobility disability in older persons.

Conditions

Physically Challenged; Aging

Keywords

exercise; activities of daily living; ADL; loss of mobility; risk of disability; physical activity; mobility disability

Outcome Measures

Primary Outcomes (6)

• Combined outcome of ability to walk 400 m without the use of an assistive device or adjudicated evidence of inability to walk 400 m or death

• Drop-in, drop-out, and loss to follow-up rates

• Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance score

• 4 m gait speed

• 400 m gait speed

• Self-reported disability scale

Secondary Outcomes (5)

• Onset of self- or proxy-reported and objectively assessed disability in activities of daily living (ADLs)

• Serious fall injuries

• Combined cardiovascular events

• Acute care hospitalizations and nursing home admissions

• Cognitive function measures; Health-related quality of life (HRQL), as reflected by depressive symptoms, anxiety, energy and fatigue level, sleep, and pain; Nursing home and acute-care hospitalization length of stay; Cost-effectiveness

Interventions

Physical Activity BEHAVIORAL

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women ages 70 to 89
• Residency in the area for at least 9 months in the next year
• Summary score of under 10 on the Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance battery; ability to complete the 400 m walk test within 15 minutes without sitting and without the use of an assistive device (including a cane) or the help of another person
• Able to understand and perform the required study procedures; no diagnosis of dementia
• Sedentary lifestyle, i.e., has spent less than 20 minutes per week in the past month getting regular physical activity
• Willing to give informed consent, willing to be randomized to either intervention, and to follow the protocol for the group to which they have been assigned
• Successful completion of the behavioral run-in

You may not qualify if:

• Potential difficulty adhering to either intervention
• Unable or unwilling to give informed consent or accept randomization
• Participation may be unsafe
• Serious health conditions that would interfere with the intervention goals
• Already physically active to a degree that the adoption of an activity program would be of little additional benefit
• Self-reported inability to walk two blocks
• Use of walker or assistive device to complete the 400 m walk

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (4)

Stanford University

Palo Alto, California, 27157, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Cooper Institute

Dallas, Texas, 75230, United States

Location

Related Publications (14)

• Rejeski WJ, Fielding RA, Blair SN, Guralnik JM, Gill TM, Hadley EC, King AC, Kritchevsky SB, Miller ME, Newman AB, Pahor M. The lifestyle interventions and independence for elders (LIFE) pilot study: design and methods. Contemp Clin Trials. 2005 Apr;26(2):141-54. doi: 10.1016/j.cct.2004.12.005.

  PMID: 15837437 BACKGROUND

• Guralnik JM, LaCroix AZ, Abbott RD, Berkman LF, Satterfield S, Evans DA, Wallace RB. Maintaining mobility in late life. I. Demographic characteristics and chronic conditions. Am J Epidemiol. 1993 Apr 15;137(8):845-57. doi: 10.1093/oxfordjournals.aje.a116746.

  PMID: 8484376 BACKGROUND

• Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.

  PMID: 8078528 BACKGROUND

• Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31.

  PMID: 8980206 BACKGROUND

• Penninx BW, Messier SP, Rejeski WJ, Williamson JD, DiBari M, Cavazzini C, Applegate WB, Pahor M. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med. 2001 Oct 22;161(19):2309-16. doi: 10.1001/archinte.161.19.2309.

  PMID: 11606146 BACKGROUND

• LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157.

  PMID: 17167156 RESULT

• Ip EH, Chen SH, Rejeski WJ, Bandeen-Roche K, Hayden KM, Hugenschmidt CE, Pierce J, Miller ME, Speiser JL, Kritchevsky SB, Houston DK, Newton RL, Rapp SR, Kitzman DW. Gradient and Acceleration of Decline in Physical and Cognitive Functions in Older Adults: A Disparity Analysis. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1603-1611. doi: 10.1093/gerona/glac109.

  PMID: 35562076 DERIVED

• Fielding RA, Guralnik JM, King AC, Pahor M, McDermott MM, Tudor-Locke C, Manini TM, Glynn NW, Marsh AP, Axtell RS, Hsu FC, Rejeski WJ; LIFE study group. Dose of physical activity, physical functioning and disability risk in mobility-limited older adults: Results from the LIFE study randomized trial. PLoS One. 2017 Aug 18;12(8):e0182155. doi: 10.1371/journal.pone.0182155. eCollection 2017.

  PMID: 28820909 DERIVED

• Newman AB, Dodson JA, Church TS, Buford TW, Fielding RA, Kritchevsky S, Beavers D, Pahor M, Stafford RS, Szady AD, Ambrosius WT, McDermott MM; LIFE Study Group. Cardiovascular Events in a Physical Activity Intervention Compared With a Successful Aging Intervention: The LIFE Study Randomized Trial. JAMA Cardiol. 2016 Aug 1;1(5):568-74. doi: 10.1001/jamacardio.2016.1324.

  PMID: 27439082 DERIVED

• Dotson VM, Hsu FC, Langaee TY, McDonough CW, King AC, Cohen RA, Newman AB, Kritchevsky SB, Myers V, Manini TM, Pahor M; LIFE STUDY GROUP. Genetic Moderators of the Impact of Physical Activity on Depressive Symptoms. J Frailty Aging. 2016;5(1):6-14. doi: 10.14283/jfa.2016.76.

  PMID: 26980363 DERIVED

• O'Hartaigh B, Pahor M, Buford TW, Dodson JA, Forman DE, Gill TM; LIFE Study Group. Physical activity and resting pulse rate in older adults: findings from a randomized controlled trial. Am Heart J. 2014 Oct;168(4):597-604. doi: 10.1016/j.ahj.2014.07.024. Epub 2014 Jul 30.

  PMID: 25262271 DERIVED

• Heffernan KS, Manini TM, Hsu FC, Blair SN, Nicklas BJ, Kritchevsky SB, Newman AB, Sutton-Tyrrell K, Church TS, Haskell WL, Fielding RA. Relation of pulse pressure to long-distance gait speed in community-dwelling older adults: findings from the LIFE-P study. PLoS One. 2012;7(11):e49544. doi: 10.1371/journal.pone.0049544. Epub 2012 Nov 21.

  PMID: 23185357 DERIVED

• Houston DK, Tooze JA, Hausman DB, Johnson MA, Nicklas BJ, Miller ME, Neiberg RH, Marsh AP, Newman AB, Blair SN, Kritchevsky SB. Change in 25-hydroxyvitamin D and physical performance in older adults. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):430-6. doi: 10.1093/gerona/glq235. Epub 2011 Feb 16.

  PMID: 21325343 DERIVED

• Hsu FC, Rejeski WJ, Ip EH, Katula JA, Fielding R, Jette AM, Studenski SA, Blair SN, Miller ME. Evaluation of the late life disability instrument in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) study. Health Qual Life Outcomes. 2010 Oct 6;8:115. doi: 10.1186/1477-7525-8-115.

  PMID: 20925931 DERIVED

Related Links

• The LIFE Study

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marco Pahor, MD

  Professor and Chair, Department of Aging and Geriatric Research, College of Medicine, Director Institute on Aging, University of Florida

  PRINCIPAL INVESTIGATOR

• Jack Guralnik, MD, PhD

  Acting Chief, Laboratory of Epidemiology, Demography and Biometry, National Institute on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 27, 2005
• First Posted: June 28, 2005
• Study Start: April 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: March 25, 2010

Record last verified: 2008-12

Locations

US (4)