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A Preplanned Meta-analysis of the FICSIT Trials

Michael A. Province, PhD; Evan C. Hadley, MD; Mark C. Hornbrook, PhD; Lewis A. Lipsitz, MD; J. Philip Miller; Cynthia D. Mulrow, MD; Marcia G. Ory, PhD, MPH; Richard W. Sattin, MD; Mary E. Tinetti, MD; Steven L. Wolf, PhD; the FICSIT Group; J. Philip Miller; Michael A. Province, PhD; Kenneth B. Schechtman, PhD; Cynthia L. Arfken, PhD; Jane Rossiter-Fornoff, DPhil.; Mark C. Hornbrook, PhD; Victor J. Stevens, PhD; Darlene J. Wingfield, MPA, PT; Merwyn R. Greenlick, PhD; Mary E. Tinetti, MD; Dorothy I. Baker, PhD, RNC; Elizabeth B. Claus, PhD; Ralph I. Horwitz, MD.; David M. Buchner, MD, MPH; Edward H. Wagner, MD, MPH; Barbara J. de Lateur, MD; M. Elaine Cress, PhD; Robert Price, MMSE; Itamar B. Abrass, MD; Peter Esselman, MD; Tony Marguerita, MD.; Cynthia D .; Mulrow, MD; Meghan B. Gerety, MD; John E. Cornell, PhD; Louis A. DeNino, PhD; Deanna Kanten; Steven L. Wolf, PhD; Nancy G. Kutner, PhD; Robert C. Green, MD; Elizabeth McNeely, PhD; Carol Coogler, PT, DSc.; Maria A. Fiatarone, MD; Evelyn F. O'Neill, CTRS; Nancy Doyle Ryan; Diet T; Karen M. Clements, MPH; Lewis A. Lipsitz, MD; Joseph J. Kehayias, PhD; Susan B. Roberts, PhD; William J. Evans, PhD.; Robert Wallace, MD; Jo Ellen Ross, MA; Jeffrey C. Huston, PhD; Carolyn J. Kundel, PhD; Michael S. Sellberg, BS.; Leslie I. Wolfson, MD; Robert H. Whipple, MA; Paula M. Amerman, RN, MSN; James O. Judge, MD; Carol A. Derby, PhD; Mary B. King, MD.; Evan C. Hadley, MD; Ashlesha Tamboli, MD, PhD; Marcia G. Ory, PhD, MPH; Sharlene Weiss, PhD, RN; Richard W. Sattin, MD

JAMA. 1995;273(17):1341-1347.

Abstract
Objective.
—To determine if short-term exercise reduces falls and fall-related injuries in the elderly.

Design.
—A preplanned meta-analysis of the seven Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT)—independent, randomized, controlled clinical trials that assessed intervention efficacy in reducing falls and frailty in elderly patients. All included an exercise component for 10 to 36 weeks. Fall and injury follow-up was obtained for up to 2 to 4 years.

Setting.
—Two nursing home and five community-dwelling (three health maintenance organizations) sites. Six were group and center based; one was conducted at home.

Participants.
—Numbers of participants ranged from 100 to 1323 per study. Subjects were mostly ambulatory and cognitively intact, with minimum ages of 60 to 75 years, although some studies required additional deficits, such as functionally dependent in two or more activities of daily living, balance deficits or lower extremity weakness, or high risk of falling.

Interventions.
—Exercise components varied across studies in character, duration, frequency, and intensity. Training was performed in one area or more of endurance, flexibility, balance platform, Tai Chi (dynamic balance), and resistance. Several treatment arms included additional nonexercise components, such as behavioral components, medication changes, education, functional activity, or nutritional supplements.

Main Outcome Measures.
—Time to each fall (fall-related injury) by self-report and/or medical records.

Results.
—Using the Andersen-Gill extension of the Cox model that allows multiple fall outcomes per patient, the adjusted fall incidence ratio for treatment arms including general exercise was 0.90 (95% confidence limits [CL], 0.81, 0.99) and for those including balance was 0.83 (95% CL, 0.70,0.98). No exercise component was significant for injurious falls, but power was low to detect this outcome.

Conclusions.
—Treatments including exercise for elderly adults reduce the risk of falls.

(JAMA. 1995;273:1341-1347)

Author Affiliations
Division of Biostatistics, Washington University School of Medicine, St Louis, Mo (research grant U01 AG09098):; Center for Health Research, Kaiser Permanente, NW Region, Portland, Ore (research grant U01 AG09089):; Program on Aging, Yale University School of Medicine, New Haven, Conn (research grant U01 AG09087):; Department of Health Sciences, University of Washington, Seattle (research grant U01 AG09095):; Geriatric Research, Education, and Clinical Center, Audie L. Murphy Veterans Hospital, San Antonio, Tex (research grant U01 AG09117):; Emory University School of Medicine, Department of Rehabilitation Medicine, Atlanta, Ga (research grant U01 AG09124):; Hebrew Rehabilitation Center for Aged, Harvard Medical School and USDA Human Nutrition Research Center on Aging, Boston, Mass (research; grant U01 AG09078):; University of Iowa, Iowa City, Iowa State University, Ames (research grant U01 AG09123):; Department of Neurology, University of Connecticut Health Cen-; ter, Farmington (research grant U01 AG09096):; National Institute on Aging and National Institute for Nursing Research, Bethesda, Md:; Centers for Disease Control and Prevention, Atlanta, Ga:

From the Division of Biostatistics, Washington University School of Medicine, St Louis, Mo (Dr Province and Mr Miller); National Institute on Aging, National Institutes of Health, Bethesda, Md (Drs Hadley and Ory); Center for Health Research, Kaiser Permanente, Northwest Region, Portland, Ore (Dr Hornbrook); Hebrew Rehabilitation Center for Aged, Beth Israel Hospital, Harvard Medical School, Boston, Mass (Dr Lipsitz); Department of Medicine, Ambulatory Care, Audie L. Murphy Veterans Hospital, San Antonio, Tex (Dr Mulrow); Centers for Disease Control and Prevention, Atlanta, Ga (Dr Sattin); Program on Aging, Yale University School of Medicine, New Haven, Conn (Dr Tinetti); and Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, Ga (Dr Wolf).

Footnotes
A complete list of the FICSIT Group appears at the end of this article.

Reprint requests to Division of Biostatistics, Washington University School of Medicine, Box 8067, 600 S Euclid St, St Louis, MO 63110 (Dr Province).

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