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OBJECTIVES: To investigate exercise effects on falls in people with dementia living in nursing homes, and whether effects were dependent on sex, dementia type, or improvement in balance. A further aim was to describe the occurrence of fall-related injuries.

DESIGN: A cluster-randomized controlled trial.

SETTING AND PARTICIPANTS: The Umeå Dementia and Exercise study was set in 16 nursing homes in Umeå, Sweden and included 141 women and 45 men, a mean age of 85 years, and with a mean Mini-Mental State Examination score of 15.

INTERVENTION: Participants were randomized to the high-intensity functional exercise program or a seated attention control activity; each conducted 2-3 times per week for 4 months.

MEASURES: Falls and fall-related injuries were followed for 12 months (after intervention completion) by blinded review of medical records. Injuries were classified according to severity.

RESULTS: During follow-up, 118(67%) of the participants fell 473 times in total. At the interim 6-month follow-up, the incidence rate was 2.7 and 2.8 falls per person-year in exercise and control group, respectively, and at 12-month follow-up 3.0 and 3.2 falls per person-year, respectively. Negative binomial regression analyses indicated no difference in fall rate between groups at 6 or 12 months (incidence rate ratio 0.9, 95% confidence interval (CI) 0.5-1.7, P = .838 and incidence rate ratio 0.9, 95% CI 0.5-1.6, P = .782, respectively). No differences in exercise effects were found according to sex, dementia type, or improvement in balance. Participants in the exercise group were less likely to sustain moderate/serious fall-related injuries at 12-month follow-up (odds ratio 0.31, 95% CI 0.10-0.94, P = .039).

CONCLUSIONS/IMPLICATIONS: In older people with dementia living in nursing homes, a high-intensity functional exercise program alone did not prevent falls when compared with an attention control group. In high-risk populations, in which multimorbidity and polypharmacy are common, a multifactorial fall-prevention approach may be required. Encouraging effects on fall-related injuries were observed, which merits future investigations.