K. Nakamura, K. Kurosaki, Masakazu Imaoka, M. Ikeuchi, Tetsuya Ueda, M. Yasuoka, A. Masue, Tomomi Kitagawa, Emiko Todo, Yumi Higuchi, T. Mizuno, K. Hirasima, Suguru Ando, and D. Shichikawa
Background: It has been previously shown that the intake of natural vitamin D compounds helps prevent falls among facility residents, whereas a multifactorial intervention does not necessarily prevent falls. Furthermore, exercise alone reportedly increases falls among the institutionalized frail elderly. Purpose: This study aimed to compare the reduction in falls among institutionalized frail elderly between interventions using exercise reduction, vitamin D supplementation, or a combination of both. Methods: The participants were residents in a longterm care health facility in Osaka, Japan. A randomized, non-blinded, controlled clinical trial was conducted from September 2013 to June 2014. The participants (n= 91) were divided into four groups based on the intervention. The participants were randomized to the four groups: control group, reduced exercise group, nutrition group, andmultifactorial group. The control group (n= 23) was provided usual care. Usual care included advice on environmental adaptations, falls prevention education, care conference, select walking aids, two sessions of individualized exercise for 20minutes per week, and resistance exercise for 30minutes per week. The reduced exercise group (n= 22) did not perform resistance exercise. The nutrition group (n= 23) was administered oral vitamin D (900 IU/day). The multifactorial group (n= 23) performed reduced levels of exercise and received vitamin D supplementation. The intervention period lasted three months, and falls were recorded for a 6-month follow-up period. The baseline data included age, sex, BMI, FIM, 25 hydroxyvitamin D, skeletal muscle mass index, grip strength, history of falls, and cognitive function. Falls were defined using the International Classification of Diseases. The primary endpoint was the incidence of falls, which was analyzed using Cox proportional-hazards regression analysis. The falls data were compared between the four groups. A two-way analysis of variance was used to compare preand post-test measurements and determine if there was an intervention effect. Results: Sixteen of the participants did not complete the study (retention rate, 82.4%). During the follow-up period, falls occurred in nine participants (52.9%) in the control group, seven participants (31.8%) in the reduced exercise group, six participants (35.3%) in the nutrition group, and four participants (21.1%) in the multifactorial group. In the two-way analysis of variance, group-time interactions indicated clear improvements in 25 (OH) D. However, the other outcome measures were not significantly different among the 4 groups. The Cox proportional-hazard regression analysis, adjusted for sex and age, resulted in the following hazard ratios, compared with the control group: reduced exercise group, hazard ratio 0.48, 95% confidence interval (CI) 0.17–1.30; nutrition group, hazard ratio 0.58, 95% CI 0.20–1.68; and multifactorial group, hazard ratio 0.28, 95% CI0.08–0.92. The valueswere significantly different between the control and multifactorial groups. Conclusion(s): The results suggest that the multifactorial intervention of reduced exercise and vitamin D supplementation is effective for falls reduction in institutionalized frail elderly. Implications: To prevent falls in facility residents, both physical abilities and nutritional status should be considered.