BACKGROUND: Few studies examined interventions in frail elderly in China, while the awareness of applying interventions to prevent frailty in pre-frail elderly is still lacking. This study aimed to explore the effects of lower limb resistance exercise in pre-frail elderly in China. METHODS: This was a randomized controlled trial of patients with pre-frailty. The control group received routine care, while the exercise group received a 12-week lower limb resistance exercise based on routine care. The muscle strength in the lower limbs, physical fitness, and energy metabolism of the patients was evaluated at admission and after 12 weeks of intervention. RESULTS: A total of 60 pre-frail elderly were included in this study. The patients were divided into the exercise group (n = 30) and control group (n = 30) by random grouping. There were 17 men and 13 women aged 65.3 +/- 13.4 in the exercise group, and 15 men and 15 women aged 67.6 +/- 11.9 years in the control groups. The Barthel Index was 80.3 +/- 10.6 and 85.1 +/- 11.6, respectively. The characteristics of the two groups were not significantly different before intervention (all p > 0.05). The results of repeated measurement ANOVA showed that there was statistically significant in crossover effect of group x time (all p < 0.05), that is, the differences of quadriceps femoris muscle strength, 6-min walking test, 30-s sit-to-stand test, 8-ft "Up and Go" test, daily activity energy expenditure and metabolic equivalent between the intervention group and the control group changed with time, and the variation ranges were different. The main effects of time were statistically significant (all p < 0.05), namely, femoris muscle strength, 6-min walking test, 30-s sit-to-stand test, 8-ft "Up and Go" test, daily activity energy expenditure and metabolic equivalent of the intervention group and the control group were significantly different before and after intervention. The main effects of groups were statistically significant (p < 0.05), namely, femoris muscle strength, 6-min walking test, 30-s sit-to-stand test, daily activity energy expenditure and metabolic equivalent before and after intervention were significantly different between the intervention group and the control group, while there was no significant differences in 8-ft "Up and Go" test between groups. CONCLUSION: Lower limb resistance exercise used for the frailty intervention could improve muscle strength, physical fitness, and metabolism in pre-frail elderly. TRIAL REGISTRATION: ChiCTR, ChiCTR2000031099. Registered 22 March 2020, http://www.chictr.org.cn/edit.aspx?pid=51221&htm=4.

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