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Long-term outcomes of exercise: follow-up of a randomized trial in older women with osteopenia
Korpelainen R, Keinanen-Kiukaanniemi S, Nieminen P, Heikkinen J, Vaananen K, Korpelainen J
Archives of Internal Medicine 2010 Sep 27;170(17):1548-1556
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Long-term evidence from randomized trials of the effectiveness of exercise in preventing disability and fall-related fractures in elderly people has been lacking. METHODS: We performed extended follow-up of 160 women (aged 70 to 73 years at baseline) with osteopenia in a population-based, randomized, controlled exercise trial. The trial was conducted from April 1 through April 30, 2001. Follow-up was conducted from May 1, 2001, through December 31, 2005. Mean total time in observation was 7.1 years. Primary outcome measures were femoral neck bone mineral density, postural sway, and leg strength. Secondary outcome measures were hospital-treated fractures and functional ability measures. Outcomes were measured annually using masked assessors. RESULTS: There was a significant difference between groups in favor of exercise in terms of postural sway (group x time interaction, p = 0.005), walking speed (group x time interaction, p < 0.001), and Frenchay Activities Index score (group x time interaction, p = 0.001). The bone mineral density decreased similarly across time in both groups. The incidence rate of fractures during the total follow-up among women in the exercise group versus women in the control group was 0.05 versus 0.08 per 1,000 person-years (Poisson incidence rate ratio 0.68; 95% confidence interval, 0.34 to 1.32). There were no hip fractures in the exercise group, whereas 5 hip fractures occurred in the control group. One woman in the exercise group and 8 women in the control group died (Poisson incidence rate ratio 0.11; 95% confidence interval 0.01 to 0.85). CONCLUSION: Mainly home-based exercises followed by voluntary home training seem to have a long-term effect on balance and gait and may even protect high-risk elderly women from hip fractures. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00655577.

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