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| Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study |
| Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA |
| Archives of Internal Medicine 2010 Jan 25;170(2):179-185 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; 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* |
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BACKGROUND: Physical exercise affects many risk factors and diseases and therefore can play a vital role in general disease prevention and treatment of elderly individuals and may reduce costs. We sought to determine whether a single exercise program affects fracture risk (bone mineral density (BMD) and falls), coronary heart disease (CHD) risk factors, and health care costs in community-dwelling elderly women. METHODS: We conducted a randomized, single-blinded, controlled trial from May 1, 2005, through July 31, 2008, recruiting women 65 years or older who were living independently in the area of Erlangen-Nuremberg, Germany. In all, 246 women were randomly assigned to an 18-month exercise program (exercise group) or a wellness program (control group). The exercise group (n = 123) performed a multipurpose exercise program with special emphasis on exercise intensity; the controls (n = 123) focused on well-being with a low-intensity, low-frequency program. The main outcome measures were BMD, the number of falls, the Framingham-based 10-year CHD risk, and direct health care costs. RESULTS: For the 227 women who completed the 18-month study, significant exercise effects were observed for BMD of the lumbar spine (mean (95% confidence interval (CI)) percentage of change in BMD (baseline to follow-up) for the exercise group: 1.77% (1.26% to 2.28%) versus controls: 0.33% (-0.24% to 0.91%); p < 0.001), femoral neck (exercise group: 1.01% (0.37% to 1.65%) versus controls: -1.05% (-1.70% to -0.40%); p < 0.001), and fall rate per person during 18 months (exercise group: 1.00 (0.76 to 1.24) versus controls: 1.66 (1.33 to 1.99); p = 0.002). The 10-year CHD risk was significantly affected in both subgroups (absolute change for the exercise group: -1.96% (95% CI, -2.69% to -1.23%) versus controls: -1.15% (-1.69% to -0.62%); p = 0.22), with no significant difference between the groups. The direct health care costs per participant during the 18-month intervention showed nonsignificant differences between the groups (exercise group: Euro 2,255 (95% CI 1,791 to 2,718) versus controls: Euro 2,780 (2,187 to 3,372); p = 0.20). CONCLUSION: Compared with a general wellness program, our 18-month exercise program significantly improved BMD and fall risk, but not predicted CHD risk, in elderly women. This benefit occurred at no increase in direct costs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00267839.
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