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      The osteoporotic fracture prevention program in rural areas (OFRA): a protocol for a cluster-randomized health care fund driven intervention in a routine health care setting

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          Abstract

          Background

          Fragility fractures are one of the leading causes for disability in old people. The main underlying mechanisms are osteoporosis and falls. Evidence-based measures to prevent either falls or fractures are available. However, coordinated preventive approaches combining bone health and fall prevention are rare.

          The objective of the study is to evaluate a health care fund driven program, which encourages insured persons to adhere to national guidelines regarding bone health and physical activity and falls prevention. The health care fund cooperates with the ‘German Association of Rural Women’ and the ‘German Gymnastics Association’. The program consists of mobility and falls prevention classes, the examination of bone health by a DXA scan, and a consultation about ‘safety in the living environment’.

          Methods

          Cluster-randomized study in 47 intervention and 143 control districts in 5 federal states of Germany. The program is offered to a) community-living women and men aged 70 to <85 years with a prior fragility fracture or b) community-living women aged 75 to <80 years. Within two years more than 10,000 persons will be directly contacted and motivated to make use of the components of the program. The primary outcome is a combined measure of incident osteoporotic fractures. Secondary outcomes include the rate of referrals to a mobility and falls prevention class or a bone mass density measurement. An economic evaluation will be conducted.

          Discussion

          The study evaluates a complex preventive intervention in a routine health care setting which may serve as model for similar approaches in other areas or countries.

          Trial registration

          DRKS-ID: DRKS00009000; date of registration: 06.08.2015

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          Most cited references15

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          Capture the Fracture: a Best Practice Framework and global campaign to break the fragility fracture cycle

          Summary The International Osteoporosis Foundation (IOF) Capture the Fracture Campaign aims to support implementation of Fracture Liaison Services (FLS) throughout the world. Introduction FLS have been shown to close the ubiquitous secondary fracture prevention care gap, ensuring that fragility fracture sufferers receive appropriate assessment and intervention to reduce future fracture risk. Methods Capture the Fracture has developed internationally endorsed standards for best practice, will facilitate change at the national level to drive adoption of FLS and increase awareness of the challenges and opportunities presented by secondary fracture prevention to key stakeholders. The Best Practice Framework (BPF) sets an international benchmark for FLS, which defines essential and aspirational elements of service delivery. Results The BPF has been reviewed by leading experts from many countries and subject to beta-testing to ensure that it is internationally relevant and fit-for-purpose. The BPF will also serve as a measurement tool for IOF to award ‘Capture the Fracture Best Practice Recognition’ to celebrate successful FLS worldwide and drive service development in areas of unmet need. The Capture the Fracture website will provide a suite of resources related to FLS and secondary fracture prevention, which will be updated as new materials become available. A mentoring programme will enable those in the early stages of development of FLS to learn from colleagues elsewhere that have achieved Best Practice Recognition. A grant programme is in development to aid clinical systems which require financial assistance to establish FLS in their localities. Conclusion Nearly half a billion people will reach retirement age during the next 20 years. IOF has developed Capture the Fracture because this is the single most important thing that can be done to directly improve patient care, of both women and men, and reduce the spiralling fracture-related care costs worldwide.
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            Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data.

            Our falls prevention research group has conducted four controlled trials of a home exercise program to prevent falls in older people. The objectives of this meta-analysis of these trials were to estimate the overall effect of the exercise program on the numbers of falls and fall-related injuries and to identify subgroups that would benefit most from the program. We pooled individual-level data from the four trials to investigate the effect of the program in those aged 80 and older, in those with a previous fall, and in men and women. Nine cities and towns in New Zealand. One thousand sixteen community dwelling women and men aged 65 to 97. A program of muscle strengthening and balance retraining exercises designed specifically to prevent falls and individually prescribed and delivered at home by trained health professionals. Main outcomes were number of falls and number of injuries resulting from falls during the trials. The overall effect of the program was to reduce the number of falls and the number of fall-related injuries by 35% (incidence rate ratio (IRR) = 0.65, 95% confidence interval (CI) = 0.57-0.75; and, respectively IRR = 0.65, 95% CI = 0.53-0.81.) In injury prevention, participants aged 80 and older benefited significantly more from the program than those aged 65 to 79. The program was equally effective in reducing fall rates in those with and without a previous fall, but participants reporting a fall in the previous year had a higher fall rate (IRR = 2.34, 95% CI = 1.64-3.34). The program was equally effective in men and women. This exercise program was most effective in reducing fall-related injuries in those aged 80 and older and resulted in a higher absolute reduction in injurious falls when offered to those with a history of a previous fall.
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              Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women.

              To assess the effectiveness of a home exercise programme of strength and balance retraining exercises in reducing falls and injuries in elderly women. Randomised controlled trial of an individually tailored programme of physical therapy in the home (exercise group, n = 116) compared with the usual care and an equal number of social visits (control group, n = 117). 17 general practices in Dunedin, New Zealand. Women aged 80 years and older living in the community and registered with a general practice in Dunedin. Number of falls and injuries related to falls and time between falls during one year of follow up; changes in muscle strength and balance measures after six months. After one year there were 152 falls in the control group and 88 falls in the exercise group. The mean (SD) rate of falls was lower in the exercise than the control group (0.87 (1.29) v 1.34 (1.93) falls per year respectively; difference 0.47; 95% confidence interval 0.04 to 0.90). The relative hazard for the first four falls in the exercise group compared with the control group was 0.68 (0.52 to 0.90). The relative hazard for a first fall with injury in the exercise group compared with the control group was 0.61 (0.39 to 0.97). After six months, balance had improved in the exercise group (difference between groups in change in balance score 0.43 (0.21 to 0.65). An individual programme of strength and balance retraining exercises improved physical function and was effective in reducing falls and injuries in women 80 years and older.
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                Author and article information

                Contributors
                kilian.rapp@rbk.de
                karin.kampe@rbk.de
                patrick.roigk@rbk.de
                hella.kircheisen@rbk.de
                clemens.becker@rbk.de
                i.lindlbauer@uke.de
                h.koenig@uke.uni-hamburg.de
                dietrich.rothenbacher@uni-ulm.de
                gisela.buechele@uni-ulm.de
                Journal
                BMC Musculoskelet Disord
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                8 November 2016
                8 November 2016
                2016
                : 17
                : 458
                Affiliations
                [1 ]Department of Clinical Gerontology, Robert-Bosch-Hospital, Auerbachstr. 110, 70376 Stuttgart, Germany
                [2 ]Department of Medical Sociology and Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
                [3 ]Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
                [4 ]Institute of Epidemiology and Medical Biometry, Ulm University, Helmholtzstr. 22, 89081 Ulm, Germany
                Article
                1308
                10.1186/s12891-016-1308-0
                5100272
                27821102
                9cfc0673-3f45-44d4-a2ec-1cc562b98eb6
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 July 2016
                : 25 October 2016
                Funding
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404A
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404A
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404A
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404A
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404D
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404D
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404E
                Award Recipient :
                Funded by: Bundesministerium für Bildung und Forschung (BMBF)
                Award ID: Förderkennzeichen: 01 EC1404E
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Orthopedics
                accidental falls,fractures,osteoporosis,preventive health services,cluster-randomized
                Orthopedics
                accidental falls, fractures, osteoporosis, preventive health services, cluster-randomized

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