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Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures.

ABSTRACT: Osteoporosis affects over 220 million people worldwide, and currently there is no 'cure' for the disease. Thus, there is a need to develop evidence-based, safe and acceptable prevention strategies at the population level that target multiple risk factors for fragility fractures to reduce the health and economic burden of the condition.The Osteo-cise: Strong Bones for Life study will investigate the effectiveness and feasibility of a multi-component targeted exercise, osteoporosis education/awareness and behavioural change program for improving bone health and muscle function and reducing falls risk in community-dwelling older adults at an increased risk of fracture. Men and women aged ?60 years will participate in an 18-month randomised controlled trial comprising a 12-month structured and supervised community-based program and a 6-month 'research to practise' translational phase. Participants will be randomly assigned to either the Osteo-cise intervention or a self-management control group. The intervention will comprise a multi-modal exercise program incorporating high velocity progressive resistance training, moderate impact weight-bearing exercise and high challenging balance exercises performed three times weekly at local community-based fitness centres. A behavioural change program will be used to enhance exercise adoption and adherence to the program. Community-based osteoporosis education seminars will be conducted to improve participant knowledge and understanding of the risk factors and preventative measures for osteoporosis, falls and fractures. The primary outcomes measures, to be collected at baseline, 6, 12, and 18 months, will include DXA-derived hip and spine bone mineral density measurements and functional muscle power (timed stair-climb test). Secondary outcomes measures include: MRI-assessed distal femur and proximal tibia trabecular bone micro-architecture, lower limb and back maximal muscle strength, balance and function (four square step test, functional reach test, timed up-and-go test and 30-second sit-to-stand), falls incidence and health-related quality of life. Cost-effectiveness will also be assessed.The findings from the Osteo-cise: Strong Bones for Life study will provide new information on the efficacy of a targeted multi-modal community-based exercise program incorporating high velocity resistance training, together with an osteoporosis education and behavioural change program for improving multiple risk factors for falls and fracture in older adults at risk of fragility fracture.Australian New Zealand Clinical Trials Registry reference ACTRN12609000100291.

SUBMITTER: Gianoudis J

PROVIDER: S-EPMC3544181 | biostudies-other | 2012 May

REPOSITORIES: biostudies-other

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Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures.

Gianoudis Jenny J Bailey Christine A CA Sanders Kerrie M KM Nowson Caryl A CA Hill Keith K Ebeling Peter R PR Daly Robin M RM

BMC musculoskeletal disorders 20120528

<h4>Background</h4>Osteoporosis affects over 220 million people worldwide, and currently there is no 'cure' for the disease. Thus, there is a need to develop evidence-based, safe and acceptable prevention strategies at the population level that target multiple risk factors for fragility fractures to reduce the health and economic burden of the condition.<h4>Methods/design</h4>The Osteo-cise: Strong Bones for Life study will investigate the effectiveness and feasibility of a multi-component targe ...[more]

PMID: 22640372

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Project description:BackgroundHome exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known. The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital.Methods and findingsThis randomised controlled trial (ACTRN12607000563460) was conducted among 340 older people. Intervention group participants (n?=?171) were asked to exercise at home for 15-20 minutes up to 6 times weekly for 12 months. The control group (n?=?169) received usual care. Primary outcomes were rate of falls (assessed over 12 months using monthly calendars), performance-based mobility (Lower Extremity Summary Performance Score, range 0-3, at baseline and 12 months, assessor unaware of group allocation) and self-reported ease of mobility task performance (range 0-40, assessed with 12 monthly questionaries). Participants had an average age of 81.2 years (SD 8.0) and 70% had fallen in the past year. Complete primary outcome data were obtained for at least 92% of randomised participants. Participants in the intervention group reported more falls than the control group (177 falls versus 123 falls) during the 12-month study period and this difference was statistically significant (incidence rate ratio 1.43, 95% CI 1.07 to 1.93, p?=?0.017). At 12-months, performance-based mobility had improved significantly more in the intervention group than in the control group (between-group difference adjusted for baseline performance 0.13, 95% CI 0.04 to 0.21, p?=?0.004). Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups (0.49, 95% CI -0.91 to 1.90, p?=?0.488).ConclusionsAn individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12607000563460.

Project description:BACKGROUND:Lifelong healthy habits developed during childhood may prevent chronic diseases in adulthood. Interventions to promote these habits must begin early. The BONES (Beat Osteoporosis - Nourish and Exercise Skeletons) project assessed whether early elementary school children participating in a multifaceted health behavior change, after-school based intervention would improve bone quality and muscular strength and engage in more bone-strengthening behaviors. METHODS:The 2-year BONES (B) intervention included bone-strengthening physical activity (85?min/week), educational materials (2?days/week), and daily calcium-rich snacks (380?mg calcium/day) delivered by after-school program leaders. BONES plus Parent (B?+?P) included an additional parent education component. From 1999 to 2004, n?=?83 after-school programs (N?=?1434 children aged 6-9?years) in Massachusetts and Rhode Island participated in a group randomized trial with two intervention arms (B only, n?=?25 programs; B?+?P, n?=?33) and a control arm (C, n?=?25). Outcome measures (primary: bone quality (stiffness index of the calcaneus) and muscular strength (grip strength and vertical jump); secondary: bone-strengthening behaviors (calcium-rich food knowledge, preference, and intake; and physical activity level (metabolic equivalent time (MET) score, and weight-bearing factor (WBF) score)) were recorded at baseline, and after years one and two. Analyses followed an intent-to-treat protocol, and focused on individual subjects' trajectories along the three time points adjusting for baseline age and race via a mixed-effects regression framework. Analyses were performed with and without sex stratification. RESULTS:Children in B?+?P increased bone stiffness compared to C (p?=?0.05); No significant changes were observed in muscle strength, food knowledge, or vertical jump. Children in B?+?P showed significant improvement in their MET and WBF scores compared to C (p?<?0.01) with a stronger effect in boys in both B and B?+?P (all p?<?0.01). CONCLUSION:After-school programs, coupled with parental engagement, serving early elementary school children are a potentially feasible platform to deliver bone-strengthening behaviors to prevent osteoporosis in adulthood, with some encouraging bone and physical activity outcomes. TRIAL REGISTRATION:ClinicalTrials.gov NCT00065247. Retrospectively registered. First posted July 22, 2003.

Project description:Simulation-based education (SBE) is now commonly used across health professional disciplines to teach a range of skills. The evidence base supporting the effectiveness of this approach for improving patient health outcomes is relatively narrow, focused mainly on the development of procedural skills. However, there are other simulation approaches used to support non-procedure specific skills that are in need of further investigation. This cluster, cross-over randomised controlled trial with a concurrent economic evaluation (cost per fall prevented) trial will evaluate the effectiveness, cost-effectiveness and student experience of health professional students undertaking simulation training for the prevention of falls among hospitalised inpatients. This research will target the students within the established undergraduate student placements of Monash University medicine, nursing and allied health across Peninsula Health acute and subacute inpatient wards.The intervention will train the students in how to provide the Safe Recovery program, the only single intervention approach demonstrated to reduce falls in hospitals. This will involve redevelopment of the Safe Recovery program into a one-to-many participant SBE program, so that groups of students learn the communication skills and falls prevention knowledge necessary for delivery of the program. The primary outcome of this research will be patient falls across participating inpatient wards, with secondary outcomes including student satisfaction with the SBE and knowledge gain, ward-level practice change and cost of acute/rehabilitation care for each patient measured using clinical costing data.The Human Research Ethics Committees of Peninsula Health (LRR/15/PH/11) and Monash University (CF15/3523-2015001384) have approved this research. The participant information and consent forms provide information on privacy, storage of results and dissemination. Registration of this trial has been completed with the Australian and New Zealand Clinical Trials Registry: ACTRN12615000817549. This study protocol has been prepared according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.ACTRN12615000817549; Pre-results.

Project description:OBJECTIVE:To investigate the effect of whole-body vibration exercise (WBV) on fracture risk in adults ≥50 years of age. DESIGN:A systematic review and meta-analysis calculating relative risk ratios, fall rate ratio and absolute weighted mean difference using random effects models. Heterogeneity was estimated using I2 statistics, and the Cochrane Collaboration's risk of bias tool and the GRADE approach were used to evaluate quality of evidence and summarise conclusions. DATA SOURCES:The databases PubMed, Embase and the Cochrane Central Register from inception to April 2016 and reference lists of retrieved publications. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:Randomised controlled trials examining the effect of WBV on fracture risk in adults ≥50 years of age. The primary outcomes were fractures, fall rates and the proportion of participants who fell. Secondary outcomes were bone mineral density (BMD), bone microarchitecture, bone turnover markers and calcaneal broadband attenuation (BUA). RESULTS:15 papers (14 trials) met the inclusion criteria. Only one study had fracture data reporting a non-significant fracture reduction (risk ratio (RR)=0.47, 95% CI 0.14 to 1.57, P=0.22) (moderate quality of evidence). Four studies (n=746) showed that WBV reduced the rate of falls with a rate ratio of 0.67 (95% CI 0.50 to 0.89, P=0.0006; I2=19%) (moderate quality of evidence). Furthermore, data from three studies (n=805) found a trend towards falls reduction (RR=0.76, 95% CI 0.48 to 1.20, P=0.24; I2=24%) (low quality of evidence). Finally, moderate to low quality of evidence showed no overall effect on BMD and only sparse data were available regarding microarchitecture parameters, bone turnover markers and BUA. CONCLUSIONS:WBV reduces fall rate but seems to have no overall effect on BMD or microarchitecture. The impact of WBV on fractures requires further larger adequately powered studies. This meta-analysis suggests that WBV may prevent fractures by reducing falls. PROSPERO REGISTRATION NUMBER:CRD42016036320; Pre-results.

Dataset Information

Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures.

Publications

Osteo-cise: strong bones for life: protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures.

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