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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2012

Open Access 01-12-2012 | Study protocol

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

Authors: Jenny Gianoudis, Christine A Bailey, Kerrie M Sanders, Caryl A Nowson, Keith Hill, Peter R Ebeling, Robin M Daly

Published in: BMC Musculoskeletal Disorders | Issue 1/2012

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Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

Australian New Zealand Clinical Trials Registry reference ACTRN12609000100291
Appendix
Available only for authorised users
Literature
1.
Henry MJ, Pasco JA, Nicholson GC, Kotowicz MA: Prevalence of osteoporosis in Australian men and women: Geelong Osteoporosis Study. Med J Australia. 2011, 195 (6): 321-322.CrossRefPubMed
2.
Ebeling PR, Haikerwal A, Stenmark J, Walker M: The Burden of Brittle Bones Epidemiology, Costs & Burden of Osteoporosis in Australia – 2007. 2007, Melbourne: Access Economics Pty Ltd.
3.
Haleem S, Lutchman L, Mayahi R, Grice JE, Parker MJ: Mortality following hip fracture: Trends and geographical variations over the last 40 years. Injury. 2008, 39 (10): 1157-1163. 10.1016/j.injury.2008.03.022.CrossRefPubMed
4.
van Balen R, Steyerberg EW, Polder JJ, Ribbers TLM, Habbema JDF, Cools HJM: Hip fracture in elderly patients - Outcomes for function, quality of life, and type of residence. Clin Orthop Rel Res. 2001, 390: 232-243.CrossRef
5.
Sanders KM, Nicholson GC, Watts JJ, Pasco JA, Henry MJ, Kotowicz MA, Seeman E: Half the burden of fragility fractures in the community occur in women without osteoporosis. When is fracture prevention cost-effective?. Bone. 2006, 38 (5): 694-700. 10.1016/j.bone.2005.06.004.CrossRefPubMed
6.
Rahman N, Penm E, Bhatia K: Arthritis and musculoskeletal conditions in Australia, In ARTHRITIS SERIES Number 1. 2005, Canberra: Australian Institute of Health and Welfare, 2005-
7.
Sambrook PN, Cameron ID, Chen JS, Cumming RG, Lord SR, March LM, Schwarz J, Seibel MJ, Simpson JM: Influence of fall related factors and bone strength on fracture risk in the frail elderly. Osteoporosis Int. 2007, 18 (5): 603-610. 10.1007/s00198-006-0290-z.CrossRef
8.
Kohrt WM, Bloomfield SA, Little KD, Nelson ME, Yingling VR: American College of Sports Medicine. Position Stand. Physical Activity and Bone Health. Med Sci Sports Exer. 2004, 36 (11): 1985-1996. 10.1249/01.MSS.0000142662.21767.58.CrossRef
9.
Martyn-St James M, Carroll S: A meta-analysis of impact exercise on postmenopausal bone loss: the case for mixed loading exercise programmes. Brit J Sports Med. 2009, 43 (12): 898-908. 10.1136/bjsm.2008.052704.CrossRef
10.
Macaluso A, De Vito G: Muscle strength, power and adaptations to resistance training in older people. Eur J Appl Physiol. 2004, 91 (4): 450-472. 10.1007/s00421-003-0991-3.CrossRefPubMed
11.
Martyn-St James M, Carroll S: High-intensity resistance training and postmenopausal bone loss: a meta-analysis. Osteoporosis Int. 2006, 17 (8): 1225-1240. 10.1007/s00198-006-0083-4.CrossRef
12.
Wallace BA, Cumming RG: Systematic review of randomized trials of the effect of exercise on bone mass in pre- and postmenopausal women. Calcif Tissue Int. 2000, 67 (1): 10-18. 10.1007/s00223001089.CrossRefPubMed
13.
Latham NK, Bennett DA, Stretton CM, Anderson CS: Systematic review of progressive resistance strength training in older adults. J Gerontol A Biol Sci Med Sci. 2004, 59 (1): 48-61. 10.1093/gerona/59.1.M48.CrossRefPubMed
14.
Orr R, Raymond J, Fiatarone Singh M: Efficacy of progressive resistance training on balance performance in older adults : a systematic review of randomized controlled trials. Sports Med. 2008, 38 (4): 317-343. 10.2165/00007256-200838040-00004.CrossRefPubMed
15.
Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JCT: Effective Exercise for the Prevention of Falls: A Systematic Review and Meta-Analysis. J Am Geriatr Soc. 2008, 56 (12): 2234-2243. 10.1111/j.1532-5415.2008.02014.x.CrossRefPubMed
16.
Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P: Increased rate of force development and neural drive of human skeletal muscle following resistance training. J Appl Physiol. 2002, 93 (4): 1318-1326.CrossRefPubMed
17.
Foldvari M, Clark M, Laviolette LC, Bernstein MA, Kaliton D, Castaneda C, Pu CT, Hausdorff JM, Fielding RA, Singh MA: Association of muscle power with functional status in community-dwelling elderly women. J Gerontol A Biol Sci Med Sci. 2000, 55 (4): M192-M199. 10.1093/gerona/55.4.M192.CrossRefPubMed
18.
Skelton DA, Kennedy J, Rutherford OM: Explosive power and asymmetry in leg muscle function in frequent fallers and non-fallers aged over 65. Age Ageing. 2002, 31 (2): 119-125. 10.1093/ageing/31.2.119.CrossRefPubMed
19.
Rice J, Keogh JWL: Power Training: Can it Improve Functional Performance in Older Adults? A Systematic Review. Int J Exerc Sci. 2009, 2 (2): 131-151.
20.
von Stengel S, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K: Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol. 2005, 99 (1): 181-188. 10.1152/japplphysiol.01260.2004.CrossRef
21.
Parkkari J, Kannus P, Palvanen M, Natri A, Vainio J, Aho H, Vuori I, Jarvinen M: Majority of hip fractures occur as a result of a fall and impact on the greater trochanter of the femur: A prospective controlled hip fracture study with 206 consecutive patients. Calcif Tissue Int. 1999, 65 (3): 183-187. 10.1007/s002239900679.CrossRefPubMed
22.
Youm T, Koval KJ, Kummer FJ, Zuckerman JD: Do all hip fractures result from a fall?. Am J Orthop (Belle Mead, NJ). 1999, 28 (3): 190-194.
23.
Cripps R, Carman J: Falls by the elderly in Australia: Trends and data for 1998. Injury Research and Statistics Series, Adelaide Australian Institute of Health and Welfare (AIHW cat no INJCAT 35). 2001
24.
Lord SR, Sherrington C, Menz H, Close JCT: Falls in Older People: Risk factors and strategies for prevention. 2007, Cambridge, UK: Cambridge University Press, 2CrossRef
25.
Close J, Lord S: How to treat. Falls in the elderly. Australian Doctor. March 2006, 2006 (3): 27-32.
26.
Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR: Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011, 22 (3–4): 78-83.CrossRefPubMed
27.
Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S: Cumming RG. 2009, Rowe BH: Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev, (2)
28.
Cress ME, Buchner DM, Prohaska T, Rimmer J, Brown M, Macera C, DiPietro L, Chodzko-Zajko W: Best practices for physical activity programs and behavior counseling in older adult populations. J Aging Physical Activity. 2005, 13 (1): 61-74.
29.
King AC, Rejeski WJ, Buchner DM: Physical activity interventions targeting older adults - A critical review and recommendations. Am J Prev Med. 1998, 15 (4): 316-333. 10.1016/S0749-3797(98)00085-3.CrossRefPubMed
30.
Bandura A: Social foundations of thought and action. 1986, A social cognitive theory. Englewood Cliffs ML: Prentice Hall
31.
Prochaska JO, Velicer WF: The transtheoretical model of health behavior change. Am J Health Prom. 1997, 12 (1): 38-48. 10.4278/0890-1171-12.1.38.CrossRef
32.
Rolnick SJ, Kopher R, Jackson J, Fischer LR, Compo R: What is the impact of osteoporosis education and bone mineral density testing for postmenopausal women in a managed care setting. Menopause. 2001, 8 (2): 141-148. 10.1097/00042192-200103000-00010.CrossRefPubMed
33.
Winzenberg T, Oldenburg B, Frendin S, De Wit L, Riley M, Jones G: The effect on behavior and bone mineral density of individualized bone mineral density feedback and educational interventions in premenopausal women: a randomized controlled trial NCT00273260. BMC Publ Health. 2006, 6: 12-10.1186/1471-2458-6-12.CrossRef
34.
Sanders KM, Stuart AL, Merriman EN, Read ML, Kotowicz MA, Young D, Taylor R, Blair-Holt I, Mander AG, Nicholson GC: Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study. BMC Medical Research Methodology. 2009, 9: 78-10.1186/1471-2288-9-78.CrossRefPubMedPubMedCentral
35.
Daly RM, Brown M, Bass S, Kukuljan S, Nowson C: Calcium- and vitamin D-3-fortified milk reduces bone loss at clinically relevant skeletal sites in older men: A 2-year randomized controlled trial. J Bone Miner Res. 2006, 21 (3): 397-405.CrossRefPubMed
36.
Kukuljan S, Nowson CA, Bass SL, Sanders K, Nicholson GC, Seibel MJ, Salmon J, Daly RM: Effects of a multi-component exercise program and calcium-vitamin-D-3-fortified milk on bone mineral density in older men: a randomised controlled trial. Osteoporosis Int. 2009, 20 (7): 1241-1251. 10.1007/s00198-008-0776-y.CrossRef
37.
Kukuljan S, Nowson CA, Sanders KM, Nicholson GC, Seibel MJ, Salmon J, Daly RM: Independent and Combined Effects of Calcium-Vitamin D-3 and Exercise on Bone Structure and Strength in Older Men: An 18-Month Factorial Design Randomized Controlled Trial. J Clin Endocrinol Metab. 2011, 96 (4): 955-963. 10.1210/jc.2010-2284.CrossRefPubMed
38.
Kibler WB, Press J, Sciascia A: The Role of Core Stability in Athletic Function. Sports Med. 2006, 36 (3): 189-198. 10.2165/00007256-200636030-00001.CrossRefPubMed
39.
Baker MK, Kennedy DJ, Bohle PL, Campbell DS, Knapman L, Grady J, Wiltshire J, McNamara M, Evans WJ, Atlantis E: Efficacy and feasibility of a novel tri-modal robust exercise prescription in a retirement community: a randomized, controlled trial. J Am Geriatr Soc. 2007, 55 (1): 1-10. 10.1111/j.1532-5415.2006.01031.x.CrossRefPubMed
40.
Hologic: QDR for Windows XP Reference Manual. 2006, Bedford, MA, USA: Hologic, Inc
41.
Bean JF, Kiely DK, LaRose S, Alian J, Frontera WR: Is Stair Climb Power a Clinically Relevant Measure of Leg Power Impairments in At-Risk Older Adults?. Arch Phys Med Rehab. 2007, 88 (5): 604-609. 10.1016/j.apmr.2007.02.004.CrossRef
42.
Lazowski DA, Ecclestone NA, Myers AM, Paterson DH, Tudor-Locke C, Fitzgerald C, Jones G, Shima N, Cunningham DA: A randomized outcome evaluation of group exercise programs in long-term care institutions. J Gerontol A Biol Sci Med Sci. 1999, 54 (12): M621-M628. 10.1093/gerona/54.12.M621.CrossRefPubMed
43.
Wathen D: Load assignment. 1994, Champaign, IL: Human Kinetics
44.
Dite W, Temple VA: A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehab. 2002, 83 (11): 1566-1571. 10.1053/apmr.2002.35469.CrossRef
45.
Podsiadlo D, Richardson S: The timed up and go - a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991, 39 (2): 142-148.CrossRefPubMed
46.
Shumway-Cook A, Brauer S, Woollacott M: Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000, 80 (9): 896-903.PubMed
47.
Jones CJ, Rikli RE, Beam WC: A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Research Quarterly for Exercise and Sport. 1999, 70 (2): 113-119.CrossRefPubMed
48.
Duncan PW, Weiner DK, Chandler J, Studenski S: Functional reach - a new clinical measure of balance. J Gerontol. 1990, 45 (6): M192-M197. 10.1093/geronj/45.6.M192.CrossRefPubMed
49.
Ashburn A, Stack E, Pickering RM, Ward CD: A community-dwelling sample of people with Parkinson’s disease: characteristics of fallers and non-fallers. Age Ageing. 2001, 30 (1): 47-52. 10.1093/ageing/30.1.47.CrossRefPubMed
50.
Smithson F, Morris ME, Iansek R: Performance on clinical tests balance in Parkinson’s disease. Phys Ther. 1998, 78 (6): 577-592.PubMed
51.
Newitt DC, van Rietbergen B, Majumdar S: Processing and analysis of in vivo high-resolution MR images of trabecular bone for longitudinal studies: Reproducibility of structural measures and micro-finite element analysis derived mechanical properties. Osteoporosis Int. 2002, 13 (4): 278-287. 10.1007/s001980200027.CrossRef
52.
Majumdar S, Newitt D, Jergas M, Gies A, Chiu E, Osman D, Keltner J, Keyak J, Genant H: Evaluation of technical factors affecting the quantification of trabecular bone-structure using magnetic-resonance-imaging. Bone. 1995, 17 (4): 417-430. 10.1016/S8756-3282(95)00263-4.CrossRefPubMed
53.
Lindsey CT, Narasimhan A, Adolfo JM, Jin H, Steinbach LS, Link T, Ries M, Majumdar S: Magnetic resonance evaluation of the interrelationship between articular cartilage and trabecular bone of the osteoarthritic knee. Osteoarthr Cartil. 2004, 12 (2): 86-96. 10.1016/j.joca.2003.10.009.CrossRefPubMed
54.
Tinetti M, Baker D, Dutcher J, Vincent J, Rozett R: Reducing the risk of falls among older adults in the community. 1997, Berkeley, CA: Peaceable Kingdom Press
55.
Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL: CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001, 33 (7): 1126-1141.CrossRefPubMed
56.
Brooks R: EuroQol: the current state of play. Health Policy. 1996, 37 (1): 53-72. 10.1016/0168-8510(96)00822-6.CrossRefPubMed
57.
Viney R, Norman R, King MT, Cronin P, Street DJ, Knox S, Ratcliffe J: Time trade-off derived EQ-5D weights for Australia. Value Health. 2011, 14 (6): 928-936. 10.1016/j.jval.2011.04.009.CrossRefPubMed
58.
Winzenberg TM, Oldenburg B, Frendin S, Jones G: The design of a valid and reliable questionnaire to measure osteoporosis knowledge in women: the Osteoporosis Knowledge Assessment Tool (OKAT). BMC Musculoskelet Disord. 2003, 4:
59.
Kim KK, Horan ML, Gendler P, Patel MK: Development and evaluation of the osteoporosis health belief scale. Res Nurs Heal. 1991, 14 (2): 155-163. 10.1002/nur.4770140210.CrossRef
60.
Ware JE, Gandek B, Project I: Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998, 51 (11): 903-912. 10.1016/S0895-4356(98)00081-X.CrossRefPubMed
Metadata
Title
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
Authors
Jenny Gianoudis
Christine A Bailey
Kerrie M Sanders
Caryl A Nowson
Keith Hill
Peter R Ebeling
Robin M Daly
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2012
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-13-78

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