nach oben

Osteoporosis International

Erschienen in:

08.08.2018 | Original Article

Build better bones with exercise (B3E pilot trial): results of a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in older women with vertebral fracture

Erschienen in: Osteoporosis International | Ausgabe 11/2018

Einloggen, um Zugang zu erhalten

Abstract

Summary

We pilot-tested a trial of home exercise on individuals with osteoporosis and spine fracture.

Our target enrollment was met, though it took longer than expected. Participants stayed in the study and completed the exercise program with no safety concerns.

Future trials should expand the inclusion criteria and consider other changes.

Purpose

Osteoporotic fragility fractures create a substantial human and economic burden. There have been calls for a large randomized controlled trial examining the effect of exercise on fracture incidence. The B3E pilot trial was designed to evaluate the feasibility of a large trial examining the effects of home exercise on individuals at high risk of fracture.

Methods

Community-dwelling women ≥ 65 years with radiographically confirmed vertebral compression fractures were recruited at seven sites in Canada and Australia. We randomized participants in a 1:1 ratio to a 12-month home exercise program or equal attention control group, both delivered by a physiotherapist (PT). Participants received six PT home visits in addition to monthly phone calls from the PT and a blinded research assistant. The primary feasibility outcomes of the study were recruitment rate (20 per site in 1 year), retention rate (75% completion), and intervention adherence rate (60% of weeks meeting exercise goals). Secondary outcomes included falls, fractures and adverse events.

Results

One hundred forty-one participants were recruited; an average of 20 per site, though most sites took longer than anticipated. Retention and adherence met the criteria for success: 92% of participants completed the study; average adherence was 66%. The intervention group did not differ significantly in the number of falls (IRR 0.97, 95% CI 0.58 to 1.63) or fragility fractures (OR 1.11, 95% CI 0.60 to 2.05) compared to the control group. There were 18 serious adverse events in the intervention group and 12 in the control group.

Conclusion

An RCT of home exercise in women with vertebral fractures is feasible but recruitment was a challenge. Suggestions are made for the conduct of future trials.

Hernlund E, Svedbom A, Ivergård M et al (2013) Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 8:136. https://doi.org/10.1007/s11657-013-0136-1 CrossRefPubMedPubMedCentral

Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D (2000) Risk of mortality following clinical fractures. Osteoporos Int 11:556–561CrossRefPubMed

Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD (2009) Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ 181:265–271. https://doi.org/10.1503/cmaj.081720 CrossRefPubMedPubMedCentral

MacLean C, Newberry S, Maglione M, McMahon M, Ranganath V, Suttorp M, Mojica W, Timmer M, Alexander A, McNamara M, Desai SB, Zhou A, Chen S, Carter J, Tringale C, Valentine D, Johnsen B, Grossman J (2008) Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med 148:197–213. https://doi.org/10.7326/0003-4819-148-3-200802050-00198 CrossRefPubMed

Nevitt MC, Cummings SR, Stone KL, Palermo L, Black DM, Bauer DC, Genant HK, Hochberg MC, Ensrud KE, Hillier TA, Cauley JA (2004) Risk factors for a first-incident radiographic vertebral fracture in women ≥65 years of age: the study of osteoporotic fractures. J Bone Miner Res 20:131–140. https://doi.org/10.1359/JBMR.041003 CrossRefPubMed

Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, Hanley DA, Hodsman A, Jamal SA, Kaiser SM, Kvern B, Siminoski K, Leslie WD, for the Scientific Advisory Council of Osteoporosis Canada (2010) 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. Can Med Assoc J 182:1864–1873CrossRef

Gibbs JC, MacIntyre NJ, Templeton JA et al. Exercise for improving outcomes after osteoporotic vertebral fracture. Cochrane Database Syst Rev

Giangregorio LM, Papaioannou A, MacIntyre NJ et al (2014) Too fit to fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteoporos Int 25:821–835. https://doi.org/10.1007/s00198-013-2523-2 CrossRefPubMedPubMedCentral

Martyn-St James M, Carroll S (2008) Meta-analysis of walking for preservation of bone mineral density in postmenopausal women. Bone 43:521–531. https://doi.org/10.1016/j.bone.2008.05.012 CrossRefPubMed

10.

Martyn-St James M, Carroll S (2009) A meta-analysis of impact exercise on postmenopausal bone loss: the case for mixed loading exercise programmes. Br J Sports Med 43:898–908. https://doi.org/10.1136/bjsm.2008.052704 CrossRefPubMed

11.

Moayyeri A (2008) The association between physical activity and osteoporotic fractures: a review of the evidence and implications for future research

12.

Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G, Cochrane Musculoskeletal Group (2011) Exercise for preventing and treating osteoporosis in postmenopausal women. In: Howe TE (ed) Cochrane database of systematic reviews. Wiley, Chichester

13.

Kelley GA (1998) Exercise and regional bone mineral density in postmenopausal women: a meta-analytic review of randomized trials. Am J Phys Med Rehabil 77:76–87CrossRefPubMed

14.

Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR (2017) Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med 51:1750–1758. https://doi.org/10.1136/bjsports-2016-096547 CrossRefPubMed

15.

Faber MJ, Bosscher RJ, Chin A, Paw MJ, van Wieringen PC (2006) Effects of exercise programs on falls and mobility in frail and pre-frail older adults: a multicenter randomized controlled trial. Arch Phys Med Rehabil 87:885–896. https://doi.org/10.1016/j.apmr.2006.04.005 CrossRefPubMed

16.

Briggs AM, Greig AM, Wark JD (2007) The vertebral fracture cascade in osteoporosis: a review of aetiopathogenesis. Osteoporos Int 18:575–584. https://doi.org/10.1007/s00198-006-0304-x CrossRefPubMed

17.

Briggs AM, Wrigley TV, van Dieen JH et al (2006) The effect of osteoporotic vertebral fracture on predicted spinal loads in vivo. Eur Spine J 15:1785–1795. https://doi.org/10.1007/s00586-006-0158-0 CrossRefPubMed

18.

Papaioannou A, Adachi JD, Winegard K, Ferko N, Parkinson W, Cook RJ, Webber C, McCartney N (2003) Efficacy of home-based exercise for improving quality of life among elderly women with symptomatic osteoporosis-related vertebral fractures. Osteoporos Int 14:677–682. https://doi.org/10.1007/s00198-003-1423-2 CrossRefPubMed

19.

Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB (2004) Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA 292:837–846. https://doi.org/10.1001/jama.292.7.837 CrossRefPubMed

20.

Gold DT, Shipp KM, Pieper CF, Duncan PW, Martinez S, Lyles KW (2004) Group treatment improves trunk strength and psychological status in older women with vertebral fractures: results of a randomized, clinical trial. J Am Geriatr Soc 52:1471–1478. https://doi.org/10.1111/j.1532-5415.2004.52409.x CrossRefPubMed

21.

Hongo M, Itoi E, Sinaki M, Shimada Y, Miyakoshi N, Okada K (2005) Effects of reducing resistance, repetitions, and frequency of back-strengthening exercise in healthy young women: a pilot study. Arch Phys Med Rehabil 86:1299–1303CrossRefPubMed

22.

Liu C-J, Latham N (2010) Adverse events reported in progressive resistance strength training trials in older adults: 2 sides of a coin. Arch Phys Med Rehabil 91:1471–1473. https://doi.org/10.1016/j.apmr.2010.06.001 CrossRefPubMed

23.

Järvinen TLN, Sievänen H, Khan KM, Heinonen A, Kannus P (2008) Shifting the focus in fracture prevention from osteoporosis to falls. BMJ 336:124–126. https://doi.org/10.1136/bmj.39428.470752.AD CrossRefPubMedPubMedCentral

24.

El-Khoury F, Cassou B, Charles M-A, Dargent-Molina P (2013) The effect of fall prevention exercise programmes on fall induced injuries in community dwelling older adults: systematic review and meta-analysis of randomised controlled trials. BMJ 347:f6234. https://doi.org/10.1136/bmj.f6234 CrossRefPubMedPubMedCentral

25.

Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE, Cochrane Bone, Joint and Muscle Trauma Group (2012) Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev 12. https://doi.org/10.1002/14651858.CD007146.pub3

26.

Giangregorio LM, Thabane L, Adachi JD, Ashe MC, Bleakney RR, Braun EA, Cheung AM, Fraser LA, Gibbs JC, Hill KD, Hodsman AB, Kendler DL, Mittmann N, Prasad S, Scherer SC, Wark JD, Papaioannou A (2014) Build better bones with exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture. Phys Ther 94:1337–1352. https://doi.org/10.2522/ptj.20130625 CrossRefPubMedPubMedCentral

27.

Genant HK, Wu CY, van Kuijk C, Nevitt MC (1993) Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 8:1137–1148. https://doi.org/10.1002/jbmr.5650080915 CrossRefPubMed

28.

Leveille SG, Kiel DP, Jones RN, Roman A, Hannan MT, Sorond FA, Kang HG, Samelson EJ, Gagnon M, Freeman M, Lipsitz LA (2008) The MOBILIZE Boston Study: design and methods of a prospective cohort study of novel risk factors for falls in an older population. BMC Geriatr 8:16. https://doi.org/10.1186/1471-2318-8-16 CrossRefPubMedPubMedCentral

29.

Schousboe JT, Vokes T, Broy SB, Ferrar L, McKiernan F, Roux C, Binkley N (2008) Vertebral fracture assessment: the 2007 ISCD official positions. J Clin Densitom 11:92–108. https://doi.org/10.1016/j.jocd.2007.12.008 CrossRefPubMed

30.

Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A (2000) The mini-cog: a cognitive “vital signs” measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry 15:1021–1027CrossRefPubMed

31.

Lach HW, Reed AT, Arfken CL, Miller JP, Paige GD, Birge SJ, Peck WA (1991) Falls in the elderly: reliability of a classification system. J Am Geriatr Soc 39:197–202CrossRefPubMed

32.

Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85–M94CrossRefPubMed

33.

Baert V, Gorus E, Mets T, Bautmans I (2015) Motivators and barriers for physical activity in older adults with osteoporosis. J Geriatr Phys Ther 38:105–114. https://doi.org/10.1519/JPT.0000000000000035 CrossRefPubMed

34.

Simmonds BAJ, Hannam KJ, Fox KR, Tobias JH (2016) An exploration of barriers and facilitators to older adults’ participation in higher impact physical activity and bone health: a qualitative study. Osteoporos Int 27:979–987. https://doi.org/10.1007/s00198-015-3376-7 CrossRefPubMed

35.

Rodrigues IB, Armstrong JJ, Adachi JD, MacDermid JC (2016) Facilitators and barriers to exercise adherence in patients with osteopenia and osteoporosis: a systematic review. Osteoporos Int 28:735–745. https://doi.org/10.1007/s00198-016-3793-2 CrossRefPubMed

36.

Leslie WD, Berger C, Langsetmo L et al (2011) Construction and validation of a simplified fracture risk assessment tool for Canadian women and men: results from the CaMos and Manitoba cohorts. Osteoporos Int 22:1873–1883. https://doi.org/10.1007/s00198-010-1445-5 CrossRefPubMed

37.

Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E (2008) FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int 19:385–397. https://doi.org/10.1007/s00198-007-0543-5 CrossRefPubMedPubMedCentral

38.

Bergland A, Thorsen H, Kåresen R (2011) Effect of exercise on mobility, balance, and health-related quality of life in osteoporotic women with a history of vertebral fracture: a randomized, controlled trial. Osteoporos Int

39.

Evstigneeva L, Lesnyak O, Bultink IEM, Lems WF, Kozhemyakina E, Negodaeva E, Guselnikova G, Belkin A (2016) Effect of twelve-month physical exercise program on patients with osteoporotic vertebral fractures: a randomized, controlled trial. Osteoporos Int 27:2515–2524. https://doi.org/10.1007/s00198-016-3560-4 CrossRefPubMed

40.

Wang X, Xu B, Ye X, Yang YY, Wang GH (2015) Effects of different treatments on patients with osteoporotic fracture after percutaneous kyphoplasty. Zhongguo Gu Shang 28:512–516PubMed

41.

Shipp K, Gold D, Pieper C, Lyles K (2007) Improving trunk strength and endurance in older women with vertebral fractures. J Bone Miner Res

42.

Bennell KL, Matthews B, Greig A, Briggs A, Kelly A, Sherburn M, Larsen J, Wark J (2010) Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial. BMC Musculoskelet Disord 11:36. https://doi.org/10.1186/1471-2474-11-36 CrossRefPubMedPubMedCentral

43.

Lamb SE, Jorstad-Stein EC, Hauer K, Becker C (2005) Development of a common outcome data set for fall injury prevention trials: the prevention of falls network Europe consensus. J Am Geriatr Soc 53:1618–1622. https://doi.org/10.1111/j.1532-5415.2005.53455.x CrossRefPubMed

44.

Ziebart C, McArthur C, Lee L, Papaioannou A, Laprade J, Cheung AM, Jain R, Giangregorio L (2018) “Left to my own devices, I don’t know”: using theory and patient-reported barriers to move from physical activity recommendations to practice. Osteoporos Int 29:1081–1091. https://doi.org/10.1007/s00198-018-4390-3 CrossRefPubMed

45.

El-Khoury F, Cassou B, Latouche A et al (2015) Effectiveness of two year balance training programme on prevention of fall induced injuries in at risk women aged 75-85 living in community: Ossebo randomised controlled trial. BMJ 351:h3830CrossRefPubMedPubMedCentral

46.

Giangregorio LM, MacIntyre NJ, Heinonen A et al (2014) Too fit to fracture: a consensus on future research priorities in osteoporosis and exercise. Osteoporos Int 25:1465–1472. https://doi.org/10.1007/s00198-014-2652-2 CrossRefPubMedPubMedCentral

Titel: Build better bones with exercise (B3E pilot trial): results of a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in older women with vertebral fracture
Publikationsdatum: 08.08.2018
Erschienen in: Osteoporosis International / Ausgabe 11/2018
Print ISSN: 0937-941X
Elektronische ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-018-4652-0

Arthropedia

Grundlagenwissen der Arthroskopie und Gelenkchirurgie. Erweitert durch Fallbeispiele, Videos und Abbildungen.
» Jetzt entdecken

Neu im Fachgebiet Orthopädie und Unfallchirurgie

25.04.2024 | Hypertonie | Nachrichten

Update Orthopädie und Unfallchirurgie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen

Springer Medizin

Build better bones with exercise (B3E pilot trial): results of a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in older women with vertebral fracture

Abstract

Summary

Purpose

Methods

Results

Conclusion

Arthropedia

Neu im Fachgebiet Orthopädie und Unfallchirurgie

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

Ärztliche Empathie hilft gegen Rückenschmerzen

Stereotaktische Radiatio schlägt konventionelle Bestrahlung

Vorsicht mit hohen NSAR-Dosen bei ankylosierender Spondylitis!

Update Orthopädie und Unfallchirurgie

Springer Medizin

Abstract

Summary

Purpose

Methods

Results

Conclusion

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 11/2018

Association between use of antidepressants or benzodiazepines and the risk of subsequent fracture among those aged 65+ in the Netherlands

VITamin D and OmegA-3 TriaL (VITAL) bone health ancillary study: clinical factors associated with trabecular bone score in women and men

Correction to: Differences in bone quality and strength between Asian and Caucasian young men

Decreasing trend of bone mineral density in US multiethnic population: analysis of continuous NHANES 2005–2014

Does primary lactase deficiency reduce bone mineral density in postmenopausal women? A systematic review and meta-analysis

Post-traumatic stress disorder and incident fractures in the Danish population

Arthropedia

Neu im Fachgebiet Orthopädie und Unfallchirurgie

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

Ärztliche Empathie hilft gegen Rückenschmerzen

Stereotaktische Radiatio schlägt konventionelle Bestrahlung

Vorsicht mit hohen NSAR-Dosen bei ankylosierender Spondylitis!

Update Orthopädie und Unfallchirurgie