Osteoporosis International

, Volume 29, Issue 11, pp 2545–2556 | Cite as

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

  • L.M. GiangregorioEmail author
  • J.C. Gibbs
  • J.A. Templeton
  • J.D. Adachi
  • M.C. Ashe
  • R.R. Bleakney
  • A.M. Cheung
  • K.D. Hill
  • D.L. Kendler
  • A. A. Khan
  • S. Kim
  • C. McArthur
  • N. Mittmann
  • A. Papaioannou
  • S. Prasad
  • S.C. Scherer
  • L. Thabane
  • J.D. Wark
Original Article



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.


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.


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.


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.


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.


Aged Exercise Feasibility Female Osteoporosis RCT 



The research was funded by a CIHR Operating grant (MOP 123445). Dr. Giangregorio received funding from an Ontario Ministry of Health Research and Innovation–Early Researcher Award, a CIHR New Investigator Award, and the Canadian Foundation for Innovation. Dr. Ashe acknowledges the support of the Canada Research Chairs program. Dr. Gibbs received funding from a CIHR Fellowship Award.

Compliance with ethical standards

All participants gave their informed, written consent and the study was approved by the research ethics board of each enrolling center

Conflict of interest



  1. 1.
    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. CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D (2000) Risk of mortality following clinical fractures. Osteoporos Int 11:556–561CrossRefGoogle Scholar
  3. 3.
    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. CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    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. CrossRefPubMedGoogle Scholar
  5. 5.
    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. CrossRefPubMedGoogle Scholar
  6. 6.
    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 182:1864–1873CrossRefGoogle Scholar
  7. 7.
    Gibbs JC, MacIntyre NJ, Templeton JA et al. Exercise for improving outcomes after osteoporotic vertebral fracture. Cochrane Database Syst RevGoogle Scholar
  8. 8.
    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. CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Martyn-St James M, Carroll S (2008) Meta-analysis of walking for preservation of bone mineral density in postmenopausal women. Bone 43:521–531. CrossRefPubMedGoogle Scholar
  10. 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. CrossRefPubMedGoogle Scholar
  11. 11.
    Moayyeri A (2008) The association between physical activity and osteoporotic fractures: a review of the evidence and implications for future researchGoogle Scholar
  12. 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, ChichesterGoogle Scholar
  13. 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 77:76–87CrossRefGoogle Scholar
  14. 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. CrossRefPubMedGoogle Scholar
  15. 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. CrossRefPubMedGoogle Scholar
  16. 16.
    Briggs AM, Greig AM, Wark JD (2007) The vertebral fracture cascade in osteoporosis: a review of aetiopathogenesis. Osteoporos Int 18:575–584. CrossRefGoogle Scholar
  17. 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. CrossRefGoogle Scholar
  18. 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. CrossRefPubMedGoogle Scholar
  19. 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. CrossRefPubMedGoogle Scholar
  20. 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. CrossRefPubMedGoogle Scholar
  21. 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 86:1299–1303CrossRefGoogle Scholar
  22. 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. CrossRefPubMedGoogle Scholar
  23. 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. CrossRefPubMedPubMedCentralGoogle Scholar
  24. 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. CrossRefPubMedPubMedCentralGoogle Scholar
  25. 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.
  26. 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. CrossRefPubMedPubMedCentralGoogle Scholar
  27. 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. CrossRefPubMedGoogle Scholar
  28. 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. CrossRefPubMedPubMedCentralGoogle Scholar
  29. 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. CrossRefPubMedGoogle Scholar
  30. 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 15:1021–1027CrossRefGoogle Scholar
  31. 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 39:197–202CrossRefGoogle Scholar
  32. 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–M94CrossRefGoogle Scholar
  33. 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. CrossRefPubMedGoogle Scholar
  34. 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. CrossRefPubMedGoogle Scholar
  35. 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. CrossRefPubMedGoogle Scholar
  36. 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. CrossRefPubMedGoogle Scholar
  37. 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. CrossRefPubMedPubMedCentralGoogle Scholar
  38. 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 IntGoogle Scholar
  39. 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. CrossRefPubMedGoogle Scholar
  40. 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 28:512–516PubMedGoogle Scholar
  41. 41.
    Shipp K, Gold D, Pieper C, Lyles K (2007) Improving trunk strength and endurance in older women with vertebral fractures. J Bone Miner ResGoogle Scholar
  42. 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. CrossRefPubMedPubMedCentralGoogle Scholar
  43. 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. CrossRefPubMedGoogle Scholar
  44. 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. CrossRefPubMedGoogle Scholar
  45. 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:h3830CrossRefGoogle Scholar
  46. 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. CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2018

Authors and Affiliations

  • L.M. Giangregorio
    • 1
    • 2
    • 3
    Email author
  • J.C. Gibbs
    • 1
  • J.A. Templeton
    • 1
  • J.D. Adachi
    • 4
    • 5
  • M.C. Ashe
    • 6
    • 7
  • R.R. Bleakney
    • 8
  • A.M. Cheung
    • 8
  • K.D. Hill
    • 9
  • D.L. Kendler
    • 6
  • A. A. Khan
    • 4
  • S. Kim
    • 8
    • 10
  • C. McArthur
    • 1
    • 4
    • 11
  • N. Mittmann
    • 12
  • A. Papaioannou
    • 4
    • 11
  • S. Prasad
    • 4
  • S.C. Scherer
    • 13
    • 14
  • L. Thabane
    • 4
    • 5
  • J.D. Wark
    • 14
    • 15
  1. 1.Department of KinesiologyUniversity of WaterlooWaterlooCanada
  2. 2.Toronto Rehabilitation InstituteUniversity Health NetworkTorontoCanada
  3. 3.Schlegel-UW Research Institute for AgingWaterlooCanada
  4. 4.McMaster UniversityHamiltonCanada
  5. 5.St Joseph’s Healthcare—HamiltonHamiltonCanada
  6. 6.University of British ColumbiaVancouverCanada
  7. 7.Centre for Hip Health and MobilityVancouverCanada
  8. 8.University of TorontoTorontoCanada
  9. 9.School of Physiotherapy and Exercise Science, Faculty of Health SciencesCurtin UniversityPerthAustralia
  10. 10.Women’s College HospitalTorontoCanada
  11. 11.Geriatric Education and Research in Aging Sciences CentreHamiltonCanada
  12. 12.Sunnybrook Health Sciences CentreTorontoCanada
  13. 13.Broadmeadows Health ServiceBroadmeadowsAustralia
  14. 14.University of MelbourneMelbourneAustralia
  15. 15.Royal Melbourne HospitalParkvilleAustralia

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