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
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.
KeywordsAged 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.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 CrossRefPubMedPubMedCentralGoogle Scholar
- 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. https://doi.org/10.1503/cmaj.081720 CrossRefPubMedPubMedCentralGoogle Scholar
- 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. https://doi.org/10.7326/0003-4819-148-3-200802050-00198 CrossRefPubMedGoogle Scholar
- 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. https://doi.org/10.1359/JBMR.041003 CrossRefPubMedGoogle Scholar
- 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.Gibbs JC, MacIntyre NJ, Templeton JA et al. Exercise for improving outcomes after osteoporotic vertebral fracture. Cochrane Database Syst RevGoogle Scholar
- 11.Moayyeri A (2008) The association between physical activity and osteoporotic fractures: a review of the evidence and implications for future researchGoogle Scholar
- 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
- 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 CrossRefPubMedGoogle Scholar
- 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 CrossRefPubMedGoogle Scholar
- 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 CrossRefPubMedGoogle Scholar
- 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 PubMedPubMedCentralCrossRefGoogle Scholar
- 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 CrossRefPubMedPubMedCentralGoogle Scholar
- 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 CrossRefPubMedPubMedCentralGoogle Scholar
- 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–M94CrossRefPubMedGoogle Scholar
- 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.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 CrossRefPubMedGoogle Scholar
- 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.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 CrossRefPubMedPubMedCentralGoogle Scholar
- 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 CrossRefPubMedGoogle Scholar