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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

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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.

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Acknowledgements

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.

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Authors and Affiliations

  1. Department of Kinesiology, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada

    L.M. Giangregorio, J.C. Gibbs, J.A. Templeton & C. McArthur

  2. Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada

    L.M. Giangregorio

  3. Schlegel-UW Research Institute for Aging, Waterloo, Ontario, Canada

    L.M. Giangregorio

  4. McMaster University, Hamilton, Ontario, Canada

    J.D. Adachi, A. A. Khan, C. McArthur, A. Papaioannou, S. Prasad & L. Thabane

  5. St Joseph’s Healthcare—Hamilton, Hamilton, Ontario, Canada

    J.D. Adachi & L. Thabane

  6. University of British Columbia, Vancouver, Canada

    M.C. Ashe & D.L. Kendler

  7. Centre for Hip Health and Mobility, Vancouver, Canada

    M.C. Ashe

  8. University of Toronto, Toronto, Ontario, Canada

    R.R. Bleakney, A.M. Cheung & S. Kim

  9. School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Australia

    K.D. Hill

  10. Women’s College Hospital, Toronto, Ontario, Canada

    S. Kim

  11. Geriatric Education and Research in Aging Sciences Centre, Hamilton, Ontario, Canada

    C. McArthur & A. Papaioannou

  12. Sunnybrook Health Sciences Centre, Toronto, Canada

    N. Mittmann

  13. Broadmeadows Health Service, Broadmeadows, Australia

    S.C. Scherer

  14. University of Melbourne, Melbourne, Australia

    S.C. Scherer & J.D. Wark

  15. Royal Melbourne Hospital, Parkville, Australia

    J.D. Wark

Authors
  1. L.M. Giangregorio
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  2. J.C. Gibbs
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  3. J.A. Templeton
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  4. J.D. Adachi
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  5. M.C. Ashe
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  6. R.R. Bleakney
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  7. A.M. Cheung
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  8. K.D. Hill
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  9. D.L. Kendler
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  10. A. A. Khan
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  11. S. Kim
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  12. C. McArthur
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  13. N. Mittmann
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  14. A. Papaioannou
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  15. S. Prasad
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  16. S.C. Scherer
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  17. L. Thabane
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  18. J.D. Wark
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Corresponding author

Correspondence to L.M. Giangregorio.

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

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Giangregorio, L., Gibbs, J., Templeton, J. et al. 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. Osteoporos Int 29, 2545–2556 (2018). https://doi.org/10.1007/s00198-018-4652-0

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