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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

  • L.M. Giangregorio
  • 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

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.

Keywords

Aged Exercise Feasibility Female Osteoporosis RCT 

Notes

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.

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

None.

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Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2018

Authors and Affiliations

  • L.M. Giangregorio
    • 1
    • 2
    • 3
  • 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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