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
MetadataShow full item record
© 2018, International Osteoporosis Foundation and National Osteoporosis Foundation. 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.
Showing items related by title, author, creator and subject.
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 fractureGiangregorio, L.; Thabane, L.; Adachi, J.; Ashe, M.; Bleakney, R.; Braun, E.; Cheung, A.; Fraser, L.; Gibbs, J.; Hill, Keith; Hodsman, A.; Kendler, D.; Mittmann, N.; Prasad, S.; Scherer, S.; Wark, J.; Papaioannou, A. (2014)Background - Our goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ≥65 years with a vertebral ...
Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): A feasibility study protocolSkelton, D.; Bailey, C.; Howel, D.; Cattan, M.; Deary, V.; Coe, D.; De Jong, Lex; Gawler, S.; Gray, J.; Lampitt, R.; Wilkinson, J.; Adams, N. (2016)Introduction In the UK, 1 in 5 people aged 75 and over live with sight loss. Visually impaired older people (VIOP) have an above average incidence of falls and 1.3-1.9 times more likely to experience hip fractures, than ...
Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: The VIOLET studyAdams, N.; Skelton, D.; Howel, D.; Bailey, C.; Lampitt, R.; Fouweather, T.; Gray, J.; Coe, D.; Wilkinson, J.; Gawler, S.; De Jong, Lex; Waterman, H.; Deary, V.; Clarke, M.; Parry, S. (2018)Background: Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) ...