Department of Kinesiology, University of Waterloo, 200 University Avenue West, Waterloo, ON, N2L 3G1, Canada.
Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.
Osteoporos Int. 2018 Nov;29(11):2545-2556. doi: 10.1007/s00198-018-4652-0. Epub 2018 Aug 8.
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.
我们对患有骨质疏松症和脊柱骨折的个体进行了家庭运动试验。虽然比预期的时间长，但我们达到了目标入组人数。参与者留在研究中并完成了运动计划，没有出现安全问题。未来的试验应该扩大纳入标准，并考虑其他变化。
骨质疏松性脆性骨折给人类和经济带来了巨大负担。有人呼吁进行一项大型随机对照试验，以检验运动对骨折发生率的影响。B3E 试验旨在评估一项大型试验的可行性，该试验研究家庭运动对骨折高危个体的影响。
在加拿大和澳大利亚的七个地点招募了社区居住的年龄≥65 岁、有影像学证实的椎体压缩性骨折的女性。我们以 1:1 的比例将参与者随机分为 12 个月的家庭运动计划组或同等关注对照组，均由物理治疗师（PT）提供。除了每月由 PT 和一位盲法研究助理打电话外，参与者还接受了六次 PT 家访。该研究的主要可行性结果是入组率（1 年内每个地点 20 人）、保留率（完成率 75%）和干预依从率（达到运动目标的周数 60%）。次要结果包括跌倒、骨折和不良事件。
共招募了 141 名参与者；平均每个地点 20 人，但大多数地点的入组时间都比预期的长。保留率和依从性达到了成功的标准：92%的参与者完成了研究；平均依从率为 66%。与对照组相比，干预组的跌倒次数（IRR 0.97，95%CI 0.58 至 1.63）或脆性骨折（OR 1.11，95%CI 0.60 至 2.05）差异无统计学意义。干预组有 18 例严重不良事件，对照组有 12 例。
女性椎体骨折家庭运动的 RCT 是可行的，但招募是一个挑战。对未来试验提出了建议。
