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举手计划:一项针对 50-65 岁桡骨远端骨折后成年人的骨健康运动和教育方案的随机对照试验的可行性研究结果。

Hands Up Program: Results of a feasibility study of a randomized controlled trial of a bone health exercise and education program for adults aged 50-65 post distal radius fracture.

机构信息

School of Physical Therapy, Department of Health and rehabilitation Sciences, University of Western Ontario, London, Ontario, Canada.

Clinical Research Lab, Roth McFarlane Hand and Upper Limb Centre, St. Joseph's Health Centre, London, Ontario, Canada.

出版信息

PLoS One. 2024 Nov 5;19(11):e0313013. doi: 10.1371/journal.pone.0313013. eCollection 2024.

Abstract

PURPOSE

Distal radius fractures (DRF) that occur from a fall from level ground are considered fragility fractures and may be the first indication that someone has compromised bone mineral density and is at risk of having osteoporosis. Women at about 50 years of age experience a dramatic increase risk of these fractures. Rehabilitation after DRF focuses on restoring range of motion and strength in the wrist, but rarely address future bone health concerns. We developed a 6-week therapist-developed remote full body exercise and osteoporosis/bone-health education program (called The Hands Up Program). This study was designed to evaluate the feasibility of a larger trial examining the effects of a whole-body exercise and education program for people 50-65 after a DRF.

METHODS

Community dwelling individuals between the age of 50-65 with a radiographically confirmed DRF were recruited from the Roth| McFarlane Hand and Upper Limb Center in London, Ontario. Participants were randomized in a 1:1 ratio into either the Hands Up Program which was a twice weekly exercise and education program for 6 weeks, or the control group where they proceeded with usual care. The intervention was delivered online through a website where participants created a unique username and password to access. The primary feasibility outcomes of the study were recruitment rate (74 participants in 1 year), retention rate (75% completion), and intervention adherence rate (60% of completion of the exercise program). Secondary outcomes included strength, range of motion, self-reported outcomes, and bone density.

RESULTS

Overall, 74 participants were recruited in 14 months. Retention did not meet the criteria for success, as only 53% of the participants attended their 12-month visit. Adherence was also not met albeit close with 55% completing the exercise program. Twelve participants withdrew from the study, five due to the time commitment, four without explanation, one due to group allocation, one due to COVID and one participant moved. One participant was deemed ineligible after consent. Four of the participants that withdrew were in the intervention group, and four in the control group, five participants withdrew before they were allocated to a group. Feedback from patients indicated potential improvements to the program: lower assessment burden, spacing out the intervention so that the education portion could be delivered during the immobilization phase of recovery, and creating a more individualized program.

CONCLUSION

Adherence and retention were both a challenge, although adherence was close to target. While achieving adherence to exercise in bone health is a known challenge, given the importance of prevention in the at-risk DRF population and the challenges in co-design and delivery during the pandemic, we believe evaluation of a revitalized program is warranted.

摘要

目的

从平地跌倒引起的桡骨远端骨折(DRF)被认为是脆性骨折,可能是表明某人骨密度受损且有骨质疏松症风险的第一个迹象。大约 50 岁的女性发生这些骨折的风险急剧增加。DRF 后的康复重点是恢复手腕的活动范围和力量,但很少关注未来的骨骼健康问题。我们开发了一个为期 6 周的治疗师开发的远程全身运动和骨质疏松症/骨骼健康教育计划(称为“举手计划”)。这项研究旨在评估更大规模试验的可行性,该试验检查了针对 DRF 后 50-65 岁人群的全身运动和教育计划的效果。

方法

从安大略省伦敦的 Roth|McFarlane 手部和上肢中心招募了年龄在 50-65 岁之间、经影像学证实患有 DRF 的社区居民。参与者以 1:1 的比例随机分为“举手计划”组(每周两次的锻炼和教育计划,持续 6 周)或对照组,对照组继续接受常规护理。干预措施通过一个网站在线提供,参与者创建一个独特的用户名和密码来访问该网站。该研究的主要可行性结果是招募率(1 年内 74 名参与者)、保留率(75%完成)和干预依从率(完成锻炼计划的 60%)。次要结果包括力量、活动范围、自我报告结果和骨密度。

结果

总体而言,在 14 个月内招募了 74 名参与者。保留率未达到成功标准,因为只有 53%的参与者参加了 12 个月的随访。尽管接近目标,但依从性也未达到,只有 55%的人完成了锻炼计划。12 名参与者退出了研究,5 名因时间承诺,4 名无解释,1 名因分组,1 名因 COVID,1 名参与者搬家。一名参与者在同意后被认为不合格。退出的 4 名参与者在干预组,4 名在对照组,5 名参与者在分组前退出。患者的反馈表明该计划可能需要改进:降低评估负担、分散干预措施,以便在康复的固定阶段可以提供教育部分,并创建更个性化的计划。

结论

尽管依从性接近目标,但依从性和保留率都面临挑战。虽然在骨骼健康方面进行锻炼的依从性是一个已知的挑战,但鉴于在易患 DRF 的人群中预防的重要性,以及在大流行期间共同设计和提供服务的挑战,我们认为有必要评估该计划的复兴。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56f2/11537389/b7542f7bcb09/pone.0313013.g001.jpg

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