Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.
Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.
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DOI：
10.1177/1740774510371014
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发表时间：
2010-08
期刊：
影响因子：
--
通讯作者：
Rubin CT
中科院分区：
文献类型：
--
作者：
Kiel DP;Hannan MT;Barton BA;Bouxsein ML;Lang TF;Brown KM;Shane E;Magaziner J;Zimmerman S;Rubin CT
骨质疏松症是衰老的常见并发症。老年人需要药物治疗的替代方案。动物和人类研究表明，采用低强度、高频机械刺激的非药物治疗可以预防骨质流失。 VIBES（振动改善老年受试者骨密度）研究是一项随机、双盲、假对照试验，研究对象为 200 名 60 岁及以上的男性和女性，研究低强度、高频机械刺激的功效，入组时双 X 射线骨密度测定的骨矿物质密度 T 分数在 –1 至 –2.5 之间。参与者是波士顿地区独立生活社区的健康、认知能力完整的居民，他们接受免费的钙和维生素 D 补充剂。他们被随机分配接受主动治疗或假治疗，并每天在指定的平台上站立一次 10 分钟。所有平台都具有可下载到笔记本电脑的依从性数据收集软件。不良事件受到密切监测。 174 名参与者被随机分组，并将接受为期两年的随访。几乎所有活跃受试者都获得了一年的随访。骨矿物质密度通过双 X 射线吸收测定法和定量计算机断层扫描在基线和每年进行测量。主要分析将通过定量计算机断层扫描来比较活动组和假组中体积骨密度相对于基线的平均变化。还将评估依从性和治疗效果的大小。二次分析将比较骨转换的三种生化标志物的变化以及肌肉和平衡终点的纵向比较。 VIBES 试验已经完成了第一年的数据收集，并遇到了多项挑战，从而获得了宝贵的经验教训，包括从独立生活社区招募人员、使用射频识别卡和电子依从性监测部署多用户机械设备、在中心站点组织成像运输以及扩大研究范围以纳入其他肌肉骨骼结果。这些教训将指导未来对高龄个体的研究。
Osteoporosis is a common complication of aging. Alternatives to pharmacologic treatment are needed for older adults. Non-pharmacologic treatment with low magnitude, high frequency mechanical stimulation has been shown to prevent bone loss in animal and human studies. The VIBES (Vibration to Improve Bone Density in Elderly Subjects) study is a randomized, double-blind, sham-controlled trial of the efficacy of low magnitude, high frequency mechanical stimulation in 200 men and women aged 60 years and older with bone mineral density T-scores by dual-x-ray absorptiometry between –1 and –2.5 at entry. Participants are healthy, cognitively intact residents of independent living communities in the Boston area who receive free calcium and Vitamin D supplements. They are randomly assigned to active or sham treatment and stand on their assigned platform once daily for 10 minutes. All platforms have adherence data collection software downloadable to a laptop computer. Adverse events are closely monitored. 174 participants were randomized and will be followed for two years. Almost all active subjects have attained one year of follow-up. Bone mineral density is measured by both dual x-ray absorptiometry and quantitative computed tomography at baseline and annually. The main analysis will compare mean changes from baseline in volumetric bone density by quantitative computed tomography in active and sham groups. Adherence and treatment effect magnitude will also be evaluated. Secondary analyses will compare changes in three biochemical markers of bone turnover as well as longitudinal comparisons of muscle and balance endpoints. The VIBES trial has completed its first year of data collection and encountered multiple challenges leading to valuable lessons learned about the areas of recruitment from independent living communities, deployment of multi-user mechanical devices using radio frequency identification cards and electronic adherence monitoring, organization of transportation for imaging at a central site, and the expansion of study aims to include additional musculoskeletal outcomes. These lessons will guide future investigations in studies of individuals of advanced age.
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影响因子：
4
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