Establishing the compliance in elderly women for use of a low level mechanical stress device in a clinical osteoporosis study
Establishing the compliance in elderly women for use of a low level mechanical stress device in a clinical osteoporosis study
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DOI：
10.1007/s00198-004-1637-y
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发表时间：
2004-11-01
影响因子：
4
通讯作者：
Kiel, DP
中科院分区：
文献类型：
--
作者：
Hannan, MT;Cheng, DM;Kiel, DP
预防骨质流失的非药物方法非常适合老年患者，以避免多种药物和药物副作用。一种潜在的治疗方法是振动平台，其提供低水平的机械负荷，刺激骨重建。然而，依从性是任何日常治疗的一个主要问题，对于使用该设备的老年群体来说，这是未知的。因此，我们评估了老年妇女（骨质疏松症治疗的目标人群）在振动平台设备上站立10分钟/天的依从性。我们还评估了日常使用器械的满意度。我们进行了一项随机、安慰剂对照、双盲、为期6个月的研究，在持续护理退休社区的老年妇女中每天使用10分钟的振动平台治疗。每例受试者的依从性计算为6个月试验中参加的天数除以182天。24名老年女性（平均年龄86岁，范围79-92岁）在6个月内每日治疗的依从性为83%（95% CI：70.5，94.5）。排除3名研究脱落者，21名女性的依从性为93%（95% CI：89.8，95.6），活性药物和安慰剂治疗的依从性无差异。6个月内缺失治疗天数的主要原因是假期（54%的缺失天数）和疾病（29%）。发生了3起不良事件; 1起（晕厥）可能与器械使用有关，而另外2起与器械使用无关。在参与者中，95%的人对振动平台的日常使用表示总体满意，57%的人更喜欢平台而不是每日口服药物来预防骨质流失。老年妇女表现出高依从性，高满意度和不良反应的经验很少与每日非药物治疗，旨在抑制骨丢失。大型随机对照试验应评价振动平台器械治疗老年人低骨量和骨质疏松症的长期疗效。
Non-pharmacologic approaches to prevent bone loss are well suited for elderly patients to avoid polypharmacy and medication side effects. One potential treatment is a vibrating platform that delivers low-level mechanical loading stimulating bone remodeling. However, compliance is a major concern with any daily treatment, and is unknown for an elderly group using this device. Thus we assessed compliance with standing 10 min/day on a vibrating platform device in elderly women, the target population for osteoporosis therapy. We also assessed satisfaction with daily use of the device. We conducted a randomized, placebo-controlled, double-blinded 6-month study for daily use of a 10-min vibrating platform treatment in elderly women who were residents of a Continuing Care Retirement community. Compliance for each subject was calculated as the number of days attended divided by the 182 days in the 6-month trial. The 24 elderly women (mean age 86, range 79-92 years) had 83% compliance (95% CI: 70.5, 94.5) for daily treatment over 6 months. Excluding three study drop-outs, the 21 women had 93% compliance (95% CI: 89.8, 95.6), with no difference in compliance between active and placebo treatment. Main reasons for missing treatment days over the 6 months were vacation (54% of missed days) and illness (29%). Three adverse events occurred; one (syncope) was possibly related to device use, whereas the other two were not related to device use. Among participants, 95% reported overall satisfaction with daily use of the vibrating platform, and 57% preferred the platform versus daily oral medications for prevention of bone loss. Elderly women showed high compliance, high satisfaction and few adverse experiences with a daily non-pharmacological treatment designed to inhibit bone loss. Larger randomized controlled trials should evaluate the long-term efficacy of vibrating platform devices for treatment of low bone mass and osteoporosis in elderly individuals.