Low Magnitude Mechanical Stimulation to Improve BMD

低强度机械刺激可改善 BMD

• 批准号: 8039339
• 负责人: DOUGLAS P. KIEL
• 金额: $ 62.36万
• 依托单位: HEBREW REHABILITATION CENTER FOR AGED
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8039339
• 关键词: Low; Magnitude; Mechanical; Stimulation; Improve

DESCRIPTION (provided by applicant): The prevention of fractures in the aged population is largely focused on pharmacologic interventions that inhibit bone resorption. The need for non-pharmacologic approaches to improve the musculoskeletal system as a whole and ultimately reduce the risk for fracture, forms the basis for this competing continuation of our ongoing randomized, double-blind, placebo-controlled trial of low magnitude mechanical stimulation (LMMS) called the "VIBES" trial. This trial, initiated in 2007 to study the skeletal effects of LMMS, has randomized 174 of the originally targeted 200 elderly participants with an adherence rate of 80%. In this continuation, we propose to extend the study intervention and follow up by one additional year, and to expand the scope of the science by considering a broader range of measures relevant to musculoskeletal health, including muscle area, density, and strength, as well as postural stability. This will also increase our power for the primary skeletal outcomes, which will be only 41% if the trial does not continue one additional year. The DSMB for the trial has recommended not unblinding any aspect of the current study, and is supportive of the extension to the VIBES trial. The overarching hypothesis of this clinical trial is that LMMS will have favorable effects on bone, muscle, and postural stability in a sample of independently living seniors. Thus the first aim of the project is to determine the skeletal effects of LMMS over a three year period by assessing serial quantitative computed tomography (QCT) measures of volumetric trabecular bone mineral density (vTBMB) of the hip and spine in the elderly subjects already enrolled in the original two-year study. During the trial we have developed novel methods of examining our QCT scans of the hip for muscle area and density, and have been collecting other measures not originally included in the trial, namely, muscle strength of the lower extremity, and postural stability using a balance platform. This provides data upon which the second aim is based. We hypothesize that LMMS will result in improved muscle area, density and strength, and will improve balance. The ongoing trial is well established in the senior communities, the study team has a successful track record, and there have been no safety concerns to date. Thus there is now a window of opportunity to continue the trial for an additional year and test multiple hypotheses surrounding this unique non-pharmacologic intervention. PUBLIC HEALTH RELEVANCE: The prevention of fractures in the aged population are largely focused on drug therapy to inhibit bone loss. This clinical trial of low magnitude mechanical stimulation (LMMS) in 174 elderly subjects residing in 16 retirement communities around Boston, MA (using 0.3g @ 30Hz, 10 min/d of LMMS) is intended to test a multidimensional, non-drug approach to improving the musculoskeletal system as a whole (bone, muscle, and balance). The significance of the study is that it will test the efficacy of this unique intervention to improve multiple components of the musculoskeletal system that contribute to fracture risk.

描述（由申请人提供）：老年人群骨折的预防主要集中在抑制骨吸收的药物干预上。需要非药理学方法来改善整个肌肉骨骼系统并最终降低骨折风险，这构成了我们正在进行的低强度机械刺激（LMMS）随机、双盲、安慰剂对照试验（称为“VIBES”试验）的竞争性延续的基础。这项试验于2007年开始，旨在研究LMMS对骨骼的影响，在最初的200名老年参与者中随机分配了174名，依从率为80%。在本延续研究中，我们建议将研究干预和随访延长一年，并通过考虑与肌肉骨骼健康相关的更广泛的指标（包括肌肉面积、密度和力量以及姿势稳定性）来扩大科学范围。这也将增加我们对主要骨骼结局的把握度，如果试验不再继续一年，这一把握度将仅为41%。本试验的DSMB建议不对当前研究的任何方面揭盲，并支持扩展至VIBES试验。这项临床试验的首要假设是，LMMS将对独立生活的老年人样本的骨骼、肌肉和姿势稳定性产生有利影响。因此，该项目的第一个目的是通过评估已入组原始两年研究的老年受试者髋关节和脊柱体积骨小梁矿物质密度（vTBMB）的系列定量计算机断层扫描（QCT）测量值，确定LMMS在三年内对骨骼的影响。在试验期间，我们开发了新的方法来检查我们的髋关节QCT扫描的肌肉面积和密度，并收集了最初未包括在试验中的其他指标，即下肢肌肉力量和使用平衡平台的姿势稳定性。这提供了第二个目标所依据的数据。我们假设LMMS将导致改善肌肉面积，密度和力量，并将改善平衡。正在进行的试验在老年人社区中得到了很好的建立，研究小组有着成功的记录，迄今为止没有安全性问题。因此，现在有机会继续试验一年，并测试围绕这种独特的非药物干预的多种假设。 公共卫生相关性：老年人群骨折的预防主要集中在抑制骨丢失的药物治疗上。这项低强度机械刺激（LMMS）的临床试验在居住在马萨诸塞州波士顿市周围16个退休社区的174名老年受试者中进行（使用0.3g@30Hz，10 min/d的LMMS），旨在测试一种改善整体肌肉骨骼系统（骨骼、肌肉和平衡）的多维、非药物方法。这项研究的意义在于，它将测试这种独特干预措施的有效性，以改善导致骨折风险的肌肉骨骼系统的多个组成部分。