A WEIGHTED VEST TO PREVENT LEG WEAKNESS AND OSTEOPOROSIS

减轻腿部无力和骨质疏松症的加重背心

• 批准号: 6312682
• 负责人: GAIL A GREENDALE
• 金额: $ 9.71万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-01 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6312682
• 关键词: balance; biomechanics; biomedical equipment safety; body composition; body height; body weight; bone density; bone metabolism; calcium metabolism; clinical research; clinical trials; disease /disorder prevention /control; functional ability; gait; health behavior; health care service utilization; hip; human old age (65+); human subject; longitudinal human study; muscle strength; osteocalcin; osteoporosis; performance

This project will consist of a 2-year intervention development study (IDS) followed by a 3-year intervention study (IS). The overall objective of the project is to test whether wearing a weighted vest can prevent muscular weakness and osteoporosis. First, an IDS will be conducted to further refine the vest dose and to assess whether biomechanical approximations of bone loading by vest use can be measured. Second, a randomized controlled trial will be conducted to test the effect of the vest on muscular strength and bone mineral density. The nylon vest can be weighted to a maximum of 12 kg and is prescribed as a percent of body weight (%BW). Subjects wear the vest during routine daily activities (eg, chores, walks) for 2 hours per day, 4 days per week. No additional specific physical activity prescription is required. The IDS will consist of a 27-week, 3-armed (control, 3%BW, 5%BW) pre-post study in 60 subjects to compare the effects of these doses on knee extensor strength, side-effects, and adherence. Prior vest studies suggest that 5%BW is the maximum tolerated in this population; thus, maximum and 1/2 maximum dose are selected for the IS. The dose for the RCT will be decided based on the effect of each on: knee extensor strength; safety; and adherence. The IDS will evaluate whether proposed biomechanical measures of hip loading, hip joint reaction forces and hip moments-of-force, change with vest use. The effects of each vest dose on: 1) bone turnover indicators; 2) gait and balance; 3) self-reported functional status and observed physical performance will be assessed. Adherence to vest use 3 and 6 months after the termination of the intervention will also be examined. The IS will consist of a 24-month, single blinded, two armed randomized controlled trial in 66 subjects. It will examine the effects of one dose of the vest (determined by the IDS) compared to an attention control group on the following: 1) total hip BMD; 2) amount and time course of change in isokinetic knee extensor strength; and 3) long-term safety of and adherence to vest use. If the IDS has been successful in quantifying the postulated biomechanical measures of hip loading, a fourth primary objective of the RCT will be to assess the ability of the biomechanical measures to predict changes in BMD, to explore the mechanism by which the vest accomplishes bone tropism. The secondary RCT objectives include measurement of the effect of vest use on: spinal BMD; total body calcium; body composition; bone turnover markers; gait and balance; functional status; and physical performance.

该项目将包括为期 2 年的干预开发研究 (IDS) 随后进行为期 3 年的干预研究 (IS)。 整体 该项目的目的是测试穿着加重背心是否可以 预防肌肉无力和骨质疏松症。 首先，IDS 将是 进行进一步细化背心剂量并评估是否 可以测量背心使用的骨负荷的生物力学近似值。 其次，将进行随机对照试验来测试 背心对肌肉力量和骨矿物质密度的影响。 尼龙背心最大重量为 12 公斤，并规定 占体重的百分比 (%BW)。 受试者在日常活动中穿着背心 每天 2 小时的日常活动（例如，做家务、散步），每天 4 天 星期。 不需要额外的具体身体活动处方。 IDS 将包括为期 27 周的 3 组（对照、3%BW、5%BW）预后期 对 60 名受试者进行的研究，比较这些剂量对膝盖的影响 伸肌力量、副作用和依从性。 先前的背心研究 建议 5%BW 是该人群的最大耐受量；因此， IS 选择最大剂量和 1/2 最大剂量。 剂量为 RCT 将根据以下各项的效果来决定： 膝关节伸肌 力量;安全;和坚持。 IDS 将评估所提出的髋关节生物力学测量是否 载荷、髋关节反作用力和髋关节力矩，随着变化 背心使用。 每个背心剂量对以下方面的影响：1) 骨转换 指标； 2）步态和平衡； 3）自我报告的功能状态和 将评估观察到的身体表现。 遵守背心使用 干预结束后 3 个月和 6 个月也将 检查了。 IS 将包括为期 24 个月、单盲、两名武装随机 66 名受试者的对照试验。 它将检查一剂剂量的效果 背心（由 IDS 确定）与注意力控制相比 分组如下：1）总髋部 BMD； 2) 数量和时间过程 等速伸膝肌力的变化； 3）长期安全性 并坚持使用背心。 如果 IDS 已成功 量化髋部负荷的假设生物力学测量， RCT 的第四个主要目标是评估 预测 BMD 变化的生物力学措施，探索 背心实现骨向性的机制。 次要 RCT 目标包括衡量背心的效果 用于：脊柱 BMD；全身钙；身体成分；骨转换 标记；步态和平衡；功能状态；和身体表现。