Effects of Multi-Modal Exercise Intervention Post Hip Fracture

这项拟议的优点扩展将继续 1983 年启动的一系列研究，该研究已发展成为一项 国际认可的项目巴尔的摩髋关节研究 (BHS) 致力于识别、开发、 并评估优化髋部骨折后恢复的策略。这个优点扩展有两个 组件，将扩展先前优异奖研究和其他 BHS 项目的发现，证明 髋部骨折导致肌肉、脂肪量和肌肉强度、骨密度和强度发生巨大变化， 骨转换标志物、激素和炎症标志物的血清水平，以及行走能力和 其他方面的功能。目标是：1）研究实现这一目标的一些关键机制。 社区活动因多模式运动干预（MMEI）而发生的变化 这个体弱和残疾的老年人群体（第一部分）； 2）通过初步方式进行测试 对不同患者样本进行的试点/可行性研究，添加蛋白质补充剂的额外好处 进行 MMEI 治疗后，确定骨骼、肌肉、炎症和身体状况是否发生重要变化 功能（组件 II）。 MMEI，正在最近资助的 III 期随机临床试验中进行测试 (1R01AG035009) 是一个以家庭为基础的计划，针对三个中心的 300 名患者进行治疗，旨在解决以下问题： 通过 40 次监督课程来提高耐力、力量、平衡和功能。其主要成果是 RCT 是指在社区中独立行走的能力。 本优点扩展的第一部分将作为 III 期 RCT 的辅助研究进行，添加 对马里兰州巴尔的摩临床中心招募的患者进行机械论测量（最低 报名人数 = 60；每组30个）。第二部分将招募 30 名额外患者并提供乳清 完成每个 MMEI 课程后立即补充蛋白质和氨基酸 检查额外的机械效益和可行性。这两个部分的参与者都将事先接受评估 进行随机分组（因髋部骨折住院后 2 个月内），并在 4 个月和 10 个月后再次进行随机分组 以检查干预措施的直接效果（主要结果）和持续效益。 我们还将与国际专家组合作，确定加速发展和发展的战略。 对这组经历过这种突然致残事件的老年人进行干预测试。

This proposed Merit Extension will continue a line of research initiated In 1983 that has evolved into an internationally recognized program, the Baltimore Hip Studies (BHS), dedicated to identifying, developing, and evaluating strategies to optimize recovery following hip fracture. This Merit Extension, which has two components, will extend findings from prior Merit Award studies and other BHS projects demonstrating that hip fracture results In dramatic changes in muscle, fat mass and muscle strength, bone density and strength, bone turnover markers, serum levels of hormones and inflammatory markers, as well as walking ability and other aspects of function. The goals are to: 1) study some of the key mechanisms on the pathway to changes in community ambulation in response to a Multi-modal Exercise Intervention (MMEI) delivered to this frail and disabled group of older persons (Component I); and 2) test, in a preliminary manner through a pilot/feasibility study of a different sample of patients, the additional benefit of adding a protein supplement following MMEI sessions to determine if there are important changes in bone, muscle, inflammation, and function (Component II). The MMEI, being tested in a recently funded Phase III randomized clinical trial (1R01AG035009) of 300 patients In three centers, is a home-based program that addresses deficits in endurance, strength, balance and function through 40 supervised sessions. The primary outcome of that RCT is the ability to ambulate independently in the community. Component I of this Merit Extension will be conducted as an ancillary study to the Phase III RCT by adding mectianistic measurements to the patients recruited in the Baltimore, Maryland clinical site (Minimum number enrolled = 60; 30 per group). Component II wiil recruit 30 additional patients and provide a whey based protein and amino acid supplement immediately after completing each ofthe MMEI sessions to examine added mechanistic benefits and feasibility. Participants in both components will be assessed prior to randomization (within 2 months post hospitalization for hip fracture), and again 4 and 10 months later in order to examine the immediate effects (primary outcome) and the sustained benefits of interventions. We also will work with an international group of experts to identify strategies to accelerate development and testing of interventions for this group of older persons who experience this sudden disabling event.