Effects of Multi-Modal Exercise Intervention Post Hip Fracture

髋部骨折后多模式运动干预的效果

• 批准号: 8530123
• 负责人: JAY MAGAZINER
• 金额: $ 97.59万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8530123
• 关键词: Address; Aerobic; Affect; Amino Acids; Ancillary Study; Award; Baltimore; Bone Density; Bone Resorption; Cognition; Communities; Control Groups; Dependency; Development; Disabled Persons; Elderly; Enrollment; Equilibrium; Essential Amino Acids; Estradiol; Event; Exercise; Fatty acid glycerol esters; Feasibility Studies; Funding; Gait; Goals; Hip Fractures; Hip region structure; Home environment; Hormones; Hospitalization; Household; Inflammation; Instruction; Insulin-Like Growth Factor I; International; Intervention; Intervention Studies; Lower Extremity; Maryland; Measurement; Measures; Mediating; Muscle; Operative Surgical Procedures; Participant; Pathway interactions; Patients; Performance; Phase; Pilot Projects; Proteins; Randomized; Randomized Clinical Trials; Recovery; Recruitment Activity; Research; Safety; Sample Size; Sampling; Serum Markers; Site; Supplementation; Testing; Testosterone; Thigh structure; Walking; Work; attenuation; base; bone; bone strength; bone turnover; clinical research site; cytokine; depressive symptoms; effective intervention; experience; group intervention; inflammatory marker; intervention effect; member; muscle strength; post intervention; primary outcome; programs; response

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.

这一拟议中的优点扩展将继续1983年开始的一系列研究，该研究已经发展成为一个 国际公认的计划，巴尔的摩髋关节研究（BHS），致力于确定，发展， 评估策略以优化髋部骨折后的恢复。这个优点扩展，其中有两个 组件，将扩展之前的优异奖研究和其他BHS项目的发现， 髋部骨折导致肌肉、脂肪量和肌肉强度、骨密度和强度的显著变化， 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 功能的其他方面。其目标是：1）研究途径上的一些关键机制， 社区卫生服务的变化，以应对多模式运动干预（MMEI）提供给 这一脆弱和残疾的老年人群体（第一部分）;和2）通过一项初步测试， 不同患者样本的试点/可行性研究，添加蛋白质补充剂的额外益处 在MMEI疗程后，确定骨骼、肌肉、炎症和 职能（第二部分）。MMEI正在最近资助的III期随机临床试验中进行测试 （1 R 01 AG 035009）的300名患者在三个中心，是一个家庭为基础的计划，解决赤字， 耐力，力量，平衡和功能通过40监督会议.主要结果是， RCT是指在社区中独立行走的能力。 本Merit扩展研究的第I部分将作为III期RCT的辅助研究进行， 对巴尔的摩，马里兰州临床研究中心招募的患者进行机械测量（最小值 入组人数= 60;每组30人）。第二部分将招募30名额外的患者， 在完成每个MMEI疗程后立即补充蛋白质和氨基酸， 研究增加的机械效益和可行性。两个部分的参与者将在 随机分组（髋部骨折住院后2个月内），4个月和10个月后再次随机分组， 为了检查干预措施的直接效果（主要成果）和持续效益。 我们还将与一个国际专家组合作，确定加快发展的战略， 测试对这类突然致残的老年人的干预措施。