Community Ambulation Following Hip Fracture

描述(申请人提供)：在社区内行走的能力对于开展日常活动至关重要；然而，50%的髋部骨折患者在骨折前独立行走，一年后需要辅助行走10英尺，许多能够在没有帮助的情况下行走的人移动得如此缓慢，以至于他们无法再行走被认为足以用于社区行走的距离。这项拟议的研究将评估从骨折后两个月开始的高强度、16周、多成分锻炼计划的能力，以提高患者在该计划启动后4个月步行社区步行距离的能力。在物理治疗师的直接监督下，将在患者居住地提供40次锻炼；锻炼将有针对性地提高耐力、平衡、肌肉力量和功能任务表现。这两组随机临床试验将确定在随机化后的4个月内，为期16周的训练计划是否可以提高患者在6分钟内步行300米的社区步行距离的能力。三个临床站点(巴尔的摩马里兰大学；阿卡迪亚大学；康涅狄格大学健康中心)将在住院后招募总共300名社区居住区髋部骨折患者(年龄65岁以上)，并随机分配给他们进行为期16周的高强度、有监督的家庭多成分锻炼计划或对照干预，包括伸展和活动范围锻炼以及低水平经皮电刺激。患者将在标准的急性后康复护理结束后(骨折后2个月)随机分组。两组患者都将接受补充维生素D3、钙、复合维生素和营养咨询，以促进体重稳定和充足的营养摄入。主要终点是随机化四个月后在6分钟内步行300米的能力。其他终点包括社区步行的前体(即耐力、平衡、肌肉表现和下肢功能)和选定的潜在机制(即肌肉内脂肪、股四头肌容量、循环炎症细胞因子和VO2峰值)。还将对成本效益进行评估。这项研究的目的是检测锻炼组和对照组之间在90%功率(阿尔法=.05)意向处理分析。结果将有助于更好地理解创新的髋部骨折后物理治疗的动力学。研究结果的影响将直接与髋部骨折患者在社区独立行走的能力和拟议干预措施的成本效益有关。 与公共健康相关：美国每年发生超过325,000例髋部骨折，相关的医疗费用估计为140-200亿美元。目前临床实践的目标是术后2-3个月独立、安全的家庭步行，但髋部骨折获得性依赖仍持续3个月以上。这项研究将评估一项为患者提供的为期16周的多成分锻炼计划，以确定其是否有效地提高在社区中独立行走的能力(即社区步行)。

DESCRIPTION (provided by applicant): The ability to ambulate in the community is of critical importance for carrying out daily activities; yet 50% of hip fracture patients who walked independently before a fracture require assistance to walk 10 feet a year later, and many of those that are able to walk without assistance move so slowly that they are no longer able to walk a distance considered adequate for community ambulation. The proposed study will evaluate the ability of a high intensity, 16-week, multi-component exercise program beginning two months post-fracture to improve patients' ability to walk a community ambulation distance at 4 months post-initiation of the program. Forty exercise sessions will be provided in patients' place of residence under the direct supervision of physical therapists; exercises will be targeted to improve endurance, balance, muscle strength, and functional task performance. This two group randomized clinical trial will determine if a 16-week training program can improve patients' ability to walk a community ambulation distance of 300 meters in six minutes at 4 months following randomization. Three clinical sites (University of Maryland Baltimore; Arcadia University; University of Connecticut Health Center) will recruit a total of 300 community dwelling hip fracture patients (aged 65+) following hospitalization, and randomly assign them to a 16-week high intensity, supervised, home delivered multi-component exercise program or a control intervention consisting of stretching and range of motion exercises, and low level transcutaneous electrical stimulation. Patients will be randomized after standard post- acute rehabilitative care ends (2 months post-fracture). Patients in both groups will receive supplemental vitamin D3, calcium, a multivitamin and nutritional counseling to promote weight stability and adequate nutrient intake. The primary endpoint is the ability to walk 300 meters in 6 minutes four months post randomization. Other endpoints include precursors (i.e., endurance, balance, muscle performance, and lower extremity function) and selected underlying mechanisms (i.e., intra-muscular fat, quadriceps volume, circulating inflammatory cytokines, and VO2 peak) to community ambulation. Cost effectiveness also will be evaluated. The study is designed to detect at least a 20 percentage point difference between the exercise and control groups in the primary outcome with 90 percent power (alpha=. 05) in an intention to treat analysis. Results will lead to a better understanding of the dynamics of innovative post hip fracture physical therapy. Implications of study findings will relate directly to hip fracture patients' ability to ambulate independently in the community and the cost-effectiveness of the proposed intervention. PUBLIC HEALTH RELEVANCE: More than 325,000 hip fractures occur annually in the US, with associated health care costs estimated at $14-20 billion. The goal of current clinical practice is independent, safe household ambulation, at 2-3 months post surgery, yet hip fracture-acquired dependency persists well beyond three months. This study will evaluate a 16-week multi-component exercise program provided to patients in their homes to determine if it is effective in improving the ability to walk independently in the community (i.e., community ambulation).