Community Ambulation Following Hip Fracture

描述（由申请人提供）：在社区中行走的能力对于开展日常活动至关重要;然而，50%在骨折前独立行走的髋部骨折患者在一年后需要辅助行走10英尺，并且许多能够在没有辅助的情况下行走的患者移动得如此缓慢，以至于他们不再能够行走足够的距离。这项拟议的研究将评估骨折后两个月开始的高强度、16周、多成分运动计划的能力，以提高患者在计划开始后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，将在患者的居住地提供40次锻炼;锻炼的目标是提高耐力、平衡、肌肉力量和功能性任务表现。 这项两组随机临床试验将确定16周的训练计划是否可以提高患者在随机分组后4个月内在6分钟内步行300米社区步行距离的能力。3个临床研究中心（马里兰州巴尔的摩大学;阿卡迪亚大学;康涅狄格大学健康中心）将招募共计300名社区居住的髋部骨折患者（65岁以上），并随机分配他们接受为期16周的高强度、监督、家庭交付的多组分运动计划或由拉伸和运动范围组成的对照干预，和低水平经皮电刺激。患者将在标准急性期后康复护理结束后（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、多种维生素和营养咨询，以促进体重稳定和充足的营养摄入。主要终点是随机化后4个月在6分钟内步行300米的能力。其他终点包括前体（即，耐力、平衡、肌肉性能和下肢功能）和选定的潜在机制（即，肌内脂肪、股四头肌体积、循环炎性细胞因子和VO 2峰值）与社区活动的关系。还将评估成本效益。该研究旨在检测运动组和对照组之间在主要结果方面至少有20个百分点的差异，具有90%的功效（α = 0. 05)意图治疗分析。结果将导致更好地了解创新髋部骨折后物理治疗的动态。研究结果的意义将直接关系到髋部骨折患者在社区中独立行走的能力和拟议干预的成本效益。

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.