Sadruddin Pidani Anum, Sabzwari Saniya, Ahmad Khabir, Mohammed Ata, Noordin Shahryar
Department of Surgery, Aga Khan University, Karachi, Pakistan.
Department of Family Medicine, Aga Khan University, Karachi, Pakistan.
Int J Surg Protoc. 2020 Jun 18;22:24-28. doi: 10.1016/j.isjp.2020.06.002. eCollection 2020.
Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. In particular ongoing exercise which targets balance can prevent up to 40% of falls. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.
The study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge. The Primary outcome of the study is occurrence of falls. Falls will be measured at 3, 6, 12, and 24 months by research-assistant follow-up telephone calls for both the groups. Mobility-related disability will be measured with a self-reported test at every routine follow-up for up to two years using a performance-based short battery tool. Negative binomial regression model will be used to compare number of falls in both the groups by computing incidence ratio rates.
Approval for the conduction of this study has been taken from the Ethical Review Committee (ERC) of the institution. Evidences which will be obtained from this study will facilitate to propose changes in existing guidelines and policies for treating fall and hip fracture patients.Trial registrationThis trial is registered on clinicaltrials.gov ID: NCT04108793.
髋部骨折是全球范围内的一个主要健康问题，与发病率、死亡率的增加以及巨大的经济成本相关。成功地对髋部骨折患者进行手术治疗对于优化患者术后的活动能力和功能恢复至关重要。髋部骨折手术固定后的康复对于恢复骨折前的功能以及避免长期住院至关重要。特别是针对平衡的持续锻炼可以预防高达40%的跌倒。因此，我们设计了一项出院后居家物理康复干预计划，以尽量减少这一高危老年人群的残疾和跌倒情况。
本研究将在一家单一医院进行开放标签、简单随机对照试验。两组将按1:1的比例平均分配到干预组和对照组。对照组将接受常规的标准术后康复。干预组将在出院后每周接受两次为期3个月（12周）的强化居家康复计划。本研究的主要结局是跌倒的发生情况。两组在3、6、12和24个月时将通过研究助理的随访电话来测量跌倒情况。在长达两年的每次常规随访中，将使用基于表现的简短工具通过自我报告测试来测量与活动能力相关的残疾情况。将使用负二项回归模型通过计算发病率比来比较两组的跌倒次数。
本研究已获得该机构伦理审查委员会（ERC）的批准。从本研究中获得的证据将有助于提议对现有治疗跌倒和髋部骨折患者的指南和政策进行修改。试验注册本试验已在clinicaltrials.gov上注册，ID：NCT04108793。
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