家庭康复计划在减少髋部骨折后残疾和继发跌倒方面的有效性:一项随机对照试验方案

Anum Sadruddin Pidani , Saniya Sabzwari , Khabir Ahmad , Ata Mohammed , Shahryar Noordin
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引用次数: 2

摘要

髋部骨折是一个全球性的主要健康问题,与发病率、死亡率增加和巨大的经济成本有关。髋部骨折患者成功的手术治疗是优化患者术后活动能力和功能恢复的必要条件。髋部骨折手术稳定后的康复是恢复骨折前功能和避免长期住院的关键。特别是以平衡为目标的持续运动可以防止高达40%的跌倒。因此,我们设计了一个出院后家庭康复干预方案,以减少这一高危老年人群的残疾和跌倒。方法与分析该研究将是在一家医院进行的开放标签、简单随机对照试验。这两支手臂将按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。干预组将接受延长的家庭康复计划,每周两次,持续3 个月(12 周)。研究的主要结果是跌倒的发生率。研究助理将在3、6、12和24 个月时对两组的跌倒情况进行跟踪电话调查。在长达两年的每次常规随访中,将使用基于性能的短电池工具进行自我报告测试,以测量与行动相关的残疾。采用负二项回归模型,通过计算发病率,比较两组的跌倒次数。伦理和传播本研究的开展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出改变现有治疗跌倒和髋部骨折患者的指南和政策。试验注册本试验在clinicaltrials.gov上注册,ID: NCT04108793。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized controlled trial

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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 registration

This trial is registered on clinicaltrials.gov ID: NCT04108793.

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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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