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

居家康复计划在最大限度减少髋部骨折后残疾和二次跌倒方面的有效性:一项随机对照试验方案

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Abstract

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

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