Williams Nefyn, Busse Monica, Cooper Rachael, Dodd Susanna, Dorkenoo Shanaz, Doungsong Kodchawan, Edwards Rhiannon Tudor, Green Jessica, Hardwick Ben, Lemmey Andrew, Logan Phillipa, Morrison Valerie, Ralph Penelope, Sackley Catherine, Smith Benjamin Edward, Smith Toby, Spencer Llinos Haf
Department of Primary Care and Mental Health, University of Liverpool, Liverpool, UK
Centre for Trials Research, Cardiff University, Cardiff, UK.
BMJ Open. 2025 May 12;15(5):e091603. doi: 10.1136/bmjopen-2024-091603.
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants' homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI -1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.
ISRCTN28376407.
确定在髋关节骨折手术修复后，强化社区康复干预（老年人骨折多学科康复（FEMuR）干预）在日常生活活动（ADL）恢复方面是否比英国国家医疗服务体系的常规护理更有效。
确定性、务实、多中心、平行组、双臂、优效性随机对照试验，分配比例为1:1。
在英格兰和威尔士的13家医院招募参与者，FEMuR干预在社区提供。
年龄超过60岁、有精神行为能力、从髋关节骨折手术治疗中恢复且骨折前居住在自己家中的患者。
将常规康复护理（对照组）与常规康复护理加FEMuR干预进行比较，FEMuR干预包括一本患者持有的工作手册和目标设定日记以提高自我效能，以及在社区亲自提供的另外六次治疗课程，或在新冠疫情限制期间远程提供（干预组），以增加锻炼和ADL的练习。
主要结局是1个月时的诺丁汉扩展日常生活活动（NEADL）量表。次要结局包括：医院焦虑抑郁量表、跌倒自我效能量表、髋关节疼痛强度、跌倒恐惧、握力和简短体能测试电池。结局尽可能由研究助理在参与者家中收集，但在新冠疫情限制期间必须远程收集。
总共2例参与者被随机分组（n=1例实验组；n=1例对照组）。试验过程受到新冠疫情的不利影响。有2例死亡、3例退出和3例失访。在52周时，FEMuR干预组和对照组之间的NEADL评分没有显著差异。对缺失值进行调整后的纵向结局差异的联合模型分析也未发现显著差异，平均差异为0.1（95%CI -1.1, 1.3）。次要结局在组间没有显著差异。敏感性分析检查了新冠疫情限制的影响，得出了类似的结果。FEMuR干预组额外进行了中位数为4.5次的康复课程，其中亲自授课的中位数为2次。工具变量回归未发现康复量对主要结局有任何影响。有53例无关的严重不良事件（SAE），包括对照组的例死亡：FEMuR干预组有4例SAE，包括9例死亡。
FEMuR干预并不比常规康复护理更有效。该试验受到新冠疫情的严重影响。效果不佳的可能原因包括干预保真度有限（课程比计划少且远程授课）、缺乏医护人员和家庭通常水平的支持，以及疫情期间康复信念和行为的改变。
ISRCTN28376407
