Heiberg Kristi Elisabeth, Bruun-Olsen Vigdis, Bergland Astrid
Clinic of Bærum Hospital, Department of Medical Research, Bærum Hospital, Vestre Viken Hospital Trust, 3004, Drammen, Norway.
Oslo and Akershus University College, Oslo, Norway.
BMC Geriatr. 2017 Jan 17;17(1):23. doi: 10.1186/s12877-016-0398-8.
The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. Rehabilitation is important to improve physical functioning after hip fracture. To maintain the continuity in rehabilitation we have an assumption that it is of utmost importance to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.
METHODS/DESIGN: Inclusion and randomization will take place during hospital stay. All patients 65 years or above who have sustained a hip fracture are eligible, except if they have a score on Mini Mental State (MMS-E) of less than 15, could walk less than 10 m prior to the fracture, or are terminally ill. The intervention consists of additional functional training as part of the habitual daily routine during short term stays at nursing homes after discharge from hospital. The primary outcome is physical functioning measured by the Short Physical Performance Battery (SPPB). Secondary outcomes are Timed "Up & Go" (TUG), hand grip strength, activPAL accelerometer, and self-reported measures like new Mobility Score (NMS), Walking Habits, University of California Los Angeles (UCLA) activity scale, Fall efficacy scale (FES), EuroQol health status measure (EQ-5D-5 L), and pain.
Issues related to internal and external validity in the study are discussed. The outline for the arguments in this protocol is organized according to the guidelines of the Medical Research Council (MRC) guidance on how to develop and evaluate complex interventions.
ClinicalTrials.gov NCT02780076 .
髋部骨折幸存者常报告有剧痛和身体功能丧失。这些不良后果会对患者的身体功能和生活质量产生负面影响，并给社会带来经济负担。康复对于改善髋部骨折后的身体功能很重要。为保持康复的连续性，我们有一个假设，即在患者出院回家前转至养老院短期居住期间，继续并推进已在医院开始的功能训练至关重要。目前的目的是研究由物理治疗师发起、护士执行的功能训练计划对患者在初级卫生保健机构短期居住期间身体功能的影响。
方法/设计：纳入和随机分组将在住院期间进行。所有65岁及以上的髋部骨折患者均符合条件，但简易精神状态检查量表（MMS-E）得分低于15分、骨折前行走距离不足10米或处于终末期疾病的患者除外。干预措施包括在出院后于养老院短期居住期间作为日常惯常活动一部分的额外功能训练。主要结局是通过简短身体功能测试量表（SPPB）测量的身体功能。次要结局包括计时起立行走测试（TUG）、握力、activPAL加速度计以及自我报告的测量指标，如新活动能力评分（NMS）、行走习惯、加利福尼亚大学洛杉矶分校（UCLA）活动量表、跌倒效能量表（FES）、欧洲五维度健康量表（EQ-5D-5L）和疼痛。
讨论了研究中与内部和外部效度相关的问题。本方案中的论证大纲是根据医学研究理事会（MRC）关于如何制定和评估复杂干预措施的指南组织的。
ClinicalTrials.gov NCT02780076 。
