背景:人口的进行性老龄化意味着需要紧急手术的老年患者的增加。老年人,尤其是那些虚弱的人,有更高的并发症风险,紧急手术后的功能和认知功能下降。这些患者的功能和生理储备减少,这使他们更容易受到卧床不起的影响。后果是在多个层面强调功能丧失或认知障碍,更长时间的停留,死亡率和制度化,谵妄,生活质量差,与健康相关的资源使用增加。我们旨在确定术后物理康复是否可以预防功能和认知能力下降并改变后路轨迹。
方法:本研究是一项随机临床试验,简单的失明,在纳瓦拉三级公立医院(纳瓦拉大学医院)的外科进行,西班牙。符合纳入标准的>=70岁接受紧急腹部手术的患者将被随机分配到干预组或对照组。干预将包括一个多部分的体能训练计划,这将包括进步和监督耐力,抵抗和平衡训练4周,每周两次,共8次,对照组将接受常规护理。主要结果指标是研究期间功能(SPPB)和认知状态(迷你精神状态检查)的变化以及生活质量(EuroQol-5D-VAS)的变化。次要结果是术后并发症,逗留时间,谵妄,死亡率,利用卫生资源,功能状态(Barthel指数和手握强度测试),每个质量调整生命年的成本和微量营养素评估。干预组和对照组的数据将在四个不同的时间获得:入院期间的初次就诊以及出院后的1、3和6个月。
结论:如果我们的假设是正确的,该项目可以表明,个性化和渐进式锻炼计划为提高功能能力和实现更好的功能提供了有效的治疗,认知和生活质量恢复。这项措施,在不给政府带来大量费用的情况下,可能在短期和长期复苏中都有重要影响,改善护理和功能参数,并可以确定后续对卫生资源的需求较低。为了验证这一点,我们将进行成本效益研究。如果我们帮助将老年患者的传统管理从疾病模型转变为更加以人为本和功能导向的观点,则该试验的临床影响可能是显着的。此外,个性化运动的处方可以常规地纳入这些患者的临床实践中.
背景:ClinicalTrials.gov标识符:NCT05290532。版本1。2022年3月13日注册。
BACKGROUND: The progressive aging of the population has meant the increase in elderly patients requiring an urgent surgery. Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. We aim to determine whether postoperative physical rehabilitation can prevent functional and cognitive decline and modify the posterior trajectory.
METHODS: This study is a randomized clinical trial, simple blinded, conducted in the Department of Surgery of a tertiary public hospital in Navarra (Hospital Universitario de Navarra), Spain. Patients > = 70 years old undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent physical training programme, which will include progressive and supervised endurance, resistance and balance training for 4 weeks, twice weekly sessions with a total of 8 sessions, and the group control will receive the usual care. The primary outcome measure is the change in functional (SPPB) and cognitive status (Mini-Mental State Examination) and the change of quality of life (EuroQol-5D-VAS) during the study period. The secondary outcomes are postoperative complications, length of stay, delirium, mortality, use of health resources, functional status (Barthel Index and handgrip strength tests), cost per quality-adjusted life year and mininutritional assessment. The data for both the intervention group and the control group will be obtained at four different times: the initial visit during hospital admission and at months 1, 3 and 6 months after hospital discharge.
CONCLUSIONS: If our hypothesis is correct, this project could show that individualized and progressive exercise programme provides effective therapy for improving the functional capacity and achieve a better functional, cognitive and quality of life recovery. This measure, without entailing a significant expense for the administration, probably has an important repercussion both in the short- and long-term recovery, improving care and functional parameters and could determine a lower subsequent need for health resources. To verify this, we will carry out a cost-effectiveness study. The clinical impact of this trial can be significant if we help to modify the traditional management of the elderly patients from an illness model to a more person-centred and functionally oriented perspective. Moreover, the prescription of individualized exercise can be routinely included in the clinical practice of these patients.
BACKGROUND: ClinicalTrials.gov Identifier: NCT05290532. Version 1. Registered on March 13, 2022.