背景:住院期间,老年患者大部分时间被动地躺在床上,这增加了功能下降和负面不良后果的风险。我们的目的是研究机器人辅助体育锻炼对老年患者急性住院期间功能状态的影响。
方法:这是一项单中心研究者盲安慰剂对照随机对照试验,包括年龄≥65岁的老年患者,能够在住院前走动,预期住院时间≥2天。除了标准的物理治疗,干预组接受主动机器人辅助的阻力训练,对照组接受被动机器人辅助的假训练.排除标准如下:纳入时无协助下行走,已知的严重痴呆症,谵妄,出院时接受少于三次培训的患者,绝症,近期大手术/下肢骨折,与训练机器人的使用条件相矛盾,下肢转移瘤,被认为不适合由医疗保健专业人员进行机器人辅助培训,或体重>165公斤。主要结果是通过纳入和出院日之间BarthelIndex-100和30-s椅子站立测试的变化来评估功能状态。次要结果包括1个月和3个月随访时的功能状态,生活质量,抑郁症,担心跌倒,falls,认知,定性访谈,需要家庭护理,排放目的地,再入院,医疗费用,少肌症,肌肉数量(生物阻抗),和死亡率。Barthel指数的临床意义变化为5分。最近一项针对老年患者的研究报告说,运动后有6.9点的变化。显著性水平为5%,80%功率,辍学率为20%,每组244名参与者(n=488)需要检测相同的平均差异。显著性水平为5%,80%功率,辍学率为20%,每组74名参与者(n=148)需要检测30-s椅子站立测试的2.6次重复的最小临床变化。招聘始于2023年1月,预计将持续19个月,包括后续行动。
结论:如果我们的研究表明医院内机器人辅助训练可以防止老年患者的功能下降,这可能会对个体患者产生重大影响,因为他们的健康增加和独立程度提高.此外,由于出院后市政提供的家庭护理需求可能减少,社会将受益。
背景:ClinicalTrials.govNCT05782855。注册日期:2023年3月24日。
BACKGROUND: During hospitalisation, older patients spend most of their time passive in bed, which increases the risk of functional decline and negative adverse outcomes. Our aim is to examine the impact of robot-assisted physical training on functional status in older geriatric patients during acute hospitalisation.
METHODS: This is a single-centre investigator-blinded placebo-controlled randomised controlled trial including geriatric patients aged ≥ 65 years, able to ambulate before hospitalisation, and with expected length of stay ≥ 2 days. In addition to standard physiotherapy treatment, the intervention group receive active robot-assisted resistance training and the control group passive robot-assisted sham training. Exclusion criteria are as follows: ambulation without assistance at the time of inclusion, known severe dementia, delirium, patients who have received less than three training sessions at discharge, terminal illness, recent major surgery/lower extremity fracture, conditions contradicting the use of training robot, lower extremity metastases, deemed unsuitable for robot-assisted training by a healthcare professional, or weight > 165 kg. The primary outcome is functional status assessed by change in Barthel Index-100 and 30-s chair stand test between inclusion and day of discharge. Secondary outcomes include functional status at 1- and 3-month follow-up, quality of life, depression, concern about falling, falls, cognition, qualitative interviews, need of homecare, discharge destination, readmissions, healthcare costs, sarcopenia, muscle quantity (bioimpedance), and mortality. Clinical meaningful change of the Barthel Index is 5 points. A recent study in geriatric patients reported a 6.9-point change following exercise. With a significance level of 5%, 80% power, and a drop-out rate of 20%, 244 participants per group (n = 488) are needed to detect the same mean difference. With a significance level of 5%, 80% power, and a drop-out rate of 20%, 74 participants per group (n = 148) are needed to detect a minimum clinical change of 2.6 repetitions for 30-s chair stand test. Recruitment started in January 2023 and is expected to continue for 19 months including follow-up.
CONCLUSIONS: If our study shows that in-hospital robot-assisted training prevents functional decline in older patients, this may have a major impact on the individual patient due to increased wellbeing and a higher level of independency. In addition, society will benefit due to potential decrease in the need of municipality-delivered homecare following discharge.
BACKGROUND: ClinicalTrials.gov NCT05782855. Registration date: March 24, 2023.