Askim Torunn, Langhammer Birgitta, Ihle-Hansen Hege, Magnussen Jon, Engstad Torgeir, Indredavik Bent
Department of Neuroscience, Faculty of Medicine, Norwegian University of Science and Technology, 7491 Trondheim, Norway ; Department of Public Health and General Practice, Faculty of Medicine, Norwegian University of Science and Technology, 7491 Trondheim, Norway.
Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.
Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health. Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion. Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.
背景。目前尚无经循证医学证实的策略被证明在中风后数月至数年维持运动功能方面更具优势。因此,LAST研究旨在评估与标准护理相比,中风患者长期随访计划对功能、残疾和健康状况的影响。设计。这是一项前瞻性、多中心随机对照试验,入组18个月后进行盲法评估。总共将招募390名患者,并随机分为对照组(接受常规护理)或干预组(中风发病10至16周后)。患者将根据中风严重程度、80岁以上年龄和招募地点进行分层。干预组在入组后将连续18个月每月接受物理治疗师关于身体活动的指导。结局。主要结局是入组18个月后的运动功能(运动评估量表)。次要结局包括:依赖性、平衡能力、耐力、健康相关生活质量、疲劳、焦虑和抑郁、认知功能、照顾者负担以及健康成本。在随访期间将连续记录不良事件和干预措施的依从性。