Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Motor Assessment Scale
研究概览
简要总结
The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.
详细描述
Supplement to the Life After Stroke - the LAST study ClinicalTrials.gov ID: NCT01467206
Changes in the planned statistical analysis, November 9, 2015 The original plan for statistical analysis was published in; Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.
Original plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Mann-Whitney U test will be used for secondary data not being normal distributed. In all analyses we will control for potential confounding factors, investigate effect modifications, and present both unadjusted and adjusted effects with 95% confidence intervals.
Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site) to explore trends within subgroups of patients.
Revised plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Similar ANCOVA analyses will be used for the relevant secondary endpoints. Mann-Whitney U test will be used for secondary data not being normal distributed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke according to WHO's definition of stroke
- •Living in the city of Trondheim or the municipalities of Asker or Bærum
- •Included 2.5 - 4 months after stroke
- •Modified Rankin Scale 0 - 4
- •Living at home
- •Mini Mental State Examination > 20 or > 16 if aphasia
- •Provide informed consent
排除标准
- •Are already included in the study
- •Are included in other experimental studies
- •Unstable coronary function
- •Uncompensated heartfailure
- •Other diseases that make it difficult to complete the intervention
研究组 & 干预措施
Long term follow up program
干预措施: Long term follow up by a coordinating physiotherapist (Behavioral)
Standard care
干预措施: Standard care (Behavioral)
结局指标
主要结局
Motor Assessment Scale
时间窗: 18 months after inclusion
A measure of over all motor function
次要结局
- Gait speed(18 months follow up)
- Barthel Index(18 months follow up)
- Modified Rankin Scale(18 months follow up)
- Timed Up and Go(18 months follow up)
- Stroke Impact Scale(18 months follow up)
- Montreal Cognitive Assessment(18 months follow up)
- falls(6, 12 and 18 months)
- Cardiovascular events(6, 12 and 18 months)
- Cerebrovascular events(6, 12 and 18 months)
- Health costs(6, 12 and 18 months)
- Berg Balance Scale(18 months follow up)
- Six minute walk test(18 months follow up)
- One simple question on fatigue from the HUNT3 questionnaire(18 months follow up)
- Readmission to hospital(6, 12 and 18 months)
- EuroQol 5D(18 months follow up)
- Hospital Anxiety and Depression Scale(18 months follow up)
- Mini Mental State Examination(18 months follow up)
- Physical activity assessed by ActivPAL sensor system(6, 12 and 18 months)
- Sit to stand test(18 months follow up)
- Fatigue Severity Scale(18 months follow up)
- Death(6, 12 and 18 months)
- Fractures(6, 12 and 18 months)
- International Physical Activity Questionnaire(6, 12 and 18 months)
- National Institutes of Health Stroke Scale(18 months follow up)
- Trailmaking test A and B(18 months follow up)
- DS-14(18 months follow up)
- Three simple questions on physical activity from the HUNT questionnaire(18 months)
- Modified Ashworth Scale(18 months follow up)