Life After STroke - the LAST Study (LAST)
Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
研究概览
详细说明
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.
Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site), gender, and cognitive status (Mini Mental State below 25), to explore trends within subgroups of patients.
Missing values will be handled using single imputation (typically for items on instrument scales), or by multiple imputation, as appropriate.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sandvika、挪威
- Bærum Hospital
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Trondheim、挪威
- St. Olavs Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：标准护理
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Standard care as it is given to all stoke patients after stroke
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实验性的：Long term follow up program
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Monthly meetings with an coordinating physiotherapist who motivate and encourage the patient to do 60 minutes of weekly exercise and 30 minutes of daily physical activity
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Motor Assessment Scale
大体时间：18 months after inclusion
|
A measure of over all motor function
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18 months after inclusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Barthel Index
大体时间：18 months follow up
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A measure of activities of daily living
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18 months follow up
|
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Modified Rankin Scale
大体时间：18 months follow up
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A measure of dependency/independency
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18 months follow up
|
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Berg Balance Scale
大体时间：18 months follow up
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A measure of balance related to basic movement tasks
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18 months follow up
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Timed Up and Go
大体时间：18 months follow up
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A measure of balance related to transfer and walking
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18 months follow up
|
|
Sit to stand test
大体时间：18 months follow up
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A measure of dynamic muscle strength according to a sit to stand task
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18 months follow up
|
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Six minute walk test
大体时间：18 months follow up
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A measure of endurance
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18 months follow up
|
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Stroke Impact Scale
大体时间：18 months follow up
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A measure of health related quality of life after stroke
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18 months follow up
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EuroQol 5D
大体时间：18 months follow up
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A simple measure of health related quality of life for the general population
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18 months follow up
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Fatigue Severity Scale
大体时间：18 months follow up
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A measure of the presence of fatigue
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18 months follow up
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One simple question on fatigue from the HUNT3 questionnaire
大体时间：18 months follow up
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A simple question used to assess tiredness in teh general Norwegian population
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18 months follow up
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Hospital Anxiety and Depression Scale
大体时间：18 months follow up
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A measure of anxiety and depression
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18 months follow up
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Mini Mental State Examination
大体时间：18 months follow up
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A measure of cognitive function
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18 months follow up
|
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Montreal Cognitive Assessment
大体时间：18 months follow up
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A measure of cognitive function related to vascular dementia
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18 months follow up
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|
falls
大体时间：6, 12 and 18 months
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Serious falls will be recorded from the patients hospital records
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6, 12 and 18 months
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Readmission to hospital
大体时间：6, 12 and 18 months
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Number of readmissions to hospital will be recorded from the patients medical records
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6, 12 and 18 months
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Death
大体时间：6, 12 and 18 months
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Information about death will be collected from the Norwegain Death Registry
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6, 12 and 18 months
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Fractures
大体时间：6, 12 and 18 months
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Information about fractures during follow up will be collected from the patients medical records
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6, 12 and 18 months
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Cardiovascular events
大体时间：6, 12 and 18 months
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Information about any cardiovascular events will be collected from the patients medical record
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6, 12 and 18 months
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Cerebrovascular events
大体时间：6, 12 and 18 months
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Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
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6, 12 and 18 months
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International Physical Activity Questionnaire
大体时间：6, 12 and 18 months
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A measure of physical activity over the last week
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6, 12 and 18 months
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Physical activity assessed by ActivPAL sensor system
大体时间：6, 12 and 18 months
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A sensor system to assess the amount of physical activity during a 4-7 day period
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6, 12 and 18 months
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Three simple questions on physical activity from the HUNT questionnaire
大体时间：18 months
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A simple measure of physical activity
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18 months
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Health costs
大体时间：6, 12 and 18 months
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Information about the use of health services will be collected by reviewing the patients' hospital records and records in primary health care system.
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6, 12 and 18 months
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National Institutes of Health Stroke Scale
大体时间：18 months follow up
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A measure of stroke severity
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18 months follow up
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Modified Ashworth Scale
大体时间：18 months follow up
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A measure to rate the degree of spasticity after stroke
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18 months follow up
|
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Gait speed
大体时间：18 months follow up
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A simple measure of maximum gait speed across a 10 metres distance
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18 months follow up
|
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Trailmaking test A and B
大体时间：18 months follow up
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A simple measure of executive cognitive function
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18 months follow up
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DS-14
大体时间：18 months follow up
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A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.
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18 months follow up
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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VO2-peak
大体时间：18 months follow up
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VO2-peak is obtained by use of a symptom limited treadmill test to measure cardiovascular fitness. This measure is only used in the Trondheim arm of the study |
18 months follow up
|
合作者和调查者
调查人员
- 研究主任：Bent Indredavik, Prof、National Taiwan Normal University
- 首席研究员：Torunn Askim, PhD、National Taiwan Normal University
出版物和有用的链接
一般刊物
- 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.
- Askim T, Langhammer B, Ihle-Hansen H, Gunnes M, Lydersen S, Indredavik B; LAST Collaboration Group. Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial. Stroke. 2018 Feb;49(2):426-432. doi: 10.1161/STROKEAHA.117.018827. Epub 2017 Dec 28.
- Dohl O, Halsteinli V, Askim T, Gunnes M, Ihle-Hansen H, Indredavik B, Langhammer B, Phan A, Magnussen J. Factors contributing to post-stroke health care utilization and costs, secondary results from the life after stroke (LAST) study. BMC Health Serv Res. 2020 Apr 6;20(1):288. doi: 10.1186/s12913-020-05158-w.
- Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6:CD012996. doi: 10.1002/14651858.CD012996.pub2.
- Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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