Life After STroke - the LAST Study
Condition: Cerebral Infarction; Cerebral Hemorrhage
MeSH terms: Cerebral Infarction; Cerebral Hemorrhage; Infarction; Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Long term follow up by a coordinating physiotherapist; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; Standard care as it is given to all stoke patients after stroke
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Physiotherapy; Motor training; Rehabilitation