Life After STroke - the LAST Study "LAST"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Standard Care Other
    Intervention Desc: Standard care as it is given to all stoke patients after stroke
    ARM 1: Kind: Experimental
    Label: Standard care
  • Long term follow up by a coordinating physiotherapist Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Long term follow up program

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor Assessment Scale 18 months after inclusion No
Secondary Barthel Index 18 months follow up No
Secondary Modified Rankin Scale 18 months follow up No
Secondary Berg Balance Scale 18 months follow up No
Secondary Timed Up and Go 18 months follow up No
Secondary Sit to stand test 18 months follow up No
Secondary Six minute walk test 18 months follow up No
Secondary Stroke Impact Scale 18 months follow up No
Secondary EuroQol 5D 18 months follow up No
Secondary Fatigue Severity Scale 18 months follow up No
Secondary One simple question on fatigue from the HUNT3 questionnaire 18 months follow up No
Secondary Hospital Anxiety and Depression Scale 18 months follow up No
Secondary Mini Mental State Examination 18 months follow up No
Secondary Montreal Cognitive Assessment 18 months follow up No
Secondary falls 6, 12 and 18 months No
Secondary Readmission to hospital 6, 12 and 18 months No
Secondary Death 6, 12 and 18 months No
Secondary Fractures 6, 12 and 18 months No
Secondary Cardiovascular events 6, 12 and 18 months No
Secondary Cerebrovascular events 6, 12 and 18 months No
Secondary International Physical Activity Questionnaire Every sixth month No
Secondary Physical activity assessed by ActivPAL sensor system 6, 12 and 18 months No
Secondary Three simple questions on physical activity from the HUNT questionnaire 18 months No
Secondary Health costs 6, 12 and 18 months No
Secondary National Institutes of Health Stroke Scale 18 months follow up No
Secondary Modified Ashworth Scale 18 months follow up No
Secondary Gait speed 18 months follow up No
Secondary Trailmaking test A and B 18 months follow up No
Secondary DS-14 18 months follow up No

Sponsors