Life After STroke - the LAST Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial

Conditions
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Cerebral Infarction, Cerebral Hemorrhage

Intervention / Treatment
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* Behavioral: Long term follow up by a coordinating physiotherapist
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long term follow up program<br> | Behavioral: Long term follow up by a coordinating physiotherapist<br>* 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<br>|
| Active Comparator: Standard care<br> | Behavioral: Standard care<br>* Standard care as it is given to all stoke patients after stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Assessment Scale | A measure of over all motor function | 18 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | A measure of activities of daily living | 18 months follow up | 
| Modified Rankin Scale | A measure of dependency/independency | 18 months follow up | 
| Berg Balance Scale | A measure of balance related to basic movement tasks | 18 months follow up | 
| Timed Up and Go | A measure of balance related to transfer and walking | 18 months follow up | 
| Sit to stand test | A measure of dynamic muscle strength according to a sit to stand task | 18 months follow up | 
| Six minute walk test | A measure of endurance | 18 months follow up | 
| Stroke Impact Scale | A measure of health related quality of life after stroke | 18 months follow up | 
| EuroQol 5D | A simple measure of health related quality of life for the general population | 18 months follow up | 
| Fatigue Severity Scale | A measure of the presence of fatigue | 18 months follow up | 
| One simple question on fatigue from the HUNT3 questionnaire | A simple question used to assess tiredness in teh general Norwegian population | 18 months follow up | 
| Hospital Anxiety and Depression Scale | A measure of anxiety and depression | 18 months follow up | 
| Mini Mental State Examination | A measure of cognitive function | 18 months follow up | 
| Montreal Cognitive Assessment | A measure of cognitive function related to vascular dementia | 18 months follow up | 
| falls | Serious falls will be recorded from the patients hospital records | 6, 12 and 18 months | 
| Readmission to hospital | Number of readmissions to hospital will be recorded from the patients medical records | 6, 12 and 18 months | 
| Death | Information about death will be collected from the Norwegain Death Registry | 6, 12 and 18 months | 
| Fractures | Information about fractures during follow up will be collected from the patients medical records | 6, 12 and 18 months | 
| Cardiovascular events | Information about any cardiovascular events will be collected from the patients medical record | 6, 12 and 18 months | 
| Cerebrovascular events | Information about any cerebrovascular events during follow up will be collected from teh patient's medical records | 6, 12 and 18 months | 
| International Physical Activity Questionnaire | A measure of physical activity over the last week | 6, 12 and 18 months | 
| Physical activity assessed by ActivPAL sensor system | A sensor system to assess the amount of physical activity during a 4-7 day period | 6, 12 and 18 months | 
| Three simple questions on physical activity from the HUNT questionnaire | A simple measure of physical activity | 18 months | 
| Health costs | Information about the use of health services will be collected by reviewing the patients' hospital records and records in primary health care system. | 6, 12 and 18 months | 
| National Institutes of Health Stroke Scale | A measure of stroke severity | 18 months follow up | 
| Modified Ashworth Scale | A measure to rate the degree of spasticity after stroke | 18 months follow up | 
| Gait speed | A simple measure of maximum gait speed across a 10 metres distance | 18 months follow up | 
| Trailmaking test A and B | A simple measure of executive cognitive function | 18 months follow up | 
| DS-14 | A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis. | 18 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Physiotherapy, Motor training, Rehabilitation