Life After STroke - the LAST Study
- Conditions
- Cerebral InfarctionCerebral Hemorrhage
- Interventions
- Behavioral: Standard careBehavioral: Long term follow up by a coordinating physiotherapist
- Registration Number
- NCT01467206
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care Standard care - Long term follow up program Long term follow up by a coordinating physiotherapist -
- Primary Outcome Measures
Name Time Method Motor Assessment Scale 18 months after inclusion A measure of over all motor function
- Secondary Outcome Measures
Name Time Method Barthel Index 18 months follow up A measure of activities of daily living
Modified Rankin Scale 18 months follow up A measure of dependency/independency
Timed Up and Go 18 months follow up A measure of balance related to transfer and walking
Stroke Impact Scale 18 months follow up A measure of health related quality of life after stroke
Montreal Cognitive Assessment 18 months follow up A measure of cognitive function related to vascular dementia
falls 6, 12 and 18 months Serious falls will be recorded from the patients hospital records
Cardiovascular events 6, 12 and 18 months Information about any cardiovascular events will be collected from the patients medical record
Cerebrovascular events 6, 12 and 18 months Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
Health costs 6, 12 and 18 months Information about the use of health services will be collected by reviewing the patients' hospital records and records in primary health care system.
Berg Balance Scale 18 months follow up A measure of balance related to basic movement tasks
Six minute walk test 18 months follow up A measure of endurance
One simple question on fatigue from the HUNT3 questionnaire 18 months follow up A simple question used to assess tiredness in teh general Norwegian population
Readmission to hospital 6, 12 and 18 months Number of readmissions to hospital will be recorded from the patients medical records
EuroQol 5D 18 months follow up A simple measure of health related quality of life for the general population
Hospital Anxiety and Depression Scale 18 months follow up A measure of anxiety and depression
Mini Mental State Examination 18 months follow up A measure of cognitive function
Physical activity assessed by ActivPAL sensor system 6, 12 and 18 months A sensor system to assess the amount of physical activity during a 4-7 day period
Gait speed 18 months follow up A simple measure of maximum gait speed across a 10 metres distance
Sit to stand test 18 months follow up A measure of dynamic muscle strength according to a sit to stand task
Fatigue Severity Scale 18 months follow up A measure of the presence of fatigue
Death 6, 12 and 18 months Information about death will be collected from the Norwegain Death Registry
Fractures 6, 12 and 18 months Information about fractures during follow up will be collected from the patients medical records
International Physical Activity Questionnaire 6, 12 and 18 months A measure of physical activity over the last week
National Institutes of Health Stroke Scale 18 months follow up A measure of stroke severity
Trailmaking test A and B 18 months follow up A simple measure of executive cognitive function
DS-14 18 months follow up A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.
Three simple questions on physical activity from the HUNT questionnaire 18 months A simple measure of physical activity
Modified Ashworth Scale 18 months follow up A measure to rate the degree of spasticity after stroke
Trial Locations
- Locations (2)
St. Olavs Hospital
🇳🇴Trondheim, Norway
Bærum Hospital
🇳🇴Sandvika, Norway