Life After STroke - the LAST Study

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT01467206

Collaborator

St. Olavs Hospital (Other), Asker & Baerum Hospital (Other), The Research Council of Norway (Other), Helse Midt-Norge (Other)

380

Enrollment

Locations

Arms

Actual Duration (Months)

190

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction Cerebral Hemorrhage	Behavioral: Long term follow up by a coordinating physiotherapist Behavioral: Standard care	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long term follow up program	Behavioral: Long term follow up by a coordinating physiotherapist 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
Active Comparator: Standard care	Behavioral: Standard care Standard care as it is given to all stoke patients after stroke

Arm

Intervention/Treatment

Experimental: Long term follow up program

Behavioral: Long term follow up by a coordinating physiotherapist

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

Active Comparator: Standard care

Behavioral: Standard care

Standard care as it is given to all stoke patients after stroke

Outcome Measures

Primary Outcome Measures

Motor Assessment Scale [18 months after inclusion]
A measure of over all motor function

Secondary Outcome Measures

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
Berg Balance Scale [18 months follow up]
A measure of balance related to basic movement tasks
Timed Up and Go [18 months follow up]
A measure of balance related to transfer and walking
Sit to stand test [18 months follow up]
A measure of dynamic muscle strength according to a sit to stand task
Six minute walk test [18 months follow up]
A measure of endurance
Stroke Impact Scale [18 months follow up]
A measure of health related quality of life after stroke
EuroQol 5D [18 months follow up]
A simple measure of health related quality of life for the general population
Fatigue Severity Scale [18 months follow up]
A measure of the presence of fatigue
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
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
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
Readmission to hospital [6, 12 and 18 months]
Number of readmissions to hospital will be recorded from the patients medical records
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
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
International Physical Activity Questionnaire [6, 12 and 18 months]
A measure of physical activity over the last week
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
Three simple questions on physical activity from the HUNT questionnaire [18 months]
A simple measure of physical activity
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.
National Institutes of Health Stroke Scale [18 months follow up]
A measure of stroke severity
Modified Ashworth Scale [18 months follow up]
A measure to rate the degree of spasticity after stroke
Gait speed [18 months follow up]
A simple measure of maximum gait speed across a 10 metres distance
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.

Other Outcome Measures

VO2-peak [18 months follow up]
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