Life After STroke - the LAST Study

Cerebral Infarction Clinical Trial

— LAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467206
• Other study ID #: 205309/H10
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Infarction
• Hemorrhage
• Infarction

Intervention

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

Locations

Country	Name	City	State
Norway	Bærum Hospital	Sandvika
Norway	St. Olavs Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Asker & Baerum Hospital, Helse Midt-Norge, St. Olavs Hospital, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Askim T, Langhammer B, Ihle-Hansen H, Gunnes M, Lydersen S, Indredavik B; LAST Collaboration Group. Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial. Stroke. 2018 Feb; — View Citation

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. — View Citation

Døhl Ø, Halsteinli V, Askim T, Gunnes M, Ihle-Hansen H, Indredavik B, Langhammer B, Phan A, Magnussen J. Factors contributing to post-stroke health care utilization and costs, secondary results from the life after stroke (LAST) study. BMC Health Serv Res. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VO2-peak	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	18 months follow up
Primary	Motor Assessment Scale	A measure of over all motor function	18 months after inclusion
Secondary	Barthel Index	A measure of activities of daily living	18 months follow up
Secondary	Modified Rankin Scale	A measure of dependency/independency	18 months follow up
Secondary	Berg Balance Scale	A measure of balance related to basic movement tasks	18 months follow up
Secondary	Timed Up and Go	A measure of balance related to transfer and walking	18 months follow up
Secondary	Sit to stand test	A measure of dynamic muscle strength according to a sit to stand task	18 months follow up
Secondary	Six minute walk test	A measure of endurance	18 months follow up
Secondary	Stroke Impact Scale	A measure of health related quality of life after stroke	18 months follow up
Secondary	EuroQol 5D	A simple measure of health related quality of life for the general population	18 months follow up
Secondary	Fatigue Severity Scale	A measure of the presence of fatigue	18 months follow up
Secondary	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
Secondary	Hospital Anxiety and Depression Scale	A measure of anxiety and depression	18 months follow up
Secondary	Mini Mental State Examination	A measure of cognitive function	18 months follow up
Secondary	Montreal Cognitive Assessment	A measure of cognitive function related to vascular dementia	18 months follow up
Secondary	falls	Serious falls will be recorded from the patients hospital records	6, 12 and 18 months
Secondary	Readmission to hospital	Number of readmissions to hospital will be recorded from the patients medical records	6, 12 and 18 months
Secondary	Death	Information about death will be collected from the Norwegain Death Registry	6, 12 and 18 months
Secondary	Fractures	Information about fractures during follow up will be collected from the patients medical records	6, 12 and 18 months
Secondary	Cardiovascular events	Information about any cardiovascular events will be collected from the patients medical record	6, 12 and 18 months
Secondary	Cerebrovascular events	Information about any cerebrovascular events during follow up will be collected from teh patient's medical records	6, 12 and 18 months
Secondary	International Physical Activity Questionnaire	A measure of physical activity over the last week	6, 12 and 18 months
Secondary	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
Secondary	Three simple questions on physical activity from the HUNT questionnaire	A simple measure of physical activity	18 months
Secondary	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
Secondary	National Institutes of Health Stroke Scale	A measure of stroke severity	18 months follow up
Secondary	Modified Ashworth Scale	A measure to rate the degree of spasticity after stroke	18 months follow up
Secondary	Gait speed	A simple measure of maximum gait speed across a 10 metres distance	18 months follow up
Secondary	Trailmaking test A and B	A simple measure of executive cognitive function	18 months follow up
Secondary	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