Clinical trial NCT01467206: Life After STroke - the LAST Study
Official title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Infarction
Cerebral Hemorrhage
Keywords: Stroke
Physiotherapy
Motor training
Rehabilitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Asker & Baerum Hospital
name: The Research Council of Norway
name: Helse Midt-Norge
First posted: 2011-11-08
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor Assessment Scale
timeFrame: 18 months after inclusion
Secondary outcomes:
measure: Barthel Index
timeFrame: 18 months follow up
measure: Modified Rankin Scale
timeFrame: 18 months follow up
measure: Berg Balance Scale
timeFrame: 18 months follow up
measure: Timed Up and Go
timeFrame: 18 months follow up
measure: Sit to stand test
timeFrame: 18 months follow up
measure: Six minute walk test
timeFrame: 18 months follow up
measure: Stroke Impact Scale
timeFrame: 18 months follow up
measure: EuroQol 5D
timeFrame: 18 months follow up
measure: Fatigue Severity Scale
timeFrame: 18 months follow up
measure: One simple question on fatigue from the HUNT3 questionnaire
timeFrame: 18 months follow up
measure: Hospital Anxiety and Depression Scale
timeFrame: 18 months follow up
measure: Mini Mental State Examination
timeFrame: 18 months follow up
measure: Montreal Cognitive Assessment
timeFrame: 18 months follow up
measure: falls
timeFrame: 6, 12 and 18 months
measure: Readmission to hospital
timeFrame: 6, 12 and 18 months
measure: Death
timeFrame: 6, 12 and 18 months
measure: Fractures
timeFrame: 6, 12 and 18 months
measure: Cardiovascular events
timeFrame: 6, 12 and 18 months
measure: Cerebrovascular events
timeFrame: 6, 12 and 18 months
measure: International Physical Activity Questionnaire
timeFrame: 6, 12 and 18 months
measure: Physical activity assessed by ActivPAL sensor system
timeFrame: 6, 12 and 18 months
measure: Three simple questions on physical activity from the HUNT questionnaire
timeFrame: 18 months
measure: Health costs
timeFrame: 6, 12 and 18 months
measure: National Institutes of Health Stroke Scale
timeFrame: 18 months follow up
measure: Modified Ashworth Scale
timeFrame: 18 months follow up
measure: Gait speed
timeFrame: 18 months follow up
measure: Trailmaking test A and B
timeFrame: 18 months follow up
measure: DS-14
timeFrame: 18 months follow up
Other outcomes:
measure: VO2-peak
timeFrame: 18 months follow up
Locations:
city: Sandvika
country: Norway
facility: Bærum Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Bent Indredavik, Prof
role: STUDY_DIRECTOR
affiliation: National Taiwan Normal University
name: Torunn Askim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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;49(2):426-432. doi: 10.1161/STROKEAHA.117.018827. Epub 2017 Dec 28.
citation: Dohl O, 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. 2020 Apr 6;20(1):288. doi: 10.1186/s12913-020-05158-w.
citation: Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
citation: Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.